leading pharma, llc - Medication Listings

Metformin hydrochloride extended-release tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N -dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below: Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C 4 H 11 N 5 • HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pK a of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride extended-release tablets, USP contains 500 mg of metformin hydrochloride, which is equivalent to 389.93 mg metformin base. Metformin hydrochloride extended-release tablets USP, 500 mg contain the inactive ingredients carboxymethylcellulose sodium, hypromellose and magnesium stearate. Metformin Hydrochloride Extended-Release Tablets, USP meets USP Dissolution Test 3. Formula

Hydrochlorothiazide USP is a diuretic and antihypertensive. It is the 3,4-dihydro derivative of chlorothiazide. It is chemically designated as 6-chloro-3,4-dihydro-2 H -1,2,4-benzothiadiazine -7-sulfonamide 1,1-dioxide and has the following structural formula: Hydrochlorothiazide USP is a white, or practically white, crystalline powder which is slightly soluble in water, freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol, insoluble in ether, in chloroform, and in dilute mineral acids. Each tablet for oral administration contains 12.5 mg, 25 mg and 50 mg of hydrochlorothiazide USP respectively. In addition, each tablet contains the following inactive ingredients: FD&C yellow #6, lactose anhydrous, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and stearic acid. Chem Structure

Furosemide tablets are a diuretic which is an anthranilic acid derivative. Furosemide tablets for oral administration contain furosemide as the active ingredient and the following inactive ingredients: corn starch, lactose anhydrous, magnesium stearate, pregelatinized starch, microcrystalline cellulose, sodium starch glycolate, and colloidal silicon dioxide. Chemically, it is 4-chloro-N-furfuryl- 5-sulfamoylanthranilic acid. Furosemide tablets are available as white tablets for oral administration in dosage strengths of 20, 40 and 80 mg. Furosemide is a white to off-white odorless crystalline powder. It is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids. The CAS Registry Number is 54-31-9. The structural formula is as follows: furosemide structure

Each scored round, uncoated, oxybutynin chloride tablet contains 5 mg of oxybutynin chloride, USP. Chemically, oxybutynin chloride is 4(diethylamino-but-2-ynyl (RS) 2-cyclohexyl-2-hydroxy 2 phenyl acetate hydrochloride. The empirical formula of oxybutynin chloride is C 22 H 31 NO 3 •HCl. The structural formula appears below: Oxybutynin Chloride is a white crystalline, practically odorless powder with a molecular weight of 393.95. It is freely soluble in water and in alcohol; very soluble in methanol and in chloroform; soluble in acetone; slightly soluble in ether; very slightly soluble in hexane. Oxybutynin Chloride Tablets, USP also contain magnesium stearate, microcrystalline cellulose, and pregelatinized starch. Oxybutynin Chloride Tablets, USP are for oral administration. Therapeutic Category: Antispasmodic, anticholinergic. FDA approved dissolution test specifications differ from USP. Chem Structure

Ciprofloxacin ophthalmic solution is a synthetic, sterile, multiple dose, antimicrobial for topical ophthalmic use. Ciprofloxacin is a fluoroquinolone antibacterial active against a broad spectrum of gram-positive and gram-negative ocular pathogens. It is available as the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinoline-carboxylic acid. It is a faint to light yellow crystalline powder with a molecular weight of 385.8. Its empirical formula is C 17 H 18 FN 3 O 3 •HCl•H 2 O and its chemical structure is as follows: Ciprofloxacin differs from other quinolones in that it has a fluorine atom at the 6-position, a piperazine moiety at the 7-position, and a cyclopropyl ring at the 1-position. Each mL of Ciprofloxacin ophthalmic solution 0.3% contains : Active: ciprofloxacin HCl 3.5 mg equivalent to 3 mg base. Preservative: benzalkonium chloride 0.006%. Inactives: sodium acetate, acetic acid, mannitol 4.6%, edetate disodium 0.05%, hydrochloric acid and/or sodium hydroxide (to adjust pH) and water for injection. The pH is approximately 4.5 and the osmolality is approximately 300 mOsm. Ciprofloxacin hydrochloride

Benztropine mesylate, USP is a synthetic compound containing structural features found in atropine and diphenhydramine. It is designated chemically as 3α-(Diphenylmethoxy) -1α-H,5 α H-tropane methanesulfonate. Its molecular formula is C 21 H 25 NO•CH 4 O 3 S, and its structural formula is: Benztropine mesylate, USP is a crystalline white powder, very soluble in water, and has a molecular weight of 403.54. Each benztropine mesylate tablet, USP for oral administration contains benztropine mesylate 0.5 mg, 1 mg or 2 mg. Inactive ingredients: corn starch, dicalcium phosphate anhydrous, hydrogenated vegetable oil, lactose anhydrous, lactose monohydrate, microcrystalline cellulose, talc. Chemical structure

Brimonidine tartrate/timolol maleate ophthalmic solution 0.2%/0.5%, sterile, is a relatively selective alpha-2 adrenergic receptor agonist with a non-selective beta-adrenergic receptor inhibitor (topical intraocular pressure lowering agent). The structural formulae are: Brimonidine tartrate: 5-bromo-6-(2-imidazolidinylideneamino) quinoxaline L-tartrate; MW= 442.24 Timolol maleate: (-)-1-( tert -butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)-oxy]-2-propanol maleate (1:1) (salt); MW= 432.50 as the maleate salt In solution, Brimonidine tartrate/timolol maleate ophthalmic solution 0.2%/0.5% has a clear, greenish-yellow color. It has an osmolality of 260-330 mOsmol/kg and a pH during its shelf life of 6.5-7.3. Brimonidine tartrate appears as a pale yellow colored powder to wheatish colored powder and is soluble in water and practically insoluble in anhydrous ethanol and in toluene. Timolol maleate appears as a white or almost white, crystalline powder and is soluble in water; sparingly soluble in ethanol; slightly soluble in chloroform; practically insoluble in ether. Each mL of brimonidine tartrate/timolol maleate ophthalmic solution contains the active ingredients brimonidine tartrate 0.2% and timolol 0.5% with the inactive ingredients benzalkonium chloride 0.005%; sodium phosphate, monobasic; sodium phosphate, dibasic; water for injection; and hydrochloric acid and/or sodium hydroxide to adjust pH. brimonidine-timolol-brimo-structure brimonidine-timolol-timo-structure

Carbinoxamine maleate is a histamine-H 1 receptor blocking agent. Each immediate release tablet contains 6 mg carbinoxamine maleate for oral administration and the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. Carbinoxamine maleate is very soluble in water, freely soluble in alcohol and in chloroform. Its structure is: FDA approved dissolution test specifications differ from USP. chemicalstructure

Clomipramine Hydrochloride Capsules, USP is an antiobsessional drug that belongs to the class (dibenzazepine) of pharmacologic agents known as tricyclic antidepressants. Clomipramine Hydrochloride Capsules, USP is available as capsules of 25, 50, and 75 mg for oral administration. Clomipramine hydrochloride USP is 3-chloro-5-[3-(dimethylamino) propyl]-10,11-dihydro­ 5 H -dibenz [ b,f ] azepine monohydrochloride, and its structural formula is: Clomipramine hydrochloride, USP is a white to slightly yellow crystalline powder. It is freely soluble in water and methylene chloride; soluble in alcohol. Inactive Ingredients . D&C Yellow No. 10, FD&C Blue No. 1, (25 mg only), FD&C Red No. 40, (25 mg and 75 mg only), gelatin, magnesium stearate, pregelatinized starch, titanium dioxide. Chemical structure

Diclofenac Potassium Capsule is a nonsteroidal anti-inflammatory drug, available as liquid-filled capsules of 25 mg for oral administration. Diclofenac potassium is a white to slight yellowish crystalline powder. It is sparingly soluble in water at 25ºC. The chemical name is benzeneacetic acid, 2-[(2,6-dichlorophenyl) amino]-, monopotassium salt. The molecular weight is 334.24. Its molecular formula is C 14 H 10 Cl 2 NKO 2 , and it has the following chemical structure. The inactive ingredients in Diclofenac Potassiuminclude: ProSorb ® (a proprietary combination of polyethylene glycol 400, glycerin, sorbitol, povidone, polysorbate 80, and hydrochloric acid), isopropyl alcohol, and mineral oil. The capsule shells contain gelatin, sorbitol, isopropyl alcohol, glycerin, and mineral oil. chemstructure

Diclofenac Potassium powder for oral solution is a nonsteroidal anti-inflammatory drug, available as a buffered soluble powder, designed to be mixed with water prior to oral administration. Diclofenac Potassium is a white to off-white, buffered, flavored powder for oral solution packaged in individual unit dose packets. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid monopotassium salt. The molecular weight is 334.25. Its molecular formula is C 14 H 10 Cl 2 NKO 2 , and it has the following structure. The inactive ingredients in Diclofenac Potassium include: flavoring agents (anise and mint), glycerol behenate, mannitol, potassium bicarbonate, and sucralose. Chemical Structure

Difluprednate ophthalmic emulsion 0.05% is a sterile, topical anti-inflammatory corticosteroid for ophthalmic use. The chemical name is 6α, 9difluoro-11 β ,17,21-trihydroxypregna-1,4-diene-3,20-dione 21-acetate 17-butyrate (CAS number 23674-86-4). Difluprednate is represented by the following structural formula: Difluprednate has a molecular weight of 508.56, and the molecular formula is C 27 H 34 F 2 O 7 . Each mL contains: ACTIVE: difluprednate 0.5 mg (0.05%); INACTIVE: boric acid, castor oil, glycerin, polysorbate 80, water for injection, sodium acetate, edetate disodium, sodium hydroxide (to adjust the pH to 5.2 to 5.8). The emulsion is essentially isotonic with a tonicity of 304 to 411 mOsm/kg. PRESERVATIVE: sorbic acid 0.1%. chemicalstructure

Each diphenoxylate hydrochloride and atropine sulfate tablet, USP contains: 2.5 mg of diphenoxylate hydrochloride, USP (equivalent to 2.3 mg of diphenoxylate) and 0.025 mg of atropine sulfate, USP (equivalent to 0.01 mg of atropine) Diphenoxylate hydrochloride, an antidiarrheal, is ethyl 1-(3-cyano-3,3-diphenylpropyl)-4-phenylisonipecotate monohydrochloride and has the following structural formula: Atropine sulfate, an anticholinergic, is endo-(±)-alpha-(hydroxymethyl) benzeneacetic acid 8-methyl-8- azabicylo[3.2.1] oct-3-yl ester sulfate (2:1)] (salt) monohydrate and has the following structural formula: A subtherapeutic amount of atropine sulfate is present to discourage deliberate overdosage. Inactive ingredients of diphenoxylate hydrochloride and atropine sulfate tablets include colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, pregelatinized starch and stearic acid. ChemicalStructureDiphen ChemicalStructureAtropine

Dorzolamide hydrochloride and timolol maleate ophthalmic solution, USP is the combination of a topical carbonic anhydrase inhibitor and a topical beta-adrenergic receptor blocking agent. Dorzolamide hydrochloride is described chemically as: ( 4S-trans )-4- (ethylamino)- 5,6-dihydro-6-methyl- 4H -thieno[2,3- b ]thiopyran-2-sulfonamide 7,7-dioxide monohydrochloride. Dorzolamide hydrochloride is optically active. The specific rotation is: Image Image Its empirical formula is C 10 H 16 N 2 O 4 S 3 •HCl and its structural formula is: Image Image Dorzolamide hydrochloride has a molecular weight of 360.91. It is a white to off-white, crystalline powder, which is soluble in water and slightly soluble in methanol and ethanol. Timolol maleate is described chemically as: (-)-1-(tert-butylamino)-3-[(4- morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate possesses an asymmetric carbon atom in its structure and is provided as the levo-isomer. The optical rotation of timolol maleate is: Image Image Its molecular formula is C 13 H 24 N 4 O 3 S•C 4 H 4 O 4 and its structural formula is: Image Image Timolol maleate has a molecular weight of 432.50. It is a white, odorless, crystalline powder which is soluble in water, methanol, and alcohol. Timolol maleate is stable at room temperature. Dorzolamide hydrochloride and timolol maleate ophthalmic solution, USP is supplied as a sterile, clear, colorless to nearly colorless, isotonic, buffered, slightly viscous, aqueous solution. The pH of the solution is approximately 5.65, and the osmolarity is 242-323 mOsM. Each mL of Dorzolamide hydrochloride and timolol maleate ophthalmic solution, USP contains 20 mg dorzolamide (22.26 mg of dorzolamide hydrochloride) and 5 mg timolol (6.83 mg timolol maleate). Inactive ingredients are sodium citrate, hydroxyethyl cellulose, sodium hydroxide, mannitol, and water for injection. Benzalkonium chloride 0.0075% is added as a preservative. a c b f

Dorzolamide Hydrochloride Ophthalmic Solution is a carbonic anhydrase inhibitor formulated for topical ophthalmic use. Dorzolamide hydrochloride is described chemically as: (4S- trans )-4-(ethylamino)-5,6-dihydro-6- methyl-4 H -thieno[2,3- b ]thiopyran-2-sulfonamide 7,7-dioxide monohydrochloride. Dorzolamide hydrochloride is optically active. The specific rotation is [α] 25°C (C=1, water) = ~ -17°. 405 nm Its empirical formula is C 10 H 16 N 2 O 4 S 3 ·HCl and its structural formula is: Dorzolamide hydrochloride has a molecular weight of 360.9 and a melting point of about 264°C. It is a white to off-white, crystalline powder, which is soluble in water and slightly soluble in methanol and ethanol. Dorzolamide Hydrochloride Ophthalmic Solution is supplied as a sterile, isotonic, buffered, slightly viscous, aqueous solution of dorzolamide hydrochloride. The pH of the solution is approximately 5.6, and the osmolarity is 260-330 mOsM. Each mL of Dorzolamide Hydrochloride Ophthalmic Solution 2% contains 20 mg dorzolamide (22.3 mg of dorzolamide hydrochloride). Inactive ingredients are hydroxyethyl cellulose, mannitol, sodium citrate dihydrate, sodium hydroxide (to adjust pH) and water for injection. Benzalkonium chloride 0.0075% is added as a preservative. chemstructure

Doxepin Hydrochloride, USP is one of a class of psychotherapeutic agents known as dibenzoxepin tricyclic compounds. The molecular formula of the compound is C19H21NO∙HCl having a molecular weight of 315.8. It is a white or almost white crystalline powder freely soluble in Water, Ethyl Alcohol (96%) and Dichlormethane. it may be represented by the following structural formula: Chemically, doxepin hydrochloride, USP is a dibenzoxepin derivative and is the first of a family of tricyclic psychotherapeutic agents. Specifically, it is an isomeric mixture of: 1-Propanamine, 3-dibenz[b,e]oxepin-11 (6H)ylidene-N,N-dimethyl-hydrochloride. Each 10 mg, 25 mg, 50 mg, 75 mg and 100 mg doxepin capsule for oral administration contains doxepin hydrochloride, USP equivalent to 10 mg, 25 mg, 50 mg, 75 mg and 100 mg of doxepin, respectively and the following inactive ingredients: Corn Starch, Dehydrate Alcohol, Dibasic Calcium Phosphate Dihydrate, Magnesium Stearate, Microcrystalline Cellulose, Silicon Dioxide, Sodium Lauryl Sulfate. The empty gelatin capsule shells contain gelatin and titanium dioxide. In addition, the 25 mg and 50 mg empty gelatin capsule shells contain FD&C Yellow No. 6 and D&C Yellow No. 10, the 75 mg and 100 mg empty gelatin capsule shells contain FD&C Green No. 3 and D&C Yellow No. 10. The imprinting ink contains Black iron oxide, Butyl Alcohol, Dehydrated Alcohol, Isopropyl Alcohol, Potassium Hydroxide, Propylene Glycol, Purified Water, Shellac and Strong Ammonia Solution. Chemical-structure

Doxepin Hydrochloride, USP is one of a class of psychotherapeutic agents known as dibenzoxepin tricyclic compounds. The molecular formula of the compound is C 19 H 21 NO•HCl having a molecular weight of 315.8. It is a white or almost white crystalline powder freely soluble in Water, Ethyl Alcohol (96%) and Dichlormethane. Chemically, Doxepin Hydrochloride USP is a dibenzoxepin derivative and is the first of a family of tricyclic psychotherapeutic agents. Specifically, it is an isomeric mixture of: 1-Propanamine, 3-dibenz[b,e]oxepin-11 (6H)ylidene-N,N-dimethylhydrochloride. Each 150 mg Doxepin capsule, USP for oral administration contains Doxepin Hydrochloride, USP equivalent to 150 mg of doxepin, the following inactive ingredients: Corn Starch, Dehydrate Alcohol, Dibasic Calcium Phosphate Dihydrate, Magnesium Stearate, Sodium Lauryl Sulfate.The empty gelatin capsule shells contain FD&C Blue No. 1, gelatin and titanium dioxide. The imprinting ink contains Black iron oxide, Butyl Alcohol, Dehydrated Alcohol, Isopropyl Alcohol, Potassium Hydroxide, Propylene Glycol, Purified Water, Shellac and Strong Ammonia Solution. Chemical-structure

Ethacrynic acid is an unsaturated ketone derivative of an aryloxyacetic acid. It is designated chemically as [2,3-dichloro-4-(2-methylene-1-oxobutyl)phenoxy] acetic acid, and has a molecular weight of 303.14. Ethacrynic acid is a white, or practically white, crystalline powder, very slightly soluble in water, but soluble in most organic solvents such as alcohols, chloroform, and benzene. Its empirical formula is C 13 H 12 Cl 2 O 4 and its structural formula is: Ethacrynate sodium, the sodium salt of ethacrynic acid, is soluble in water at 25°C to the extent of about 7 percent. Solutions of the sodium salt are relatively stable at about pH 7 at room temperature for short periods, but as the pH or temperature increases the solutions are less stable. The molecular weight of ethacrynate sodium is 325.12. Its empirical formula is C 13 H 11 Cl 2 NaO 4 and its structural formula is: Intravenous Ethacrynate Sodium is a sterile freeze-dried powder and is supplied in a vial containing: Ethacrynate sodium equivalent to ethacrynic acid - 50 mg Inactive ingredient: Mannitol - 62.5 mg chemicalstructure chemicalstructure1

Etravirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) of human immunodeficiency virus type 1 (HIV-1). The chemical name for etravirine is 4-[[6-amino-5-bromo-2-[(4-cyanophenyl)amino]-4- pyrimidinyl]oxy]-3,5-dimethylbenzonitrile. Its molecular formula is C20H15BrN6O and its molecular weight is 435.28. Etravirine has the following structural formula: Etravirine is a white to slightly yellowish-brown powder. Etravirine is practically insoluble in water over a wide pH range. It is very slightly soluble in propylene glycol and slightly soluble in ethanol. Etravirine is soluble in polyethylene glycol (PEG)400 and freely soluble in some organic solvents (e.g., N,N-dimethylformamide and tetrahydrofuran). Etravirine 100 mg tablets are available as white to off-white, oval tablets for oral administration. Each 100 mg tablet contains 100 mg of etravirine and the inactive ingredients povidone, microcrystalline cellulose, sodium lauryl sulfate, crospovidone, sodium starch glycolate, silicon dioxide and magnesium stearate. Etravirine 200 mg tablets are available as white to off-white, oval tables for oral administration. Each 200 mg tablet contains 200 mg of etravirine and the inactive ingredients povidone, microcrystalline cellulose, sodium lauryl sulfate, crospovidone, sodium starch glycolate, silicon dioxide and magnesium stearate. chemicalstructure

Fenofibrate tablets, USP are lipid regulating agents available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate, USP. The chemical name for fenofibrate, USP is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula: The empirical formula is C 20 H 21 O 4 Cl and molecular weight is 360.83; fenofibrate, USP is insoluble in water. The melting point is 79 to 82°C. Fenofibrate, USP is white or almost white, crystalline powder which is stable under ordinary conditions. Inactive Ingredients Each tablet contains colloidal silicon dioxide, crospovidone, hypromellose 2910, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate and sucrose. In addition, individual tablets contain: 48 mg tablets lecithin, polyvinyl alcohol, talc, titanium dioxide, xanthan gum, D&C yellow #10 aluminum lake, FD & C blue #2/indigo carmine aluminum lake and FD & C yellow #6/sunset yellow FCF aluminium lake. 145 mg tablets lecithin, polyvinyl alcohol, talc, titanium dioxide and xanthan gum. Image

Fenofibrate tablet, USP are a lipid regulating agent available as tablets for oral administration. Each tablet contains 54 mg or 160 mg of fenofibrate, USP. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula: The empirical formula is C 20 H 21 O 4 Cl and the molecular weight is 360.83; fenofibrate, USP is insoluble in water. The melting point is 79 to 82 ᵒ C. Fenofibrate, USP is a white or almost white, crystalline powder which is stable under ordinary conditions. Each 54 mg of fenofibrate tablet, USP contains the following inactive ingredients: Microcrystalline cellulose, colloidal silicon dioxide, crospovidone, lactose monohydrate, povidone, sodium lauryl sulfate, sodium stearyl fumarate, opadry AMB yellow powder. The opadry AMB yellow powder contains lecithin, polyvinyl alcohol, talc, titanium dioxide, D&C yellow #10 aluminum lake, FD & C blue #2/indigo carmine aluminum lake, FD & C yellow #6/sunset yellow FCF aluminum lake and xanthan gum. Each 160 mg of fenofibrate tablet, USP contains the following inactive ingredients: Microcrystalline cellulose, colloidal silicon dioxide, crospovidone, lactose monohydrate, povidone, sodium lauryl sulfate, sodium stearyl fumarate, opadry AMB white powder. The Opadry AMB white powder contains lecithin, polyvinyl alcohol, talc, titanium dioxide and xanthan gum. Fenofibrate tablets, USP meets USP Dissolution Test 3. Image

Fenofibric acid delayed-release capsules are peroxisome proliferator-activated receptor (PPAR) alpha agonist available as delayed release capsules for oral administration. Each delayed release capsule contains choline fenofibrate, equivalent to 45 mg or 135 mg of fenofibric acid. The chemical name for choline fenofibrate is ethanaminium, 2-hydroxy-N,N,N-trimethyl, 2-{4-(4­-chlorobenzoyl) phenoxy]-2-methylpropanoate (1:1) with the following structural formula: The molecular formula is C 22 H 28 ClNO 5 and the molecular weight is 421.9. Choline fenofibrate is very soluble in water and freely soluble in methanol. The melting point is approximately 210°C. Choline fenofibrate is a white to off-white crystalline powder. Each delayed release capsule contains enteric coated mini-tablets comprised of choline fenofibrate and the following inactive ingredients: Colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose 2208, methacrylic acid and ethyl acrylate copolymer dispersion (sodium lauryl sulfate, polysorbate 80 and methacrylic acid and ethyl acrylate copolymer), povidone, sodium stearyl fumarate, talc and triethyl citrate. Capsule shell contains: gelatin, iron oxide black, iron oxide yellow, sodium lauryl sulfate and titanium dioxide. Additionally, 45 mg contains: iron oxide red. 135 mg contains: FD & C blue 1, FD & C red 3, FD & C red 40. The imprinting ink contains: black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. Image

Folic acid, N-p-[[(2-amino-4-hydroxy-6-pteridinyl) methyl]amino] benzoyl]- L-glutamic acid, is a B complex vitamin containing a pteridine moiety linked by a methylene bridge to para- aminobenzoic acid, which is joined by a peptide linkage to glutamic acid. Conjugates of folic acid are present in a wide variety of foods, particularly liver, kidneys, yeast and leafy green vegetables. Commercially available folic acid is prepared synthetically. Folic acid occurs as a yellow or yellowish-orange crystalline powder and is very slightly soluble in water and insoluble in alcohol. Folic acid is readily soluble in dilute solutions of alkali hydroxides and carbonates, and solutions of the drug may be prepared with the aid of sodium hydroxide or sodium carbonate, thereby forming the soluble sodium salt of folic acid (sodium folate). Aqueous solutions of folic acid are heat sensitive and rapidly decompose in the presence of light and/or riboflavin; solutions should be stored in a cool place protected from light. The structural formula of folic acid is as follows: Each tablet, for oral administration, contains 1 mg folic acid. Folic acid tablets, USP 1 mg contain the following inactive ingredients: corn starch, microcrystalline cellulose, sodium starch glycolate and stearic acid. Chemical structure

Gatifloxacin ophthalmic solution 0.5% is a quinolone antimicrobial topical ophthalmic solution for the treatment of bacterial conjunctivitis. Its chemical name is 1-Cyclopropyl-6-fluoro-1,4-dihydro-8methoxy-7-(3-methyl-1-piperazinyl)-4-oxo-3-quinolinecarboxylic acid, anhydrous. Its molecular formula is C 19 H 23 FN 3 O 4 and its molecular weight is 375.4. Its chemical structure is: Gatifloxacin ophthalmic solution 0.5 % is a clear, pale yellow, sterile, preserved aqueous solution with an osmolality of 260-330 mOsm/kg and a pH of 5.1-5.7. Gatifloxacin ophthalmic solution 0.5% contains the active ingredient gatifloxacin 0.5% (5 mg/mL) and the inactive ingredients benzalkonium chloride 0.005%, edetate disodium, sodium chloride and water for injection. Gatifloxacin ophthalmic solution 0.5 % may contain hydrochloric acid and/or sodium hydroxide to adjust pH. chemstricture

Glycopyrrolate tablets, USP contain synthetic anticholinergic glycopyrrolate. Glycopyrrolate is a quaternary ammonium compound with the following chemical name: 3-[(cyclopentyl hydroxyphenylacetyl)oxy]-1,1-dimethylpyrrolidinium bromide. The molecular formula for glycopyrrolate is C 19 H 28 BrNO 3 , the molecular weight is 398.3 g/mol, and the structural formula is: Each 1 mg tablet contains Glycopyrrolate USP 1 mg, as the active ingredient. Each 2 mg tablet contains glycopyrrolate USP 2 mg, as the active ingredient. The inactive ingredients aredibasic calcium phosphate, lactose, magnesium stearate, povidone and sodium starch glycolate. image description

Hydroxyurea Capsules USP is an antimetabolite available for oral use as capsules containing 500 mg hydroxyurea, USP. Inactive ingredients include Colorants (D&C Yellow No. 10, FD&C Red No.3, FD&C Blue No.1), gelatin, lactose anhydrous, magnesium stearate and silicon dioxide and titanium dioxide. Hydroxyurea is a White or almost white, crystalline powder. It is hygroscopic and soluble in water, but practically insoluble in alcohol. The empirical formula is CH 4 N 2 O 2 and it has a molecular weight of 76.05. Its structural formula is: image description

Imipramine hydrochloride tablets USP are supplied in tablet form for oral administration. Imipramine hydrochloride USP, the original tricyclic antidepressant, are a member of the dibenzazepine group of compounds. It is designated 5-3-(dimethylamino) propyl-10, 11-dihydro-5H dibenz [b,f]- azepine monohydrochloride. Its structural formula is: C19H24N2 • HCl MW = 316 .88 Imipramine hydrochloride USP is a white to off-white, odorless, or practically odorless crystalline powder. It is freely soluble in water and in alcohol, soluble in acetone, and insoluble in ether and in benzene. Inactive Ingredients: Colloidal silicon dioxide, D & C red # 30 and # 40, D & C yellow # 6 and # 10, dicalcium phosphate, F D & C blue # 1 and # 2, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate, sodium starch glycolate, titanium dioxide. Chemical Structure

Ketorolac tromethamine ophthalmic solution 0.5% is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs) for ophthalmic use. Its chemical name is (±)-5-Benzoyl-2, 3-dihydro-1H 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 is 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; water for injection; sodium chloride; hydrochloric acid and/or sodium hydroxide to adjust the pH. ketorolac-tromethamine-structure

Ketorolac tromethamine tablets, USP are a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine USP is (±)-5-benzoyl-2,3-dihydro-1 H -pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1), and the chemical structure is: Ketorolac tromethamine, USP is a racemic mixture of [-]S and [+]R ketorolac tromethamine USP. Ketorolac tromethamine USP may exist in three crystal forms. All forms are equally soluble in water. Ketorolac tromethamine, USP has a pKa of 3.5 and an n-octanol/water partition coefficient of 0.26. The molecular weight of ketorolac tromethamine is 376.41. Its molecular formula is C 19 H 24 N 2 O 6 . Ketorolac tromethamine tablets USP are white to off white, film-coated, round shaped tablet, debossed “LP” above “260” on one side and plain on other side. Each tablet, for oral administration contains 10 mg ketorolac tromethamine, USP the active ingredient. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, polydextrose, polyethylene glycol, hypromellose, triacetin and titanium dioxide. chemicalstructure

The chemical name of lacosamide, the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3- methoxypropionamide (IUPAC). Lacosamide is a functionalized amino acid. Its molecular formula is C 13 H 18 N 2 O 3 and its molecular weight is 250.30. The chemical structure is: Lacosamide,USP is a white to light yellow powder. It is sparingly soluble in water and slightly soluble in acetonitrile and ethanol. 11.3 Lacosamide Oral Solution,USP Lacosamide oral solution, USP contains 10 mg of lacosamide per mL. The inactive ingredients are sorbitol solution 70% non-crystallizing, glycerin, polyethylene glycol 4000, carboxymethylcellulose sodium 7 MF, acesulfame potassium, methylparaben, purified water , anhydrous citric acid, sodium chloride, strawberry flavor 502301 T (propylene glycol, artificial flavors, acetic acid), masking flavor 501521 T (aspartame, water, propylene glycol, acetic acid, artificial flavors, ammoniated glycyrrhizin, acesulfame) Lacosamide Fig 01

Leucovorin Calcium Tablets contain either 5 mg, 10 mg, 15 mg or 25 mg leucovorin as the calcium salt of N -[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl]amino]benzoyl]- L - glutamic acid and the inactive ingredients Colloidal Silicon Dioxide, Croscarmellose Sodium, Magnesium Stearate, Microcrystalline Cellulose and Pregelatinized Starch. This is equivalent to 5.4 mg, 10.8 mg, 16.21 mg or 27.01 mg of anhydrous leucovorin calcium. Leucovorin is a water soluble form of reduced folate in the folate group; it is useful as an antidote to drugs which act as folic acid antagonists. These tablets are intended for oral administration only. The structural formula of leucovorin calcium is: Chemical structure

Lorazepam, an antianxiety agent, has the chemical formula, 7-chloro-5-( o -chlorophenyl)-1,3-dihydro-3-hydroxy-2 H -1,4-benzodiazepin-2-one: It is a nearly white powder almost insoluble in water. Each Lorazepam tablet, to be taken orally, contains 0.5 mg, 1 mg, or 2 mg of lorazepam. The inactive ingredients present are lactose anhydrous, magnesium stearate, microcrystalline cellulose, and polacrilin potassium. Lorazepam structure

Nifedipine capsules, USP (nifedipine) is an antianginal drug belonging to a class of pharmacological agents, the calcium channel blockers. Nifedipine is 3,5 pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-, dimethyl ester, C 17 H 18 N 2 O 6 , and has the structural formula: Nifedipine is a yellow crystalline substance, practically insoluble in water but soluble in ethanol. It has a molecular weight of 346.3. Nifedipine capsules, USP are formulated as soft gelatin capsules for oral administration each containing 10 mg nifedipine. Inert ingredients in the formulations are: glycerin, peppermint oil, polyethylene glycol, saccharin sodium, gelatin, FD&C Yellow #6, titanium dioxide, ink white opacode (WB) NSP‑78-18022 (comprises of: polyethylene glycol/macrogol, polyvinyl acetate phthalate, titanium dioxide, propylene glycol) and water. Chem Structure

Nifedipine capsules, USP (nifedipine) is an antianginal drug belonging to a class of pharmacological agents, the calcium channel blockers. Nifedipine is 3,5-pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-, dimethyl ester, C 17 H 18 N 2 O 6 , and has the structural formula: Nifedipine is a yellow crystalline substance, practically insoluble in water but soluble in ethanol. It has a molecular weight of 346.3. Nifedipine capsules, USP are formulated as soft gelatin capsules for oral administration each containing 20 mg nifedipine. Inert ingredients in the formulations are: glycerin, peppermint oil, polyethylene glycol, saccharin sodium, gelatin, FD&C Yellow #6, FD&C Red #40, titanium dioxide, ink white opacode (WB) NSP- 78-18022 (comprises of: polyethylene glycol/macrogol, polyvinyl acetate phthalate, titanium dioxide, propylene glycol) and water. Chem Structure

Nystatin is a polyene antifungal antibiotic obtained from Streptomyces noursei . The molecular formula for Nystatin is C47H75NO17. The molecular weight of Nystatin is 926.1. Structural formula: Nystatin topical powder is for dermatologic use. Nystatin topical powder contains 100,000 nystatin units per gram dispersed in talc. Chemical-structure

Nystatin is obtained from Streptomyces noursei. It is known to be a mixture, but the composition has not been completely elucidated. Nystatin A is closely related to amphotericin B. Each is a macro-cyclic lactone containing a ketal ring, an all-trans polyene system, and a mycosamine (3-amino-3-deoxyrhamose) moiety. Structural formula: Nystatin Oral Suspension, for oral administration, contains 100,000 USP Nystatin Units per mL. Inactive ingredients: alcohol (≤ 1% v/v), sucrose 50% w/v, peppermint oil, NF, cinnamaldehyde, disodium hydrogen phosphate, USP, carboxymethylcellulose sodium, USP, glycerin, USP, saccharin sodium, USP, cherry flavor, methylparaben, NF, propylparaben, NF and purified water, USP. May also contain sodium hydroxide, NF and/ or hydrochloric acid, NF for pH adjustment. chemstructure

Nystatin is a polyene antifungal antibiotic drug obtained from Streptomyces nursei. Structural formula: Molecular Weight 926.13 Molecular Formula C 47 H 75 NO 17 Nystatin Ointment is for dermatologic use. Nystatin Ointment for topical use contains 100,000 USP nystatin units per gram in a polyethylene and mineral oil base. Chemical-structure

Ofloxacin Ophthalmic Solution USP 0.3% is a sterile ophthalmic solution. It is a fluorinated carboxyquinolone anti-infective for topical ophthalmic use. Chemical Name: (±)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo- 7H -pyrido[1,2,3- de ]-1,4-benzoxazine-6-carboxylic acid. Contains: Active: ofloxacin 0.3% (3 mg/mL). Preservative: benzalkonium chloride (0.005%). Inactives: sodium chloride and water for injection. May also contain hydrochloric acid and/or sodium hydroxide to adjust pH. Ofloxacin Ophthalmic Solution USP, 0.3% is unbuffered and formulated with a pH of 6.4 (range - 6.0 to 6.8). It has an osmolality of 300 mOsm/kg. Ofloxacin is a fluorinated 4-quinolone which differs from other fluorinated 4-quinolones in that there is a six member (pyridobenzoxazine) ring from positions 1 to 8 of the basic ring structure. chemstruc

Ofloxacin Otic Solution 0.3% is a sterile aqueous anti-infective (antibacterial) solution for otic use. Chemically, ofloxacin has three condensed 6-membered rings made up of a fluorinated carboxyquinolone with a benzoxazine ring. The chemical name of ofloxacin is: (±)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7 H -pyrido [1,2,3- de ]-1,4-benzoxazine-6-carboxylic acid. The empirical formula of ofloxacin is C18H20FN3O4 and its molecular weight is 361.38. The structural formula is Ofloxacin otic solution contains 0.3% (3 mg/mL) ofloxacin with benzalkonium chloride (0.0025%), sodium chloride (0.9%), and water for injection. Hydrochloric acid and/or sodium hydroxide may be added to adjust the pH 6.5±0.5. chemstruc

Oseltamivir phosphate, USP, an influenza neuraminidase inhibitor (NAI), is available as: A powder for oral suspension, which when constituted with water as directed contains 6 mg per mL oseltamivir base. In addition to the active ingredient, the powder for oral suspension contains monosodium citrate, saccharin sodium, sodium benzoate, sorbitol, titanium dioxide, tutti-frutti flavoring, and xanthan gum. Oseltamivir phosphate, USP is a white to off white powder with the chemical name (3R,4R,5S)-4-acetylamino-5- amino-3-(1-ethylpropoxy)-1-cyclohexene-1-carboxylic acid, ethyl ester, phosphate (1:1). The chemical formula is C16H28N2O4 (free base). The molecular weight is 312.4 for oseltamivir free base and 410.4 for oseltamivir phosphate salt. The structural formula is as follows: chemicalstructure

Oxazepam, USP is the first of a chemical series of compounds known as the 3-hydroxybenzodiazepinones. A therapeutic agent providing versatility and flexibility in control of common emotional disturbances, this product exerts prompt action in a wide variety of disorders associated with anxiety, tension, agitation, and irritability, and anxiety associated with depression. In tolerance and toxicity studies on several animal species, this product reveals significantly greater safety factors than related compounds (chlordiazepoxide and diazepam) and manifests a wide separation of effective doses and doses inducing side effects. Oxazepam capsule, USP contains 10 mg, 15 mg, or 30 mg oxazepam, USP. The following inactive ingredients are contained in these capsules: lactose monohydrate, pregelatinized starch, croscarmellose sodium, hypromellose, sodium lauryl sulfate, and magnesium stearate. The capsule shell contains gelatin and titanium dioxide. The 10 mg capsule also contains: D&C Red #28 and FD&C Red #40, the 15 mg capsule also contains: FD&C Red #40 and D&C Yellow #10 and the 30 mg capsule also contains: D&C Red #28, FD&C Red #40 and FD&C Blue #1. The imprinting ink contains strong ammonia solution, black iron oxide, potassium hydroxide, propylene glycol, purified water, titanium dioxide, FD&C Blue #2 aluminum lake and shellac. Oxazepam, USP is 7-chloro-1,3-dihydro-3-hydroxy-5-phenyl-2H-1,4-benzodiazepin-2-one. A white crystalline powder with a molecular weight of 286.7, its structural formula is as follows: chemstucture.jpg

Phenylephrine Hydrochloride Ophthalmic Solution, USP is a sterile, clear, colorless, topical α- adrenergic agonist for ophthalmic use. The active ingredient is represented by the chemical structure Chemical Name: (R)-3-hydroxy-α[(methylamino)methyl]benzenemethanol hydrochloride. Molecular Formula: C 9 H 13 NO 2 .HCl Molecular Weight: 203.67 g/mol Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% contains: ACTIVE: Phenylephrine Hydrochloride 25 mg (2.5%); INACTIVES: Sodium Phosphate Dibasic, Sodium Phosphate Monobasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 340 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%). Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% contains: ACTIVE: Phenylephrine Hydrochloride 100 mg (10%); INACTIVES: Sodium Phosphate Dibasic, Sodium Phosphate Monobasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 985 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%). chemicalstructure

Prochlorperazine, USP is a phenothiazine derivative, present in prochlorperazine tablets as the maleate. Its chemical name is 2-chloro-10- [3-(4- methyl-1-piperazinyl) propyl]-10 H -phenothiazine ( Z )-2-butenedioate (1:2) and has the following structure: Prochlorperazine maleate is classified as an anti-emetic and antipsychotic agent. Prochlorperazine maleate, USP is a white to pale yellow crystalline powder. It is slightly soluble in warm chloroform, practically insoluble in water and in alcohol. Each film-coated tablet, for oral administration contains prochlorperazine maleate USP, 8.104 mg or 16.208 mg equivalent to prochlorperazine USP, 5 mg or 10 mg respectively. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, purified water and titanium dioxide. FDA approved dissolution test specifications differ from USP. chemstruct

Each gram of Procto-Med HC TM 2.5% (Hydrocortisone Cream USP, 2.5%) contains 25 mg of hydrocortisone in a cream base of cetyl alcohol, methylparaben, propylene glycol, propylparaben, purified water, sodium lauryl sulfate, and stearyl alcohol. Chemically, hydrocortisone is [Pregn-4-ene-3,20-dione,11,17,21-trihydroxy-,(11β)-] with the molecular formula (C 21 H 30 O 5 ) and is represented by the following structural formula: Its molecular weight is 362.47 and its CAS Registry Number is 50-23-7. The topical corticosteroids, including hydrocortisone, constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. chemstructure

Uses Helps relive the pain, itching, and burning associated with hemorrhoids and other anorectal disorders.

Theophylline is structurally classified as a methylxanthine. It occurs as a white, practically odorless, crystalline powder with a bitter taste. Anhydrous theophylline has the chemical name 1,3-Dimethyl-3,7-dihydro-1H-purine-2,6-dione, and is represented by the following structural formula: This product allows a 12-hour dosing interval for a majority of patients and a 24-hour dosing interval for selected patients (see DOSAGE AND ADMINISTRATION section for description of appropriate patient populations). Each theophylline extended-release tablet for oral administration contains either 300 mg or 450 mg of anhydrous theophylline. Theophylline extended-release tablets also contain as inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate and povidone. chemicalsrtucture

Timolol maleate, USP is a non-selective beta-adrenergic receptor blocking agent. Its chemical name is (-)-1-( tert -butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2­ propanol maleate (1:1) (salt). Timolol maleate possesses an asymmetric carbon atom in its structure and is provided as the levo-isomer. The optical rotation of timolol maleate is: 25° [α] in 1.0N HCl (C = 5%) = -12.2° (-11.7° to -12.5°) 405 nm Its molecular formula is C 13 H 24 N 4 O 3 S•C 4 H 4 O 4 and its structural formula is: Timolol maleate has a molecular weight of 432.50. It is a white or almost white, crystalline powder which is soluble in water; sparingly soluble in ethanol; slightly soluble in chloroform; practically insoluble in ether. Timolol maleate ophthalmic solution, USP is stable at room temperature. Timolol maleate ophthalmic solution, USP is supplied as a sterile, isotonic, buffered, aqueous solution of timolol maleate in one dosage strength. Each mL of timolol maleate ophthalmic solution 0.5% contains 5 mg of timolol (6.8 mg of timolol maleate). Inactive ingredients: monobasic and dibasic sodium phosphate, sodium hydroxide to adjust pH (6.5 to 7.5), and water for injection. Benzalkonium chloride 0.01% is added as preservative. chemicalstructure

Varenicline tablets contain varenicline (as the tartrate salt), which is a partial nicotinic agonist selective for α 4 β 2 nicotinic acetylcholine receptor subtypes. Varenicline, as the tartrate salt, is a powder which is a white to off-white to slightly yellow solid with the following chemical name: 7,8,9,10-tetrahydro-6,10-methano- 6 H -pyrazino[2,3- h][3]benzazepine, (2 R ,3 R )-2,3-dihydroxybutanedioate (1:1). It is highly soluble in water. Varenicline tartrate has a molecular weight of 361.35 Daltons, and a molecular formula of C 13 H 13 N 3 • C 4 H 6 O 6 . The chemical structure is: Varenicline tablets is supplied for oral administration in two strengths: a 0.5 mg, white to off-white, capsule shaped, biconvex, film coated tablet, debossed with 'Ml' on one side and plain on other side and a 1 mg, light blue to blue, capsule shaped, biconvex, film coated tablet, debossed with 'M2' on one side and plain on other side. Each 0.5 mg Varenicline tablet contains 0.85 mg of varenicline tartrate equivalent to 0.5 mg of varenicline free base; each 1 mg Varenicline tablet contains 1.71 mg of varenicline tartrate equivalent to 1 mg of varenicline free base. The following inactive ingredients are included in the tablets: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, maltodextrin, methyl alcohol, colloidal silicon dioxide, magnesium stearate, purified water, lnstacoat Universal White (for 0.5 mg), lnstacoat Universal blue (for 1 mg). Varenicline-01