sandoz inc - Medication Listings

Estradiol transdermal system contains estradiol in a multipolymeric adhesive. The system is designed to release estradiol continuously upon application to intact skin. Five dosage strengths of estradiol transdermal system are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol per day via the skin. Each corresponding system has an active surface area of 2.5, 3.75, 5.0, 7.5, or 10.0 cm 2 and contains 0.39, 0.585, 0.78, 1.17, or 1.56 mg of estradiol USP, respectively. The composition of the systems per unit area is identical. Estradiol USP is a white, crystalline powder, chemically described as estra-1,3,5 (10)-triene-3,17β-diol. The structural formula is: The molecular formula of estradiol is C 18 H 24 0 2. The molecular weight is 272.39 g/mol. Estradiol transdermal system is comprised of 3 layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) a translucent polyolefin film (2) an adhesive formulation containing estradiol, acrylic adhesive, silicone adhesive, oleyl alcohol, NF, povidone, USP and dipropylene glycol, and (3) a polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. ----- (1) Backing ----- (2) Adhesive Containing Estradiol ----- (3) Protective Liner The active component of the system is estradiol. The remaining components of the system are pharmacologically inactive. Estradiol structural formula Estradiol Transdermal System - Layers

The Estradiol Transdermal System (estradiol transdermal system), is designed to release estradiol continuously upon application to intact skin. Six (6.5, 9.375, 12.5, 15, 18.75 and 25 cm 2 ) systems are available to provide nominal in vivo delivery of 0.025, 0.0375, 0.05, 0.06, 0.075 or 0.1 mg respectively of estradiol per day. The period of use is 7 days. Each system has a contact surface area of either 6.5, 9.375, 12.5, 15, 18.75 or 25 cm 2 , and contains 2, 2.85, 3.8, 4.55, 5.7 or 7.6 mg of estradiol USP respectively. The composition of the systems per unit area is identical. Estradiol USP is a white, crystalline powder, chemically described as estra-1,3,5(10)-triene-3, 17β-diol. It has an empirical formula of C 18 H 24 O 2 and molecular weight of 272.38. The structural formula is: The Estradiol Transdermal System transdermal system comprises three layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are: 1. A translucent polyethylene film. 2. An acrylate adhesive matrix containing estradiol USP. 3. A protective liner of siliconized or fluoropolymer-coated polyester film is attached to the adhesive surface and must be removed before the system can be used. The active component of the transdermal system is estradiol. The remaining components of the transdermal system (acrylate copolymer adhesive, fatty acid esters, and polyethylene backing) are pharmacologically inactive. Chemical Structure Patch Diagram

Estradiol Valerate and Estradiol Valerate/Dienogest tablets provide an oral contraceptive regimen consisting of 26 active film-coated tablets that contain the active ingredients specified for each tablet below, followed by two inert film-coated tablets: • 2 dark yellow tablets each containing 3 mg estradiol valerate • 5 medium red tablets each containing 2 mg estradiol valerate and 2 mg dienogest • 17 light yellow tablets each containing 2 mg estradiol valerate and 3 mg dienogest • 2 dark red tablets each containing 1 mg estradiol valerate • 2 white tablets (inert) Estradiol Valerate and Estradiol Valerate/Dienogest also contains the excipients lactose monohydrate, maize starch, maize starch pre-gelatinized, povidone 25, magnesium stearate, hypromellose, macrogol 6000, talc, titanium dioxide, and ferric oxide pigment, yellow, or ferric oxide pigment, red. The empirical formula of estradiol valerate is C 23 H 32 O 3 and the chemical structure is: Estradiol Valerate Estradiol Valerate The chemical name of estradiol valerate is Estra-1,3,5(10)-triene-3,17-diol(17ß)-,17-pentanoate. The empirical formula of dienogest is C 20 H 25 NO 2 and the chemical structure is: Dienogest Dienogest The chemical name of dienogest is (17α)-17-Hydroxy-3-oxo-19-norpregna-4,9-diene-21-nitrile. EV Chem Struc Dien Chem Struc

EXELON PATCH (rivastigmine transdermal system) contains rivastigmine, a reversible cholinesterase inhibitor known chemically as (S)-3-[1-(dimethylamino) ethyl]phenyl ethylmethylcarbamate. It has an empirical formula of C 14 H 22 N 2 O 2 as the base and a molecular weight of 250.34 g/mol (as the base). Rivastigmine is a viscous, clear, and colorless to yellow to very slightly brown liquid that is sparingly soluble in water and very soluble in ethanol, acetonitrile, n-octanol and ethyl acetate. The distribution coefficient at 37°C in n-octanol/phosphate buffer solution pH 7 is 4.27. EXELON PATCH is for transdermal administration. The patch is a 4-layer laminate containing the backing layer, drug matrix, adhesive matrix and overlapping release liner (see Figure 1). The release liner is removed and discarded prior to use. Figure 1: Cross Section of the EXELON PATCH Layer 1: Backing Film Layer 2: Drug Product (Acrylic) Matrix Layer 3: Adhesive (Silicone) Matrix Layer 4: Release Liner (removed at time of use) Excipients within the formulation include acrylic copolymer, poly (butylmethacrylate, methylmethacrylate), silicone adhesive applied to a flexible polymer backing film, silicone oil, and vitamin E. rivastigmine chemical structure Figure 1: Cross Section of the EXELON PATCH

Ezetimibe is in a class of lipid-lowering compounds that selectively inhibits the intestinal absorption of cholesterol and related phytosterols. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C 24 H 21 F 2 NO 3 . Its molecular weight is 409.4 and its structural formula is: Ezetimibe, USP is a white to off-white crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Ezetimibe has a melting point of about 163°C and is stable at ambient temperature. Ezetimibe is available as a tablet for oral administration containing 10 mg of ezetimibe and the following inactive ingredients: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. structural formula

Ferumoxytol is an iron replacement product containing ferumoxytol for intravenous infusion. Ferumoxytol is a non-stoichiometric magnetite (superparamagnetic iron oxide) coated with polyglucose sorbitol carboxymethylether. The overall colloidal particle size is 17 to 31 nm in diameter. The chemical formula of ferumoxytol is Fe 5874 O 8752 -C 11719 H 18682 O 9933 Na 414 with an apparent molecular weight of 750 kDa. Ferumoxytol injection is a sterile aqueous colloidal product that is formulated with mannitol. It is a reddish brown liquid, and is provided in single-dose vials containing 510 mg of elemental iron. Each mL of the sterile colloidal solution of ferumoxytol injection contains 30 mg of elemental iron and 44 mg of mannitol, and 30 mg polyglucose sorbitol carboxymethylether. The formulation is isotonic with an osmolality of 270 to 330 mOsm/kg. The product contains no preservatives, and has a pH of 6 to 8.

Fluvastatin sodium inhibits 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Fluvastatin sodium is [ R *, S *-( E )]-(±)-7-[3-(4-fluorophenyl)-1-(1-methylethyl)-1 H -indol-2-yl]-3,5-dihydroxy-6-heptenoic acid, monosodium salt. The empirical formula of fluvastatin sodium is C 24 H 25 FNO 4 •Na, its molecular weight is 433.46 g/mol and its structural formula is: Fluvastatin sodium is a white to pale yellow, hygroscopic powder soluble in water, ethanol and methanol. Fluvastatin sodium is supplied as extended-release tablets containing 84.24 mg of fluvastatin sodium, equivalent to 80 mg of fluvastatin, for oral use. Fluvastatin sodium extended-release tablets contain the following inactive ingredients: hydroxypropyl cellulose, hydroxypropyl methyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 8000, potassium bicarbonate, povidone, titanium dioxide, and yellow iron oxide. Fluvastatin sodium structural formula

Focalin contains dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d-threo enantiomer of racemic methylphenidate hydrochloride. Focalin is available as 2.5 mg, 5 mg, and 10 mg strength tablets for oral administration. Chemically, dexmethylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, (R,R’)-(+)-. Its molecular formula is C 14 H 19 NO 2 •HCl. Its structural formula is: Note: * = asymmetric carbon centers Dexmethylphenidate hydrochloride is a white to off-white powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Inactive ingredients: FD&C blue no.1 #5516 aluminum lake (2.5 mg tablets), D&C yellow #10 aluminum lake (5 mg tablets), the 10 mg tablet contains no dye; lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch and sodium starch glycolate. Dexmethylphenidate hydrochloride structural formula.

Focalin XR contains dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d-threo enantiomer of racemic methylphenidate hydrochloride. Focalin XR is an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Each bead-filled Focalin XR capsule contains half the dose as immediate-release beads and half as enteric-coated, delayed-release beads, thus providing an immediate release of dexmethylphenidate and a delayed release of dexmethylphenidate. Focalin XR is intended for oral administration and is available as 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, and 40 mg extended-release capsules. Chemically, dexmethylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, (R,R’)-(+)-. Its molecular formula is C 14 H 19 NO 2 •HCl. Its structural formula is: Note* = asymmetric carbon center Dexmethylphenidate hydrochloride is a white to off-white powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Inactive ingredients: ammonio methacrylate copolymer, gelatin, methacrylic acid copolymer, polyethylene glycol, sugar spheres, talc, titanium dioxide, and triethyl citrate. Each strength capsule also contains colorant ingredients in the capsule shell as follows: • 5 mg: E132 FD&C Blue No. 2 • 10 mg: FDA/E172 iron oxide yellow • 15 mg: FD&C Blue No. 2, FDA/E172 iron oxide yellow • 20 mg: contains no colorants • 25 mg: E132 FD&C Blue No. 2 • 30 mg: FDA/E172 iron oxide yellow • 35 mg: E132 FD&C Blue No. 2, FDA/E172 iron oxide yellow • 40 mg: E132 FD&C Blue No. 2, FDA/E172 iron oxide yellow Dexmethylphenidate hydrochloride structural formula.

Fondaparinux sodium injection, USP is a sterile solution containing fondaparinux sodium. It is a synthetic and specific inhibitor of activated Factor X (Xa). Fondaparinux sodium is methyl O-2-deoxy-6-O-sulfo-2-(sulfoamino)-α-D-glucopyranosyl-(1→4)-O-β-D-glucopyra- nuronosyl-(1→4)-O-2-deoxy-3,6-di-O-sulfo-2-(sulfoamino)-α-D-glucopyranosyl-(1→4)-O-2-O- sulfo-α-L-idopyranuronosyl-(1→4)-2-deoxy-6-O-sulfo-2-(sulfoamino)-α-D-glucopyranoside, decasodium salt. The molecular formula of fondaparinux sodium is C31H43N3Na10O49S8 and its molecular weight is 1728. The structural formula is provided below: Fondaparinux sodium injection, USP is supplied as a sterile, preservative-free injectable solution for subcutaneous use. Each single-dose, prefilled syringe of fondaparinux sodium injection, USP, affixed with an automatic needle protection system, contains 2.5 mg of fondaparinux sodium in 0.5 mL, 5 mg of fondaparinux sodium in 0.4 mL, 7.5 mg of fondaparinux sodium in 0.6 mL, or 10 mg of fondaparinux sodium in 0.8 mL of an isotonic solution of sodium chloride and water for injection. May also contain sodium hydroxide and/or hydrochloric acid as pH adjusters. The final drug product is a clear and colorless to slightly yellow liquid with a pH between 5 and 8. image description

Fulvestrant injection for intramuscular administration is an estrogen receptor antagonist. The chemical name is 7-alpha-[9-(4,4,5,5,5-penta fluoropentylsulphinyl) nonyl]estra-1,3,5-(10)- triene-3,17-beta-diol. The molecular formula is C 32 H 47 F 5 O 3 S and its structural formula is: Fulvestrant is a white powder with a molecular weight of 606.77. The solution for injection is a clear, colorless to yellow, viscous liquid. Each injection contains as inactive ingredients: 10% w/v Alcohol, 10% w/v Benzyl Alcohol, and 15% w/v Benzyl Benzoate, as co-solvents, and made up to 100% w/v with Castor Oil, as a co-solvent and release rate modifier. structural formula

Fulvestrant injection for intramuscular administration is an estrogen receptor antagonist. The chemical name is 7-alpha-[9-(4,4,5,5,5-penta fluoropentylsulphinyl) nonyl]estra-1,3,5-(10)- triene-3,17-beta-diol. The molecular formula is C 32 H 47 F 5 O 3 S and its structural formula is: Fulvestrant is a white powder with a molecular weight of 606.77. The solution for injection is a clear, colorless to yellow, viscous liquid. Each injection contains as inactive ingredients: 10% w/v Alcohol, 10% w/v Benzyl Alcohol, and 15% w/v Benzyl Benzoate, as co-solvents, and made up to 100% w/v with Castor Oil, as a co-solvent and release rate modifier. structural formula

Gatifloxacin ophthalmic solution is a quinolone antimicrobial topical ophthalmic solution for the treatment of bacterial conjunctivitis. Its chemical name is (±)-1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-(3-methyl-1-piperazinyl)-4-oxo-3-quinolinecarboxylic acid, sesquihydrate. Its molecular formula is C 19 H 22 FN 3 O 4 · 1½H 2 O and its molecular weight is 402.42. Its chemical structure is: Gatifloxacin ophthalmic solution is a clear, pale yellow to greenish yellow, sterile, preserved aqueous solution with an osmolality of 260 to 330 mOsm/kg and a pH of 5.1 to 5.7. Gatifloxacin ophthalmic solution contains Active: gatifloxacin, anhydrous 0.5% (5 mg/mL); Inactives: benzalkonium chloride 0.005%; edetate disodium dihydrate; sodium chloride; and purified water. Gatifloxacin ophthalmic solution may contain hydrochloric acid and/or sodium hydroxide to adjust pH. Structure formula

Gentamicin Sulfate is a water-soluble antibiotic of the aminoglycoside group. Gentamicin Sulfate Ophthalmic Solution is a sterile, aqueous solution buffered to approximately pH 7 for ophthalmic use. Gentamicin is obtained from cultures of Micromonospora purpurea . It is a mixture of the sulfate salts of gentamicin C 1 , C 2 , and C 1A . All three components appear to have similar antimicrobial activities. Gentamicin sulfate occurs as white powder and is soluble in water and insoluble in alcohol. The structure is as follows: Established name: Gentamicin Sulfate Chemical name: 0-3-Deoxy-4-C-methyl-3-(methylamino)-β-L-arabinopyranosyl-(1→6)-0-[2,6-diamino-2,3,4,6-tetradeoxy-α-D-erythro-hexopyranosyl-(1→4)]-2-deoxy-D-streptamine. Ingredients: Each mL contains: Active: Gentamicin Sulfate USP (equivalent to 3 mg gentamicin). Preservative: Benzalkonium Chloride 0.1 mg (0.01%). Inactives: Dibasic Sodium Phosphate Anhydrous, Sodium Chloride, Sodium Hydroxide and/or Hydrochloric Acid (to adjust pH), Tyloxapol and Purified Water. chemicalstructure

Glatiramer acetate, the active ingredient of Glatopa, consists of the acetate salts of synthetic polypeptides, containing four naturally occurring amino acids: L-glutamic acid, L-alanine, L-tyrosine, and L-lysine with an average molar fraction of 0.141, 0.427, 0.095, and 0.338, respectively. The average molecular weight of glatiramer acetate is 5,000 – 9,000 daltons. Glatiramer acetate is identified by specific antibodies. Chemically, glatiramer acetate is designated L-glutamic acid polymer with L-alanine, L-lysine and L-tyrosine, acetate (salt). Its structural formula is: Glatopa is a clear, colorless to slightly yellow, sterile, nonpyrogenic solution for subcutaneous injection. Each 1 mL of glatiramer acetate injection solution contains 20 mg or 40 mg of glatiramer acetate and the following inactive ingredient: 40 mg of mannitol. The pH of the solutions is approximately 5.5 to 7. The biological activity of glatiramer acetate is determined by its ability to block the induction of experimental autoimmune encephalomyelitis (EAE) in mice. structural-formula

Glycopyrrolate Injection, USP is a synthetic anticholinergic agent. Each 1 mL contains: Glycopyrrolate, USP 0.2 mg Water for Injection, USP q.s. Benzyl Alcohol, NF 0.9% (preservative) pH adjusted, when necessary, with hydrochloric acid and/or sodium hydroxide. For Intramuscular (IM) or Intravenous (IV) administration. Glycopyrrolate is a quaternary ammonium salt with the following chemical name: 3[(cyclopentylhydroxyphenylacetyl)oxy]-1,1-dimethyl pyrrolidinium bromide. The molecular formula is C 19 H 28 BrNO 3 and the molecular weight is 398.33. Its structural formula is as follows: C 19 H 28 BrNO 3 MW 398.33 Glycopyrrolate occurs as a white, odorless crystalline powder. Freely soluble in water, soluble in ethanol (96%). Very slightly soluble in methylene chloride. Practically insoluble in chloroform and in ether. Unlike atropine, glycopyrrolate is completely ionized at physiological pH values. Glycopyrrolate injection, USP is a clear, colorless, sterile liquid; pH 2.0 to 3.0. The partition coefficient of glycopyrrolate in a n-octanol/water system is 0.304 (log 10 P= -1.52) at ambient room temperature (24°C). Meets Organic Impurities procedure 2. chemical-structure

Griseofulvin tablets, USP (microsize) contains griseofulvin microsize for oral administration. The active ingredient, griseofulvin, is a fungistatic antibiotic, derived from a species of Penicillium . The chemical name of griseofulvin is 7-chloro-2’,4,6-trimethoxy-6’β-methylspiro[benzofuran-2(3H),1’-[2]cyclohexane]-3-4’-dione. Its structural formula is: Molecular Formula: C 17 H 17 ClO 6 Molecular Weight: 352.77 Griseofulvin occurs as a white to creamy white, bitter tasting powder which is very slightly soluble in water and sparingly soluble in alcohol. Griseofulvin microsize contains particles of approximately 2 to 4 µm in diameter. Griseofulvin tablets, USP (microsize) are available as follows: 250 mg, white to off-white round, flat, beveled edge, scored tablets engraved with 'I27' on one side and score on the other. 500 mg, white to off-white round, flat, beveled edge, scored tablets engraved with 'I26' on one side and score on the other. Each tablet contains 250 mg or 500 mg of griseofulvin microsize, and also contains calcium stearate, colloidal silicon dioxide, corn starch, crospovidone, dibasic calcium phosphate, and sodium starch glycolate. chemical-structure

Heparin is a heterogeneous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans, having anticoagulant properties. Although others may be present, the main sugars occurring in heparin are: (1) α -L-iduronic acid 2-sulfate, (2) 2-deoxy-2-sulfamino- α -D-glucose 6-sulfate, (3) β -D-glucuronic acid, (4) 2-acetamido-2-deoxy- α -D-glucose and (5) α -L-iduronic acid. These sugars are present in decreasing amounts, usually in the order (2)> (1)> (4)> (3)> (5), and are joined by glycosidic linkages, forming polymers of varying sizes. Heparin is strongly acidic because of its content of covalently linked sulfate and carboxylic acid groups. In heparin sodium, the acidic protons of the sulfate units are partially replaced by sodium ions. Heparin Sodium Injection, USP is a sterile solution of heparin sodium derived from porcine intestinal mucosa, standardized for anticoagulant activity, in water for injection. It is to be administered by intravenous or deep subcutaneous routes. The potency is determined by a biological assay using a USP reference standard based on units of heparin activity per milligram. Structure of Heparin Sodium (representative subunits): Heparin sodium injection, USP (porcine), preservative free, is available as follows: Each mL of the 1,000 units per mL preparation contains: 1,000 USP Heparin units (porcine); 9 mg sodium chloride; Water for Injection q.s. made isotonic with sodium chloride. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment (5.0 to 7.5). Heparin sodium injection, USP (porcine), preserved with benzyl alcohol, is available as follows: Each mL of the 5,000 units per mL preparation contains: 5,000 USP Heparin units (porcine); 6 mg sodium chloride; 15 mg benzyl alcohol (as a preservative); Water for Injection q.s. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment (5.0 to 7.5). Heparin Sodium Injection, USP (porcine), preserved with parabens, is available as follows: Each mL of the 1,000 units per mL preparation contains: 1,000 USP Heparin units (porcine); 9 mg sodium chloride; 1.5 mg methylparaben; 0.15 mg propylparaben; Water for Injection q.s. made isotonic with sodium chloride. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment (5.0 to 7.5). Each mL of the 5,000 units per mL preparation contains: 5,000 USP Heparin units (porcine); 5 mg sodium chloride; 1.5 mg methylparaben; 0.15 mg propylparaben; Water for Injection q.s. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment (5.0 to 7.5). Each mL of the 10,000 units per mL preparation contains: 10,000 USP Heparin units (porcine); 1.5 mg methylparaben; 0.15 mg propylparaben; Water for Injection q.s. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment (5.0 to 7.5). Each mL of the 20,000 units per mL preparation contains: 20,000 USP Heparin units (porcine); 1.5 mg methylparaben; 0.15 mg propylparaben; Water for Injection q.s. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment (5.0 to 7.5). Heparin Chemical Structure

Topotecan is a topoisomerase inhibitor. The chemical name for topotecan hydrochloride is ( S )-10-[(dimethylamino)methyl]-4-ethyl-4,9-dihydroxy-1 H -pyrano[3',4':6,7] indolizino [1,2- b ]quinoline-3,14-(4 H ,12 H )-dione monohydrochloride. The molecular formula is C 23 H 23 N 3 O 5 •HCl and the molecular weight is 457.9 g/mol. It is soluble in water and melts with decomposition at 213°C to 218°C. Topotecan hydrochloride has the following structural formula: HYCAMTIN capsules, contain topotecan hydrochloride, the content of which is expressed as topotecan free base. Each 0.25 mg and 1 mg capsule contain topotecan hydrochloride equivalent to 0.25 mg and 1 mg topotecan free-base, respectively. The excipients are gelatin, glyceryl monostearate, hydrogenated vegetable oil, and titanium dioxide. The capsules are imprinted with edible black ink. The 1 mg capsules also contain red iron oxide. topotecan hydrochloride chemical structure

Hydroxyzine pamoate is a light yellow, practically odorless powder practically insoluble in water and methanol and freely soluble in dimethylformamide. It is chemically designated as (±)-2-[2-[4-(p-Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol 4,4’-methylenebis[3-hydroxy-2-naphthoate] (1:1) [10246-75-0] and can be structurally represented as follows: C 21 H 27 CIN 2 O 2 •C 23 H 16 O 6 M.W. 763.27 Each capsule, for oral administration, contains hydroxyzine pamoate equivalent to hydroxyzine hydrochloride 25 mg or 50 mg. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, sodium starch glycolate (potato), and sodium lauryl sulfate. The capsule shell contains the following ingredients: D&C Yellow #10, FD&C Green #3, FD&C Yellow #6, gelatin, and titanium dioxide. The edible imprinting ink contains the following ingredients: black iron oxide, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, propylene glycol, and shellac glaze. Chemical Structure

Adalimumab-adaz is a tumor necrosis factor blocker. Adalimumab-adaz is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-adaz is produced by recombinant DNA technology in a Chinese hamster ovary cell expression system and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. HYRIMOZ (adalimumab-adaz) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (Sensoready Pen) as a single-dose, prefilled 1 mL glass syringe with needle guard and add-on finger flange or as a single-dose, prefilled 1 mL glass syringe. Enclosed within the Pen is a single-dose, 1 mL prefilled glass syringe. The solution of HYRIMOZ is clear, colorless or slightly yellowish, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled Sensoready Pen or prefilled syringe with BD UltraSafe Passive TM Needle Guard delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of HYRIMOZ contains adalimumab-adaz (80 mg), adipic acid (1.75 mg), mannitol (33.6 mg), polysorbate 80 (0.32 mg), and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 40 mg/0.4 mL prefilled Sensoready Pen or prefilled syringe with BD UltraSafe Passive TM Needle Guard delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of HYRIMOZ contains adalimumab-adaz (40 mg), adipic acid (0.88 mg), mannitol (16.8 mg), polysorbate 80 (0.16 mg) and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 40 mg/0.8 mL prefilled Sensoready Pen or prefilled syringe with BD UltraSafe Passive TM Needle Guard delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of HYRIMOZ contains adalimumab-adaz (40 mg), adipic acid (2.69 mg), citric acid monohydrate (0.206 mg), mannitol (9.6 mg), polysorbate 80 (0.8 mg), sodium chloride (4.93 mg), and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 20 mg/0.4 mL prefilled syringe with BD UltraSafe Passive TM Needle Guard delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of HYRIMOZ contains adalimumab-adaz (20 mg), adipic acid (1.34 mg), citric acid monohydrate (0.103 mg), mannitol (4.8 mg), polysorbate 80 (0.4 mg), sodium chloride (2.46 mg), and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of HYRIMOZ contains adalimumab-adaz (20 mg), adipic acid (0.44 mg), mannitol (8.4 mg), polysorbate 80 (0.08 mg) and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH. Each 10 mg/0.1 mL prefilled syringe delivers 0.1 mL (10 mg) of drug product. Each 0.1 mL of HYRIMOZ contains adalimumab-adaz (10 mg), adipic acid (0.22 mg), mannitol (4.2 mg), polysorbate 80 (0.04 mg) and Water for Injection, USP. Hydrochloric acid and sodium hydroxide are added as necessary to adjust pH.

INFUVITE ADULT (multiple vitamins injection) is a sterile product consisting of two vials provided as a single dose or as a pharmacy bulk package, both intended for intravenous use for administration by intravenous infusion after dilution: INFUVITE ADULT Single Dose - two 5 mL single-dose vials labeled Vial 1 and Vial 2. INFUVITE ADULT Pharmacy Bulk Package - two vials – 1 each of Vial 1 (50 mL) and Vial 2 (50 mL Fill in 100 mL Vial). The mixed solution (100 mL) will provide ten 10 mL single doses. Each 5 mL of Vial 1 contains: Ascorbic acid (Vitamin C) 200 mg Vitamin A * (as palmitate) 3,300 IU Vitamin D 3 * (cholecalciferol) 200 IU Thiamine (Vitamin B 1 ) (as the hydrochloride) 6 mg Riboflavin (Vitamin B 2 ) (as riboflavin 5-phosphate sodium) 3.6 mg Pyridoxine HCl (Vitamin B 6 ) 6 mg Niacinamide 40 mg Dexpanthenol (as d -pantothenyl alcohol) 15 mg Vitamin E * ( dl -α-tocopheryl acetate) 10 IU Vitamin K 1 * 150 mcg *Polysorbate 80 is used to water solubilize the oil-soluble vitamins A, D, E, and K. Inactive ingredients: 1.4% polysorbate 80, sodium hydroxide and/or hydrochloric acid for pH adjustment, and water for injection. Each 5 mL of Vial 2 contains: Folic acid 600 mcg Biotin 60 mcg Vitamin B 12 (cyanocobalamin) 5 mcg Inactive ingredients: 30% propylene glycol, citric acid and/or sodium citrate for pH adjustment, and water for injection. INFUVITE ADULT makes available a combination of important oil-soluble and water-soluble vitamins in an aqueous solution, formulated for incorporation into intravenous solutions. The liposoluble vitamins A, D, E, and K have been solubilized in an aqueous medium with polysorbate 80, permitting intravenous administration of these vitamins. Contains no more than 70 mcg/L of aluminum (combined Vials 1 and 2).

INFUVITE PEDIATRIC (multiple vitamins injection) is a sterile product consisting of two vials provided as a single dose or as a pharmacy bulk package for intravenous use intended for administration by intravenous infusion after dilution: INFUVITE PEDIATRIC (multiple vitamins injection) supplied as single dose consists of: (a) Vial 1 (4 mL); and (b) Vial 2 (1 mL). Vial 1 will provide one daily dose of 1.2 mL, 2.6 mL or 4 mL and Vial 2 will provide one daily dose of 0.3 mL, 0.65 mL or 1 mL [see Dosage and Administration ( 2.2 )]. INFUVITE PEDIATRIC (multiple vitamins injection) supplied as pharmacy bulk package consists of: (a) Vial 1 (40 mL Fill in 50 mL Vial); and (b) Vial 2 (10 mL). The mixed solution will provide many single doses [see Dosage and Administration ( 2.2 )] . Each 4 mL of Vial 1 contains 10 vitamins and each 1 mL of Vial 2 contains 3 vitamins (see Table 3 ). Table 3: Ingredients In INFUVITE Pediatric Formulation Vial 1 Active Ingredient Quantity per 4 mL Ascorbic acid (Vitamin C) 80 mg Vitamin A * (as palmitate) 2,300 IU (equals 0.7 mg) Vitamin D 3 * (cholecalciferol) 400 IU (equals 10 mcg) Thiamine (Vitamin B 1 ) (as the hydrochloride) 1.2 mg Riboflavin (Vitamin B 2 ) (as riboflavin 5-phosphate sodium) 1.4 mg Pyridoxine HCl (Vitamin B 6 ) 1 mg Niacinamide 17 mg Dexpanthenol (as d -pantothenyl alcohol) 5 mg Vitamin E * ( dl -α-tocopheryl acetate) 7 IU (equals 7 mg) Vitamin K 1 * 0.2 mg *Polysorbate 80 is used to water solubilize the oil-soluble vitamins A, D, E, and K. Inactive ingredients in 4 mL of Vial 1: 50 mg polysorbate 80, sodium hydroxide and/or hydrochloric acid for pH adjustment, and water for injection. Vial 2 Active Ingredient Quantity per 1 mL Folic acid 140 mcg Biotin 20 mcg Vitamin B 12 (cyanocobalamin) 1 mcg Inactive ingredients in 1 mL of Vial 2: 75 mg mannitol, citric acid and/or sodium citrate for pH adjustment and water for injection. INFUVITE PEDIATRIC (multiple vitamins injection) makes available a combination of oil-soluble and water-soluble vitamins in an aqueous solution, formulated for incorporation into intravenous solutions. The liposoluble vitamins A, D, E, and K have been solubilized in an aqueous medium with polysorbate 80, permitting intravenous administration of these vitamins. INFUVITE PEDIATRIC contains no more than 30 mcg/L of aluminum (combined Vials 1 and 2).

Iron sucrose injection, USP, an iron replacement product, is a brown, sterile, aqueous, complex of polynuclear iron (III)-hydroxide in sucrose for intravenous use. Iron sucrose injection has a molecular weight of approximately 34,000 to 60,000 daltons and a proposed structural formula: [Na 2 Fe 5 O 8 (OH) ·3(H 2 O)] n ·m(C 12 H 22 O 11 ) where: n is the degree of iron polymerization and m is the number of sucrose molecules associated with the iron (III)-hydroxide. Each mL contains 20 mg elemental iron as iron sucrose in water for injection. Iron sucrose injection is available in 10 mL single-dose vials (200 mg elemental iron per 10 mL), 5 mL single-dose vials (100 mg elemental iron per 5 mL), and 2.5 mL single-dose vials (50 mg elemental iron per 2.5 mL). The drug product contains approximately 30% sucrose w/v (300 mg/mL) and sodium chloride for tonicity. Sodium hydroxide may be added to adjust pH to 10.5 to 11.1. The product contains no preservatives. The osmolarity of the injection is 1,250 mOsmol/L.

Isoniazid is the hydrazide of isonicotinic acid. Isoniazid Injection USP provides 100 mg isoniazid per mL with 0.25% chlorobutanol (chloral derivative) as a preservative; the pH has been adjusted to 6 to 7 with sodium hydroxide or hydrochloric acid. At the time of manufacture, the air in the container is replaced by nitrogen. Isoniazid is chemically known as isonicotinyl hydrazine or isonicotinic acid hydrazide. It has an empirical formula of C 6 H 7 N 3 O and a molecular weight of 137.14. It has the following structure: Isoniazid is odorless, and occurs as a colorless or white crystalline powder or as white crystals. It is freely soluble in water, sparingly soluble in alcohol, and slightly soluble in chloroform and in ether. Isoniazid is slowly affected by exposure to air and light. isoniazid-chemical-structure

Rx Only DESCRIPTION Isosorbide dinitrate (ISDN) is 1,4:3,6-dianhydro-D-glucitol 2,5-dinitrate, an organic nitrate whose structural formula is: The organic nitrates are vasodilators, active on both arteries and veins. Isosorbide dinitrate is a white, crystalline, odorless compound which is stable in air and in solution, has a melting point of 70°C and has an optical rotation of +134° (c=1, alcohol, 20°C). Isosorbide dinitrate is freely soluble in organic solvents such as acetone, alcohol, and ether, but is only sparingly soluble in water. Isosorbide dinitrate is available as 5 mg, 10 mg, and 20 mg tablets for oral administration. Inactive ingredients: lactose (monohydrate), magnesium stearate, microcrystalline cellulose. The 5 mg also contains FD & C Red #40 Aluminum Lake. The 20 mg also contains D & C Yellow #10 Aluminum Lake, FD & C Blue #1 Aluminum Lake, and FD & C Yellow #6 Aluminum Lake. Chemical-Structure

Denosumab-bbdz is a human IgG2 monoclonal antibody with affinity and specificity for human RANKL (receptor activator of nuclear factor kappa-B ligand). Denosumab-bbdz has an approximate molecular weight of 147 kDa and is produced in genetically engineered mammalian (Chinese hamster ovary) cells. Jubbonti (denosumab-bbdz) injection is a sterile, preservative-free, clear to slightly opalescent and colorless to slightly yellowish to slightly brownish solution for subcutaneous use. Each single-dose prefilled syringe contains 1 mL solution of 60 mg denosumab-bbdz, glacial acetic acid (1.021 mg), polysorbate 20 (0.1 mg), sodium hydroxide (0.499 mg), sorbitol (47 mg), and Water for Injection (USP). Hydrochloric acid and sodium hydroxide may be added to adjust the pH to 5.2.

Ketorolac tromethamine ophthalmic solution 0.5% is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs) for topical ophthalmic use. Its chemical name is (±)-5-Benzoyl-2,3-dihydro-1 H -pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1) and it has the following structure: Ketorolac tromethamine ophthalmic solution is supplied as a sterile isotonic aqueous 0.5% solution, with a pH of 7.4. Ketorolac tromethamine ophthalmic solution contains a racemic mixture of R-(+) and S-(-)- ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. The pKa of ketorolac is 3.5. This white to off-white crystalline substance discolors on prolonged exposure to light. The molecular weight of ketorolac tromethamine is 376.41. The osmolality of ketorolac tromethamine ophthalmic solution is 290 mOsmol/kg. Each mL of ketorolac tromethamine ophthalmic solution contains: Active: ketorolac tromethamine 0.5%. Preservative: benzalkonium chloride 0.01%. Inactives: edetate disodium 0.1%; octoxynol 40; purified water; sodium chloride; hydrochloric acid and/or sodium hydroxide to adjust the pH. chemicalstructure

Latanoprost is a prostaglandin F 2α analogue. Its chemical name is isopropyl-(Z)-7[(1R,2R,3R,5S)3,5-dihydroxy-2-[(3R)-3-hydroxy-5-phenylpentyl]cyclopentyl]-5-heptenoate. Its molecular formula is C 26 H 40 O 5 and its chemical structure is: Latanoprost is a colorless to slightly yellow oil that is very soluble in acetonitrile and freely soluble in acetone, ethanol, ethyl acetate, isopropanol, methanol and octanol. It is practically insoluble in water. Latanoprost ophthalmic solution 0.005% is supplied as a sterile, isotonic, buffered aqueous solution of latanoprost with a pH of approximately 6.7 and an osmolality of approximately 267 mOsmol/kg. Each mL of latanoprost ophthalmic solution contains 50 mcg of latanoprost. Benzalkonium chloride, 0.02% is added as a preservative. The inactive ingredients are: sodium chloride, monobasic sodium phosphate monohydrate, dibasic sodium phosphate anhydrous and water for injection. One drop contains approximately 1.5 mcg of latanoprost. chemicalstructure

Fluvastatin sodium inhibits 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Fluvastatin sodium is [ R *, S *-( E )]-(±)-7-[3-(4-fluorophenyl)-1-(1-methylethyl)-1 H -indol-2-yl]-3,5-dihydroxy-6-heptenoic acid, monosodium salt. The empirical formula of fluvastatin sodium is C 24 H 25 FNO 4 •Na, its molecular weight is 433.46 g/mol and its structural formula is: Fluvastatin sodium is a white to pale yellow, hygroscopic powder soluble in water, ethanol and methanol. LESCOL XL is supplied as extended-release tablets containing 84.24 mg of fluvastatin sodium, equivalent to 80 mg of fluvastatin, for oral use. LESCOL XL tablets contain the following inactive ingredients: hydroxypropyl cellulose, hydroxypropyl methyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 8000, potassium bicarbonate, povidone, titanium dioxide, and yellow iron oxide. Fluvastatin sodium structural formula

Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin releasing hormone (GnRH or LH-RH). The analog possesses greater potency than the natural hormone. The chemical name is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate (salt) with the following structural formula: Leuprolide acetate injection is a sterile, aqueous solution intended for subcutaneous injection. It is available in a 2.8 mL multiple-dose vial containing leuprolide acetate (5 mg/mL), sodium chloride, USP (6.3 mg/mL) for tonicity adjustment, benzyl alcohol, NF as a preservative (9 mg/mL), and water for injection, USP. The pH may have been adjusted with sodium hydroxide, NF and/or acetic acid, NF. The pH range is 4.0 to 6.0. Leuprolide Acetate Chemical Structure

Linezolid intravenous injection contains linezolid, which is a synthetic antibacterial agent of the oxazolidinone class. The chemical name for linezolid is (S)-N-[[3-[3-Fluoro-4-(4-morpholinyl)phenyl]-2-oxo-5-oxazolidinyl] methyl]-acetamide. The molecular formula is C 16 H 20 FN 3 O 4 . Its molecular weight is 337.35, and its chemical structure is represented below: Linezolid intravenous injection is supplied as a ready-to-use sterile isotonic solution for intravenous infusion. Each mL contains 2 mg of linezolid. Inactive ingredients are citric acid anhydrous, dextrose in an aqueous vehicle for intravenous administration, and sodium citrate. The sodium (Na + ) content is 0.38 mg/mL (5 mEq/300-mL bag and 1.7 mEq/100-mL bag). The pH has been adjusted with sodium hydroxide and/or hydrochloric acid. structure

Lisdexamfetamine dimesylate, a CNS stimulant, is a capsule for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino- N -[(1 S )-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C 15 H 25 N 3 O•(CH 4 O 3 S) 2 , which corresponds to a molecular weight of 455.60. The chemical structure is: Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine) and the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose (Avicel PH 102), povidone K29/32. In addition the 10 mg hard gelatin capsules contain: Iron red oxide, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 20 mg hard gelatin capsules contain: FD&C yellow No. 5, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 30 mg hard gelatin capsules contain: FD&C yellow No. 6, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 40 mg hard gelatin capsules contain: FD&C blue No. 1, FD & C yellow No. 5, FD&C yellow No. 6, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 50 mg hard gelatin capsules contain: FD&C blue No. 1, FD&C red No. 3, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 60 mg hard gelatin capsules contain: FD&C blue No. 1, FD&C red No. 3, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 70 mg hard gelatin capsules contain: FD&C red No. 40, FD&C yellow No. 6, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. Opacode black S-1-8114 consists of: shellac glaze, iron oxide black, N-Butyl alcohol, propylene glycol, FD&C blue No. 2/Indigo carmine aluminum lake, FD&C red No. 40/Allura red AC aluminum lake, FD&C blue No. 1/Brilliant blue FCF aluminum lake, and D&C yellow No. 10 aluminum lake. Opacode black S-1-8115 consists of: shellac glaze, iron oxide black, SDA 3A alcohol, FD&C blue No. 2/Indigo carmine aluminum lake, FD&C red No. 40/Allura red AC aluminum lake, FD&C blue No. 1/Brilliant blue FCF aluminum lake, and D&C yellow No. 10 aluminum lake. chemicalstructure

MAXITROL ® (neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment) is a multiple dose anti-infective steroid combination in sterile ointment form for topical application. The chemical structure for the active ingredient Neomycin Sulfate is: Neomycin B (R 1 =H, R 2 =CH 2 NH 2 ) Neomycin C (R 1 =CH 2 NH 2 , R 2 =H) The chemical structure for the active ingredient Polymyxin B Sulfate is: The chemical structure for the active ingredient dexamethasone is: C 22 H 29 FO 5 Molecular Weight = 392.47 g/mol Established name: dexamethasone Chemical name: pregna-1, 4-diene-3, 20-dione,9-fluoro-11,17, 21-trihydroxy-16-methyl-, (11β, 16α)-. Each gram of MAXITROL ® (neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment) contains: Active: neomycin sulfate equivalent to neomycin 3.5 mg, polymyxin B sulfate 10,000 units, dexamethasone 0.1%. Inactives: anhydrous liquid lanolin and white petrolatum. Preservatives: methylparaben 0.05%, propylparaben 0.01%. The chemical structure for the active ingredient Neomycin Sulfate The chemical structure for the active ingredient Polymyxin B Sulfate polymyxin-text The chemical structure for the active ingredient Dexamethasone

Meropenem for injection is a sterile, pyrogen-free, synthetic, carbapenem antibacterial for intravenous administration. It is (4R,5S,6S)-3- [[(3S,5S)-5-(Dimethylcarbamoyl)-3-pyrrolidinyl]thio]-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxilic acid trihydrate. Its empirical formula is C 17 H 25 N 3 O 5 S∙3H 2 O with a molecular weight of 437.52. Its structural formula is: Meropenem for injection is a white to pale yellow crystalline powder. The solution varies from colorless to yellow depending on the concentration. The pH of freshly constituted solutions is between 7.3 and 8.3. Meropenem is soluble in 5% monobasic potassium phosphate solution, sparingly soluble in water, very slightly soluble in hydrated ethanol, and practically insoluble in acetone or ether. When re-constituted as instructed, each 1 gram meropenem for injection vial will deliver 1 gram of meropenem and 90.2 mg of sodium as sodium carbonate (3.92 mEq). Each 500 mg meropenem for injection vial will deliver 500 mg meropenem and 45.1 mg of sodium as sodium carbonate (1.96 mEq) [ see Dosage and Administration (2.4) ] . Chemical Structure

Methylprednisolone acetate injectable suspension, USP is a sterile anti-inflammatory glucocorticoid for intramuscular, intra-articular, soft tissue, or intralesional injection. It is available in 40 mg/mL, 80 mg/mL strength: Each mL of these preparations contains: Methylprednisolone acetate.................................. 40 mg 80 mg Polyethylene glycol 3350................................... 29.1 mg 28.2 mg Polysorbate 80.................................................... 1.94 mg 1.88 mg Monobasic sodium phosphate monohydrate........ 6.8 mg 6.59 mg Dibasic sodium phosphate anhydrous USP........ 1.42 mg 1.37 mg Benzyl alcohol added as a preservative............... 9.16 mg 8.88 mg Sodium Chloride was added to adjust tonicity. When necessary, pH was adjusted with sodium hydroxide and/or hydrochloric acid. The pH of the finished product remains within the USP specified range (e.g., 3.5 to 7.0). The chemical name for methylprednisolone acetate is pregna-1,4-diene-3,20- dione, 21-(acetyloxy)-11,17-dihydroxy-6-methyl-,(6α,11β) and 11β,17,21-Trihydroxy-6α-methylpregna-1,4-diene-3,20-dione 21-acetate the molecular weight is 416.51. The structural formula is represented below: Methylprednisolone acetate sterile aqueous suspension contains methylprednisolone acetate which is the 6-methyl derivative of prednisolone. Methylprednisolone acetate is a white or practically white, odorless, crystalline powder which melts at about 215° with some decomposition. It is soluble in dioxane, sparingly soluble in acetone, alcohol, chloroform, and methanol, and slightly soluble in ether. It is practically insoluble in water. MPA Structure

Metolazone Tablets, USP for oral administration contain 2.5 mg, 5 mg or 10 mg of metolazone USP, a diuretic/saluretic/antihypertensive drug of the quinazoline class. Metolazone has the molecular formula C 16 H 16 ClN 3 O 3 S, the chemical name 7-chloro-1,2,3,4-tetrahydro-2-methyl-4-oxo-3- o -tolyl-6-quinazolinesulfonamide, and a molecular weight of 365.84. The structural formula is: Metolazone is only sparingly soluble in water, but more soluble in plasma, blood, alkali, and organic solvents. Inactive Ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose and dye: 2.5 mg - D&C red No. 30 and FD&C blue No. 2; 5 mg - FD&C blue No. 2; 10 mg - D&C yellow No. 10 and FD&C yellow No. 6. Chemical-Structure

Moxifloxacin ophthalmic solution 0.5% is a sterile solution for topical ophthalmic use. Moxifloxacin hydrochloride is an 8-methoxy fluoroquinolone anti-infective, with a diazabicyclononyl ring at the C7 position. The chemical name for moxifloxacin hydrochloride is 1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy- 7-[(4aS,7aS)-octahydro-6H-pyrrolol[3,4b]pyridin-6-yl]-4-oxo- 3-quinolinecarboxylic acid, monohydrochloride. The molecular formula for moxifloxacin hydrochloride is C 21 H 24 FN 3 O 4 •HCl and its molecular weight is 437.9 g/mol. The chemical structure is presented below: Moxifloxacin hydrochloride is a slightly yellow to yellow crystalline powder. Each mL of moxifloxacin ophthalmic solution contains 5.45 mg moxifloxacin hydrochloride, equivalent to 5 mg moxifloxacin base. Moxifloxacin ophthalmic solution contains Active: Moxifloxacin 0.5% (5 mg/mL); Inactives: Boric acid, purified water, and sodium chloride. May also contain hydrochloric acid/sodium hydroxide to adjust pH to approximately 6.8. Moxifloxacin ophthalmic solution is an isotonic solution with an osmolality of approximately 290 mOsm/kg. chemical

Mycophenolate mofetil is an antimetabolite immunosuppressant. It is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor. The chemical name for mycophenolate mofetil (MMF) is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate. It has a molecular formula of C 23 H 31 NO 7 , a molecular weight of 433.50, and the following structural formula: Mycophenolate mofetil is a white to off-white crystalline powder. It is slightly soluble in water (43 mcg/mL at pH 7.4); the solubility increases in acidic medium (4.27 mg/mL at pH 3.6). It is freely soluble in acetone, soluble in methanol, and sparingly soluble in ethanol. The apparent partition coefficient in 1-octanol/water (pH 7.4) buffer solution is 238. The pKa values for mycophenolate mofetil are 5.6 for the morpholino group and 8.5 for the phenolic group. Inactive Ingredients: Tablets - Mycophenolate mofetil tablets are available for oral administration as tablets containing 500 mg of mycophenolate mofetil. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone, talc, hypromellose, hydroxypropyl cellulose, polyethylene glycol, titanium dioxide, iron oxide black and iron oxide red. Capsules - Mycophenolate mofetil capsules, USP are available for oral administration as capsules containing 250 mg of mycophenolate mofetil. In addition, each capsule contains the following inactive ingredients: croscarmellose sodium, FD&C blue #2, gelatin, magnesium stearate, povidone (K-90), pregelatinized starch and titanium dioxide. The capsule is printed with edible black ink. The black ink is comprised of butyl alcohol, black iron oxide, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution. Structure

Neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment is a multiple dose anti-infective steroid combination in sterile ointment form for topical application. The chemical structure for the active ingredient Neomycin Sulfate is: Neomycin B (R 1 =H, R 2 =CH 2 NH 2 ) Neomycin C (R 1 =CH 2 NH 2 , R 2 =H) The chemical structure for the active ingredient Polymyxin B Sulfate is: The chemical structure for the active ingredient Dexamethasone is: C 22 H 29 FO 5 Molecular Weight = 392.47 g/mol Established name: dexamethasone Chemical name: pregna-1, 4-diene-3, 20-dione,9-fluoro-11,17, 21-trihydroxy-16-methyl-, (11β, 16α)-. Each gram of neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment contains: Active: neomycin sulfate equivalent to neomycin 3.5 mg, polymyxin B sulfate 10,000 units, dexamethasone 0.1%. Preservatives: methylparaben 0.05%, propylparaben 0.01%. Inactives: anhydrous liquid lanolin and white petrolatum. neomycin-chemical polymyxin-chemical polymyxin-text dexamethasone-chemical

Neomycin and polymyxin B sulfates and dexamethasone ophthalmic suspension is a multiple dose anti-infective steroid combination in sterile suspension form for topical application. The chemical structure for the active ingredient, dexamethasone, is: MW = 392.45 C 22 H 29 FO 5 Established name: dexamethasone Chemical name: pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 17, 21-trihydroxy-16-methyl-, (11β, 16α)-. The other active ingredients are neomycin sulfate and polymyxin B sulfate. The structural formula for neomycin sulfate is: Neomycin B (R 1 =H, R 2 =CH 2 NH 2 ) Neomycin C (R 1 =CH 2 NH 2 , R 2 =H) The structural formula for polymyxin B sulfate is: Each mL of Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension contains: Actives: neomycin sulfate equivalent to neomycin 3.5 mg, polymyxin B sulfate 10,000 units, dexamethasone 0.1%. Inactives: hypromellose 2910 0.5%, sodium chloride, polysorbate 20, hydrochloric acid and/or sodium hydroxide (to adjust pH), purified water, benzalkonium chloride 0.004% (preservative). dexamethasone-chemical neomycin-chemical polymyxin-chemical

Neomycin and Polymyxin B Sulfates and Hydrocortisone OTIC Solution, USP is a sterile antibacterial and anti-inflammatory solution for otic use. Each mL contains: Active ingredients: neomycin sulfate equivalent to 3.5 mg neomycin base, polymyxin B sulfate equivalent to 10,000 polymyxin B units, and hydrocortisone 10 mg (1%). Inactive ingredients: glycerin, hydrochloric acid, potassium metabisulfite 0.1% (added as a preservative), propylene glycol, and water for injection. Neomycin sulfate is the sulfate salt of neomycin B and C, which are produced by the growth of Streptomyces fradiae Waksman (Fam. Streptomycetaceae). It has a potency equivalent of not less than 600 mcg of neomycin standard per mg, calculated on an anhydrous basis. The structural formulae are: Neomycin B (R 1 =H, R 2 =CH 2 NH 2 ) Neomycin C (R 1 =CH 2 NH 2 , R 2 =H) Polymyxin B sulfate is the sulfate salt of polymyxin B 1 and B 2 , which are produced by the growth of Bacillus polymyxa (Prazmowski) Migula (Fam. Bacillaceae). It has a potency of not less than 6,000 polymyxin B units per mg, calculated on an anhydrous basis. The structural formulae are: Hydrocortisone, 11β,17,21-trihydroxypregn-4-ene-3, 20-dione, is an anti-inflammatory hormone. Its structural formula is: structure1 structure2 polymyxin hydrocortisone

Neomycin and Polymyxin B Sulfates and Hydrocortisone OTIC Suspension, USP is a sterile antibacterial and anti-inflammatory suspension for otic use. Each mL contains: neomycin sulfate equivalent to 3.5 mg neomycin base, polymyxin B sulfate equivalent to 10,000 polymyxin B units, and hydrocortisone 10 mg (1%). The vehicle contains thimerosal 0.01% (added as a preservative) and the inactive ingredients cetyl alcohol, propylene glycol, polysorbate 80, glacial acetic acid and Water for Injection. Neomycin sulfate is the sulfate salt of neomycin B and C, which are produced by the growth of Streptomyces fradiae Waksman (Fam. Streptomycetaceae). It has a potency equivalent of not less than 600 mcg of neomycin standard per mg, calculated on an anhydrous basis. The structural formula are: Neomycin B (R 1 =H, R 2 =CH 2 NH 2 ) Neomycin C (R 1 =CH 2 NH 2 , R 2 =H) Polymyxin B sulfate is the sulfate salt of polymyxin B 1 and B 2 , which are produced by the growth of Bacillus polymyxa (Prazmowski) Migula (Fam. Bacillaceae). It has a potency of not less than 6,000 polymyxin B units per mg, calculated on an anhydrous basis. The structural formula are: Hydrocortisone, 11β,17, 21-trihydroxypregn-4-ene-3, 20-dione, is an anti-inflammatory hormone. Its structural formula is: neomycin polymyxin polymyxin-text hydrocortisone-chemical

Neomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension is a sterile antimicrobial and anti-inflammatory suspension for ophthalmic use. Each mL contains: Actives: neomycin sulfate (equivalent to 3.5 mg neomycin base), polymyxin B sulfate equivalent to 10,000 polymyxin B units, and hydrocortisone 10 mg (1%). Preservative: thimerosal 0.001%. Inactives: cetyl alcohol, glyceryl monostearate, mineral oil, polyoxyl 40 stearate, propylene glycol, sulfuric acid (to adjust pH) and water for injection. Neomycin sulfate is the sulfate salt of neomycin B and C, which are produced by the growth of Streptomyces fradiae Waksman (Fam. Streptomycetacae). It has a potency equivalent to not less than 600 μg of neomycin standard per mg, calculated on an anhydrous basis. Its structural formula are: Neomycin B (R 1 =H, R 2 =CH 2 NH 2 ) Neomycin C (R 1 =CH 2 NH 2 , R 2 =H) Polymyxin B sulfate is the sulfate salt of Polymyxin, B1 and B2, which are produced by the growth of Bacillus polymyxa (Prazmowski) Migula (Fam. Bacillaceae). It has a potency of not less than 6,000 polymyxin B units per mg calculated on an anhydrous basis. Its structural formula are: Hydrocortisone, 11β, 17, 21-trihydroxypregn-4-ene-3, 20 dione, is an anti-inflammatory hormone. Its structural formula is: neomycin polymyxin name hydrocortisone-chemical

Nitrofurantoin is an antibacterial agent specific for urinary tract infections. Nitrofurantoin capsules, USP (monohydrate/macrocrystals) are hard gelatin capsule shells containing the equivalent of 100 mg of nitrofurantoin in the form of 25 mg of nitrofurantoin macrocrystals USP and 75 mg of nitrofurantoin monohydrate USP. The chemical name of nitrofurantoin macrocrystals USP is 1-[[[5-nitro-2-furanyl]methylene]amino]-2,4-imidazolidinedione. The chemical structure is the following: Molecular Weight: 238.16 The chemical name of nitrofurantoin monohydrate USP is 1-[[[5-nitro-2-furanyl]methylene]amino]-2,4-imidazolidinedione monohydrate. The chemical structure is the following: Molecular Weight: 256.17 Inactive Ingredients Each capsule contains carbomer 934P, colloidal silicon dioxide, corn starch, compressible sugar, D&C yellow No. 10, edible white ink, FD&C blue No. 1, FD&C red No. 40, gelatin, lactose monohydrate, magnesium stearate, povidone, talc, and titanium dioxide. Meets USP Dissolution Test 5 Chemical Structure 1 Chemical Structure 2

Norepinephrine (sometimes referred to as l-arterenol/Levarterenol or l-norepinephrine ) is a sympathomimetic amine which differs from epinephrine by the absence of a methyl group on the nitrogen atom. Norepinephrine bitartrate is (-)-α-(aminomethyl)-3,4-dihydroxybenzyl alcohol tartrate (1:1) (salt) monohydrate (molecular weight 337.3 g/mol) and has the following structural formula: Norepinephrine bitartrate injection, USP is supplied in a sterile aqueous solution in the form of the bitartrate salt to be administered by intravenous infusion following dilution. Norepinephrine is sparingly soluble in water, very slightly soluble in alcohol and ether, and readily soluble in acids. Each mL contains the equivalent of 1 mg base of norepinephrine, sodium chloride for isotonicity, and not more than 0.2 mg of sodium metabisulfite as an antioxidant. It has a pH of 3 to 4.5. The air in the vials has been displaced by nitrogen gas. chemical-structure

Olanzapine is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10 H -thieno[2,3- b ] [1,5]benzodiazepine. The molecular formula is C 17 H 20 N 4 S, which corresponds to a molecular weight of 312.44. The chemical structure is: Olanzapine is a yellow crystalline solid, which is practically insoluble in water. Olanzapine for injection is intended for intramuscular use only. Each single-dose vial provides for the administration of 10 mg (32 μmol) olanzapine with inactive ingredients 50 mg lactose monohydrate and 3.5 mg tartaric acid. Hydrochloric acid and/or sodium hydroxide may have been added during manufacturing to adjust pH. Structure

Olanzapine is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10 H -thieno[2,3- b ] [1,5]benzodiazepine. The molecular formula is C 17 H 20 N 4 S, which corresponds to a molecular weight of 312.44. The chemical structure is: Olanzapine is a yellow crystalline solid, which is practically insoluble in water. Olanzapine for injection is intended for intramuscular use only. Each single-dose vial provides for the administration of 10 mg (32 μmol) olanzapine with inactive ingredients 50 mg lactose monohydrate and 3.5 mg tartaric acid. Hydrochloric acid and/or sodium hydroxide may have been added during manufacturing to adjust pH. Structure

Somatropin is a human growth hormone (GH) produced by recombinant DNA technology using Escherichia coli. The protein is comprised of 191 amino acid residues and a molecular weight of approximately 22,125 daltons. The amino acid sequence is identical to that of human GH of pituitary origin. OMNITROPE (somatropin) injection is a clear, colorless, sterile solution for subcutaneous injection supplied in a cartridge for use with OMNITROPE Pen delivery system. Sodium hydroxide and/or phosphoric acid may be added during manufacture to adjust pH. OMNITROPE (somatropin) for injection is a white to off-white lyophilized powder supplied in a vial for subcutaneous injection after reconstitution. Sodium hydroxide and/or hydrochloric acid may be added during manufacture to adjust pH. Vials are co-packaged with accompanying 1.14 mL vials of a diluent containing Bacteriostatic Water for Injection with 1.5% benzyl alcohol as a preservative. After reconstitution, the concentration is 5 mg/mL. Each OMNITROPE cartridge or vial contains the following (see Table 4 ): Table 4. Contents of OMNITROPE Cartridges and Vial Product Cartridge 5 mg/ 1.5 mL Cartridge 10 mg/ 1.5 mL For Injection 5.8 mg/ vial Component Somatropin 5 mg 10 mg 5.8 mg Dibasic sodium phosphate 0.609 mg 0.71 mg 0.996 mg Monobasic sodium phosphate 1.28 mg 1.2 mg 0.52 mg Poloxamer 3 mg 3 mg - Mannitol 52.5 mg - - Glycine - 27.75 mg 27.6 mg Benzyl alcohol 13.5 mg - - Phenol - 4.5 mg - Water for Injection to make 1.5 mL to make 1.5 mL - Diluent (vials only) Bacteriostatic Water for Injection Water for injection to make 1.14 mL Benzyl alcohol 17 mg

Orphenadrine citrate, USP is the citrate salt of orphenadrine (2-dimethyl-aminoethyl 2-methylbenzhydryl ether citrate). It occurs as a white, crystalline powder having a bitter taste. It is practically odorless; sparingly soluble in water, slightly soluble in alcohol and has a molecular weight of 461.51. The molecular formula C 18 H 23 NO • C 6 H 8 O 7 is represented by the following structural formula: Each orphenadrine citrate extended-release tablet, USP contains 100 mg orphenadrine citrate, USP. Orphenadrine citrate extended-release tablets, USP also contain: calcium stearate, ethylcellulose and lactose monohydrate. Image-01