sandoz inc - Medication Listings

Browse 202 medications manufactured by sandoz inc. Open a product record to review dosage forms, strengths, packaging, and related navigation.

Brimonidine Tartrate BRIMONIDINE TARTRATE
2 mg/ml Liquid
SANDOZ INC FDA Rx Only

Brimonidine tartrate ophthalmic solution, 0.2% is a relatively selective alpha-2 adrenergic agonist for ophthalmic use. The chemical name of brimonidine tartrate is 5-bromo-6-(2-imidazolidinylideneamino) quinoxaline L-tartrate. It has a molecular weight of 442.24 as the tartrate salt and is water soluble (34 mg/mL) at pH 6.5. The structural formula is: In solution, brimonidine tartrate ophthalmic solution, 0.2% has a clear, greenish-yellow color. It has an osmolality of 280-330 mOsml/kg and a pH of 5.6-6.6. Each mL of brimonidine tartrate ophthalmic solution, 0.2% contains: Active: brimonidine tartrate 0.2% (2 mg/mL). Preservative: benzalkonium chloride 0.005% (0.05 mg). Inactives: citric acid; polyvinyl alcohol; purified water; sodium chloride and sodium citrate. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH. chemical

Brimonidine Tartrate and Timolol Maleate BRIMONIDINE TARTRATE AND TIMOLOL MALEATE
SANDOZ INC FDA Rx Only

Brimonidine tartrate and 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 and timolol maleate ophthalmic solution, 0.2%/0.5% has a clear, greenish-yellow color. It has an osmolality of 260 to 330 mOsmol/kg and a pH during its shelf life of 6.5 to 7.3. Brimonidine tartrate appears as an off-white or white to pale-yellow powder and is soluble in both water (1.5 mg/mL) and in the product vehicle (3 mg/mL) at pH 7.2. Timolol maleate appears as a white, odorless, crystalline powder and is soluble in water, methanol, and alcohol. Each mL of brimonidine tartrate and timolol maleate ophthalmic solution, 0.2%/0.5% contains Actives: brimonidine tartrate 0.2% (2 mg), timolol maleate 6.8 mg equivalent to timolol 0.5% (5 mg). Preservative: benzalkonium chloride 0.005%. Inactives: purified water; sodium phosphate, monobasic; sodium phosphate, dibasic; hydrochloric acid and/or sodium hydroxide to adjust pH. brimonidinetarstructure timololmaleatestruct

Brinzolamide BRINZOLAMIDE
1 % Drops
SANDOZ INC FDA Rx Only

Brinzolamide ophthalmic suspension 1% contains a carbonic anhydrase inhibitor formulated for multidose topical ophthalmic use. Brinzolamide is described chemically as: (R)-(+)-4-Ethylamino-2-(3-methoxypropyl)-3,4-dihydro-2H-thieno [3,2-e]-1,2-thiazine-6-sulfonamide-1,1- dioxide. Its empirical formula is C 12 H 21 N 3 O 5 S 3 , and its structural formula is: Brinzolamide has a molecular weight of 383.5 g/mol and a melting point of about 131°C. It is a white powder, which is insoluble in water, very soluble in methanol and soluble in ethanol. Brinzolamide ophthalmic suspension 1% is supplied as a sterile, aqueous suspension of brinzolamide which has been formulated to be readily suspended and slow settling, following shaking. It has a pH of approximately 7.5 and an osmolality of 300 mOsm/kg. Each mL of brinzolamide ophthalmic suspension 1% contains: Active ingredient: brinzolamide 10 mg; Preservative: benzalkonium chloride 0.1 mg; Inactives: carbomer 974P, edetate disodium, mannitol, hydrochloric acid and/or sodium hydroxide to adjust pH, purified water, sodium chloride, and tyloxapol. chemical

Bromocriptine mesylate BROMOCRIPTINE MESYLATE
SANDOZ INC FDA Rx Only

Bromocriptine mesylate is an ergot derivative with potent dopamine receptor agonist activity. Bromocriptine mesylate is chemically designated as Ergotaman-3´,6´,18-trione, 2-bromo-12´-hydroxy-2´-(1-methylethyl)-5´-(2-methylpropyl)-, (5’α)-monomethanesulfonate (salt). The structural formula is: 2.5 mg Tablets Each tablet for oral administration contains bromocriptine mesylate equivalent to 2.5 mg bromocriptine. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, disodium edetate, lactose monohydrate, magnesium stearate, maleic acid, and povidone. image-01

Budesonide BUDESONIDE
2 ml Liquid
SANDOZ INC FDA Rx Only

Budesonide, the active component of budesonide inhalation suspension, is a corticosteroid designated chemically as (RS)-11β, 16α, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal with butyraldehyde. Budesonide inhalation suspension is provided as a mixture of two epimers (22R and 22S). The molecular formula of budesonide is C 25 H 34 O 6 and its molecular weight is 430.5. Its structural formula is: Budesonide is a white to off-white, tasteless, odorless powder that is practically insoluble in water and in heptane, sparingly soluble in ethanol, and freely soluble in chloroform. Its partition coefficient between octanol and water at pH 7.4 is 1.6 x 10 3 . Budesonide inhalation suspension is a sterile suspension for inhalation via jet nebulizer and contains the active ingredient budesonide (micronized), and the inactive ingredients: citric acid monohydrate, disodium edetate, polysorbate 80, sodium chloride, sodium citrate dihydrate and water for injection. Three dose strengths are available in single-dose ampules: 0.25 mg, 0.5 mg, and 1 mg per 2 mL ampule. For budesonide inhalation suspension, like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari-LC-Jet Plus Nebulizer/Pari Master compressor system, under in vitro conditions, the mean delivered dose at the mouthpiece (% nominal dose) was approximately 17% at a mean flow rate of 5.5 L/min. The mean nebulization time was 5 minutes or less. Budesonide inhalation suspension should be administered from jet nebulizers at adequate flow rates, via face masks or mouthpieces [see Dosage and Administration ( 2 )]. Structure

Bumetanide BUMETANIDE
SANDOZ INC FDA Rx Only

Bumetanide is a loop diuretic, available as scored tablets. Each tablet for oral administration contains 0.5 mg, 1 mg or 2 mg of bumetanide. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, corn starch, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn), talc, with the following dye systems: 0.5 mg- D&C yellow No. 10 aluminum lake, FD&C blue No. 1 aluminum lake and FD&C red No. 40 aluminum lake; 1 mg- D&C yellow No. 10 aluminum lake; 2 mg- synthetic black iron oxide, synthetic red iron oxide and synthetic yellow iron oxide. Chemically, bumetanide is 3-(butylamino)-4-phenoxy-5-sulfamoylbenzoic acid. It is a practically white powder having a calculated molecular weight of 364.42, and the following structural formula: Chemical-Structure.jpg

Butalbital, aspirin, and caffeine BUTALBITAL ASPIRIN AND CAFFEINE

Butalbital, aspirin, and caffeine capsules, USP are supplied in capsule form for oral administration. Each capsule contains the following active ingredients: butalbital, USP 50 mg aspirin, USP 325 mg caffeine, USP 40 mg Butalbital (5-allyl-5-isobutylbarbituric acid) is a short- to intermediate-acting barbiturate. It has the following Molecular Formula: C 11 H 16 N 2 O 3 Molecular Weight: 224.26 Structural Formula: Aspirin (benzoic acid, 2-(acetyloxy)-) is an analgesic, antipyretic, and anti-inflammatory. It has the following Molecular Formula: C 9 H 8 O 4 Molecular Weight: 180.16 Structural Formula: Caffeine (1, 3, 7-trimethylxanthine) is a central nervous system stimulant. It has the following Molecular Formula: C 8 H 10 N 4 O 2 Molecular Weight: 194.19 Structural Formula: Inactive Ingredients: pregelatinized starch, microcrystalline cellulose, sodium starch glycolate, trimyristin, talc, colloidal silicon dioxide, D&C Yellow No. 10, FD&C Green No. 3, and gelatin. The capsule imprinting ink contains: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol, methanol, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, and D&C Yellow No.10 Aluminum Lake. butalbital-chemical-structure aspirin-chemical-structure caffeine-chemical-structure

Carbidopa, Levodopa, and Entacapone CARBIDOPA LEVODOPA AND ENTACAPONE

Carbidopa, levodopa and entacapone tablets are a combination of carbidopa, levodopa, and entacapone for the treatment of Parkinson's disease. Carbidopa, an inhibitor of aromatic amino acid decarboxylation, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 244.3. It is designated chemically as (-)-L-(α-hydrazino-(α-methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its empirical formula is C 10 H 14 N 2 O 4 •H 2 O, and its structural formula is: Tablet content is expressed in terms of anhydrous carbidopa, which has a molecular weight of 226.3. Levodopa, an aromatic amino acid, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 197.2. It is designated chemically as (-)-L-α-amino-β-(3,4-dihydroxybenzene) propanoic acid. Its empirical formula is C 9 H 11 NO 4 , and its structural formula is: Entacapone, a COMT inhibitor, is a nitro-catechol-structured compound with a molecular weight of 305.3. The chemical name of entacapone is (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethyl-2-propenamide. Its empirical formula is C 14 H 15 N 3 O 5 and its structural formula is: Carbidopa, Levodopa and Entacapone Tablets are supplied as tablets in 6 strengths: Carbidopa, Levodopa and Entacapone Tablets: 12.5 mg of carbidopa, 50 mg of levodopa and 200 mg of entacapone Carbidopa, Levodopa and Entacapone Tablets: 18.75 mg of carbidopa, 75 mg of levodopa and 200 mg of entacapone Carbidopa, Levodopa and Entacapone Tablets: 25 mg of carbidopa, 100 mg of levodopa and 200 mg of entacapone Carbidopa, Levodopa and Entacapone Tablets: 31.25 mg of carbidopa, 125 mg of levodopa and 200 mg of entacapone Carbidopa, Levodopa and Entacapone Tablets: 37.5 mg of carbidopa, 150 mg of levodopa and 200 mg of entacapone Carbidopa, Levodopa and Entacapone Tablets: 50 mg of carbidopa, 200 mg of levodopa and 200 mg of entacapone Inactive Ingredients: corn starch, croscarmellose sodium, glycerol 85%, hypromellose, magnesium stearate, mannitol, polysorbate 80, povidone, sucrose, red iron oxide, and titanium dioxide. Tablets containing 12.5 mg of carbidopa, 50 mg of levodopa and 200 mg of entacapone, tablets containing 25 mg of carbidopa, 100 mg of levodopa and 200 mg of entacapone, and tablets containing 37.5 mg of carbidopa, 150 mg of levodopa and 200 mg of entacapone also contain yellow iron oxide. carbidopa_chemstructure levodopa_chemstructure entacapone_chemstructure

CARMUSTINE CARMUSTINE
100 mg Injection
SANDOZ INC. FDA Rx Only

The active ingredient in carmustine for injection, USP is a nitrosourea with the chemical name 1,3-bis(2-chloroethyl)-1-nitrosourea and a molecular weight of 214.05. The drug product is supplied as sterile lyophilized pale yellow granules or a congealed mass, and it is highly soluble in alcohol and lipids, and poorly soluble in water. Carmustine for injection, USP is administered by intravenous infusion after reconstitution, as recommended. The structural formula of carmustine is: Carmustine for injection, USP is available in 100-mg single-dose vials of lyophilized material. Sterile diluent for constitution of carmustine for injection, USP is co-packaged with the active drug product for use in constitution of the lyophile. The diluent is supplied in a vial containing 3 mL of Dehydrated Alcohol Injection, USP. structure

Carteolol Hydrochloride CARTEOLOL HYDROCHLORIDE
SANDOZ INC FDA Rx Only

Carteolol Hydrochloride Ophthalmic Solution USP, 1% is a nonselective beta-adrenoceptor blocking agent for ophthalmic use. The chemical name for carteolol hydrochloride is (±)-5-[3-[(1,1-dimethylethyl) amino]-2-hydroxypropoxy]-3,4-dihydro-2(1H)-quinolinone monohydrochloride. The structural formula is as follows: C 16 H 24 N 2 O 3 •HCI Mol. Wt. 328.84 Each mL of sterile solution contains Active: carteolol hydrochloride 10 mg (1%). Preservative: benzalkonium chloride 0.05 mg (0.005%). Inactives: sodium chloride, monobasic and dibasic sodium phosphate, sodium hydroxide and/or hydrochloric acid (to adjust pH to 6.0 - 8.0) and purified water. chemical

CASPOFUNGIN ACETATE CASPOFUNGIN ACETATE
50 mg Injection
SANDOZ INC FDA Rx Only

Caspofungin acetate for injection is a sterile, lyophilized product for intravenous (IV) infusion that contains a semisynthetic lipopeptide (echinocandin) compound synthesized from a fermentation product of Glarea lozoyensis. Caspofungin acetate is an echinocandin antifungal that inhibits the synthesis of β (1,3)-D-glucan, an integral component of the fungal cell wall. Caspofungin acetate is 1-[(4R,5S)-5-[(2-aminoethyl)amino]-N2-(10,12-dimethyl-1-oxotetradecyl)-4-hydroxy-L-ornithine]-5-[(3 R )-3-hydroxy-L-ornithine] pneumocandin B 0 diacetate (salt). Caspofungin acetate for injection, 50 mg contains 50 mg of caspofungin equivalent to 55.5 mg of caspofungin acetate. Caspofungin acetate for injection, 50 mg also contains: 39 mg sucrose, 26 mg mannitol, 2 mg glacial acetic acid added as a buffering agent, and sodium hydroxide added as a pH adjuster ingredient. Caspofungin acetate for injection, 70 mg contains 70 mg of caspofungin equivalent to 77.7 mg of caspofungin acetate. Caspofungin acetate for injection, 70 mg also contains 54 mg sucrose, 36 mg mannitol, 2.7 mg glacial acetic acid added as a buffering agent, and sodium hydroxide added as a pH adjuster ingredient. Caspofungin acetate is a hygroscopic, white to off-white powder. It is freely soluble in water and methanol, and slightly soluble in ethanol. The pH of a saturated aqueous solution of caspofungin acetate is approximately 6.6. The empirical formula is C 52 H 88 N 10 O 15 ∙2C 2 H 4 O 2 and the formula weight is 1213.42. The structural formula is: Chemical- Structure

Cefazolin CEFAZOLIN
SANDOZ INC FDA Rx Only

Cefazolin for injection, USP is a semi-synthetic cephalosporin for parenteral administration. It is the sodium salt of (6R, 7R)-3-[[(5-methyl-1,3,4-thiadiazol-2-yl)thio]methyl]-8-oxo-7-[2-(1H-tetrazol-1-yl)acetamido]-5-thia-1-azabicyclo [4.2.0]oct-2-ene-2-carboxylic acid. Structural Formula: Molecular Formula: C 14 H 13 N 8 NaO 4 S 3 Molecular Weight: 476.5 The sodium content is 24 mg (1.05 mEq) per 500 mg of cefazolin sodium and 48 mg (2.1 mEq) per 1 gram of cefazolin sodium. Cefazolin for Injection, USP is a sterile, white to yellowish powder. Cefazolin for injection, USP is supplied in vials equivalent to 500 mg of cefazolin or to 1 gram of cefazolin. chemical-structure

Cefazolin CEFAZOLIN
SANDOZ INC FDA Rx Only

Cefazolin for injection, USP is a semi-synthetic cephalosporin for parenteral administration. It is the sodium salt of (6R, 7R)-3-[[(5-methyl-1,3,4-thiadiazol-2-yl)thio]methyl]-8-oxo-7-[2-(1H-tetrazol-1-yl)acetamido]-5-thia-1-azabicyclo [4.2.0]oct-2-ene-2-carboxylic acid. Structural Formula: Molecular Formula: C 14 H 13 N 8 NaO 4 S 3 Molecular Weight: 476.5 The sodium content is 48 mg (2.1 mEq) per 1 gram of cefazolin sodium. Cefazolin for Injection, USP is a sterile, white to yellowish powder. Each pharmacy bulk package bottle contains cefazolin sodium equivalent to 10 grams of cefazolin. A pharmacy bulk package is a container of a sterile preparation for parenteral use that contains many single doses. The contents of this pharmacy bulk package are intended for use by a pharmacy admixture service for addition to suitable parenteral fluids in the preparation of admixtures for intravenous infusion (see DOSAGE AND ADMINISTRATION, Directions for Proper Use of Pharmacy Bulk Package ). FURTHER DILUTION IS REQUIRED. NOT FOR DIRECT INFUSION. chemical-structure

Cefdinir CEFDINIR
300 mg
SANDOZ INC FDA Rx Only

Cefdinir capsules contain the active ingredient cefdinir, an extended-spectrum, semisynthetic cephalosporin, for oral administration. Chemically, cefdinir is [6R-[6α,7β (Z)]]-7-[[(2-amino-4-thiazolyl)(hydroxyimino)acetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid. Cefdinir is a white to slightly brownish-yellow solid. It is slightly soluble in dilute hydrochloric acid and sparingly soluble in 0.1 M pH 7.0 phosphate buffer. The empirical formula is C 14 H 13 N 5 O 5 S 2 and the molecular weight is 395.42. Cefdinir has the structural formula shown below: Cefdinir capsules contain 300 mg cefdinir and the following inactive ingredients: carboxymethylcellulose calcium, colloidal silicone dioxide, magnesium stearate, and polyoxyl 40 stearate. The capsule shells contain FD&C Blue #2; gelatin, titanium dioxide. The printing ink ingredients are shellac, propylene glycol, black iron oxide, ammonia hydroxide, and potassium hydroxide. cefdinir-chemical-structure

Cefpodoxime Proxetil CEFPODOXIME PROXETIL
SANDOZ INC FDA Rx Only

Cefpodoxime proxetil is an orally administered, extended spectrum, semi-synthetic antibiotic of the cephalosporin class. The chemical name is (RS)-1(isopropoxycarbonyloxy) ethyl (+)-(6R,7R)-7-[2-(2-amino-4-thiazolyl)-2-{(Z)methoxyimino} acetamido]-3-methoxymethyl-8-oxo-5-thia-1-azabicyclo [4.2.0]oct-2-ene-2-carboxylate. Its structural formula is represented below: Molecular Formula: C 21 H 27 N 5 O 9 S 2 Molecular Weight: 557.6 Cefpodoxime proxetil is a prodrug; its active metabolite is cefpodoxime. All doses of cefpodoxime proxetil in this insert are expressed in terms of the active cefpodoxime moiety. The drug is supplied as film-coated tablets. Cefpodoxime proxetil tablets, USP contain cefpodoxime proxetil equivalent to 100 mg or 200 mg of cefpodoxime activity. Each film-coated tablet contains the following inactive ingredients: carboxymethylcellulose calcium, crospovidone, FD&C Yellow No. 6, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, talc and titanium dioxide. chemical-structure

Ceftriaxone Sodium CEFTRIAXONE SODIUM
SANDOZ INC FDA Rx Only

Ceftriaxone for injection, USP is a sterile, semisynthetic, broad-spectrum cephalosporin antibiotic for intravenous or intramuscular administration. Ceftriaxone sodium is (6 R , 7 R )-7-[2-(2-Amino-4-thiazolyl) glyoxylamido]-8-oxo-3-[[(1,2,5,6-tetrahydro-2-methyl-5,6-dioxo- as -triazin-3-yl)thio]methyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7 2 -( Z )-( O -methyloxime), disodium salt, sesquaterhydrate. The chemical formula of ceftriaxone sodium is C 18 H 16 N 8 Na 2 O 7 S 3 •3.5H 2 O. It has a calculated molecular weight of 661.60 and the following structural formula: Ceftriaxone sodium is a white to yellowish crystalline powder which is readily soluble in water, sparingly soluble in methanol and very slightly soluble in ethanol. The pH of a 1% aqueous solution is approximately 6.7. The color of ceftriaxone sodium solutions ranges from light yellow to amber, depending on the length of storage, concentration and diluent used. Each Pharmacy Bulk Package is supplied as a dry powder in Pharmacy Bulk Package bottles containing sterile ceftriaxone sodium, USP equivalent to 10 grams of ceftriaxone and is intended for intravenous infusion only. Ceftriaxone sodium contains approximately 83 mg (3.6 mEq) of sodium per gram of ceftriaxone activity. A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for intravenous infusion. FURTHER DILUTION IS REQUIRED BEFORE USE. (See DOSAGE AND ADMINISTRATION , and DIRECTIONS FOR PROPER USE OF PHARMACY BULK PACKAGE .) chemical-structure

Ceftriaxone Sodium CEFTRIAXONE SODIUM
SANDOZ INC FDA Rx Only

Ceftriaxone for injection, USP is a sterile, semisynthetic, broad-spectrum cephalosporin antibiotic for intravenous or intramuscular administration. Ceftriaxone sodium is (6 R , 7 R )-7-[2-(2-Amino-4-thiazolyl) glyoxylamido]-8-oxo-3-[[(1,2,5,6-tetrahydro-2-methyl-5,6-dioxo- as -triazin-3-yl)thio]methyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7 2 -( Z )-( O -methyloxime), disodium salt, sesquaterhydrate. The chemical formula of ceftriaxone sodium is C 18 H 16 N 8 Na 2 O 7 S 3 •3.5H 2 O. It has a calculated molecular weight of 661.60 and the following structural formula: Ceftriaxone sodium is a white to yellowish crystalline powder which is readily soluble in water, sparingly soluble in methanol and very slightly soluble in ethanol. The pH of a 1% aqueous solution is approximately 6.7. The color of ceftriaxone sodium solutions ranges from light yellow to amber, depending on the length of storage, concentration and diluent used. Each vial contains ceftriaxone sodium equivalent to 250 mg, 500 mg, 1 gram or 2 grams of ceftriaxone activity. Ceftriaxone sodium contains approximately 83 mg (3.6 mEq) of sodium per gram of ceftriaxone activity. chemical-structure

Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE
SANDOZ INC FDA OTC

Uses Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • sneezing • itchy, watery eyes • itching of the nose or throat

Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE
SANDOZ INC FDA OTC

Uses Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • sneezing • itchy, watery eyes itching of the nose or throat

Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE
SANDOZ INC FDA OTC

Uses Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • sneezing • itchy, watery eyes • itching of the nose or throat

Chlorpromazine Hydrochloride CHLORPROMAZINE HYDROCHLORIDE
SANDOZ, INC. FDA Rx Only

Chlorpromazine is 10-(3-dimethylaminopropyl)-2-chlorphenothiazine, a dimethylamine derivative of phenothiazine. It is present in an oral concentrate as the hydrochloride salt. Concentrate - Each mL of clear, colorless to pale yellow solution contains chlorpromazine hydrochloride, 30 or 100 mg. Inactive ingredients consist of citric acid anhydrous, edetate disodium, sodium benzoate, sodium citrate dihydrate, sucralose, and purified water. Chemical Structure

CIMERLI RANIBIZUMAB EQRN
SANDOZ INC FDA Rx Only

Ranibizumab-eqrn is a recombinant humanized IgG1 kappa isotype monoclonal antibody fragment designed for intraocular use. Ranibizumab-eqrn binds to and inhibits the biologic activity of human vascular endothelial growth factor A (VEGF-A). Ranibizumab-eqrn, which lacks an Fc region, has a molecular weight of approximately 48 kilodaltons and is produced by an E. coli expression system. CIMERLI (ranibizumab-eqrn) injection is a sterile, colorless to pale yellow solution in a single-dose glass vial for intravitreal injection. CIMERLI is supplied as a preservative-free, sterile solution in a single-dose container designed to deliver 0.05 mL of 10 mg/mL ranibizumab-eqrn (0.5 mg dose vial) or 6 mg/mL ranibizumab-eqrn (0.3 mg dose vial) aqueous solution with 10 mM histidine HCl, 10% α,α trehalose dihydrate, 0.01% polysorbate 20, pH 5.5.

Ciprofloxacin and Dexamethasone CIPROFLOXACIN AND DEXAMETHASONE
SANDOZ INC FDA Rx Only

Ciprofloxacin 0.3% and dexamethasone 0.1% sterile otic suspension contains the quinolone antimicrobial, ciprofloxacin hydrochloride, combined with the corticosteroid, dexamethasone, in a sterile, preserved suspension for otic use. Each mL of ciprofloxacin and dexamethasone otic suspension contains Actives: ciprofloxacin hydrochloride equivalent to 3 mg ciprofloxacin base and 1 mg dexamethasone. Preservative: 0.1 mg benzalkonium chloride. Inactives: acetic acid, boric acid, edetate disodium, hydroxyethyl cellulose, purified water, sodium acetate, sodium chloride, and tyloxapol. Sodium hydroxide or hydrochloric acid may be added for adjustment of pH. Ciprofloxacin, a quinolone antimicrobial is available as the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinoline carboxylic acid. The empirical formula is C 17 H 18 FN 3 O 3 ·HCl·H 2 O. The molecular weight is 385.82 g/mol and the structural formula is: Dexamethasone, 9-fluoro-11(beta),17,21-trihydroxy-16(alpha)-methylpregna-1,4-diene-3,20-dione, is a corticosteroid. The empirical formula is C 22 H 29 FO 5 . The molecular weight is 392.46 g/mol and the structural formula is: figure1 figure2

CIPRO HC CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE
SANDOZ INC FDA Rx Only

CIPRO ® HC OTIC (ciprofloxacin hydrochloride and hydrocortisone otic suspension) contains the synthetic broad spectrum antibacterial agent, ciprofloxacin hydrochloride, combined with the anti-inflammatory corticosteroid, hydrocortisone, in a preserved, nonsterile suspension for otic use. Each mL of CIPRO ® HC OTIC contains ciprofloxacin hydrochloride (equivalent to 2 mg ciprofloxacin), 10 mg hydrocortisone, and 9 mg benzyl alcohol as a preservative. The inactive ingredients are glacial acetic acid, phospholipon 90H (modified lecithin), polysorbate 20, polyvinyl alcohol, purified water, sodium acetate, and sodium chloride. Hydrochloric acid or sodium hydroxide may be added for adjustment of pH. Ciprofloxacin, a fluoroquinolone, is available as the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its empirical formula is C 17 H 18 FN 3 O 3 •HCI•H 2 O and its chemical structure is as follows: Hydrocortisone, pregn-4-ene-3, 20-dione, 11, 17, 21-trihydroxy-(11(β)-, is an anti-inflammatory corticosteroid. Its empirical formula is C 21 H 30 O 5 and its chemical structure is: Ciprofloxacin chemical structure Hydrocortisone chemical structure

cisatracurium besylate CISATRACURIUM BESYLATE
10 mg Injection
SANDOZ INC FDA Rx Only

Cisatracurium besylate is a nondepolarizing skeletal neuromuscular blocker for intravenous administration. Compared to other neuromuscular blockers, it is intermediate in its onset and duration of action. Cisatracurium besylate injection, USP contains cisatracurium besylate as the active pharmaceutical ingredient. Cisatracurium besylate is one of 10 isomers of atracurium besylate and constitutes approximately 15% of that mixture. Cisatracurium besylate is [1 R -[1α,2α(1' R *,2' R *)]]-2,2'-[1,5-pentanediylbis[oxy(3-oxo-3,1-propanediyl)]]bis[1-[(3,4-dimethoxyphenyl)methyl]-1,2,3,4-tetrahydro-6,7-dimethoxy-2-methylisoquinolinium] dibenzenesulfonate. The molecular formula of the cisatracurium parent bis-cation is C 53 H 72 N 2 O 12 and the molecular weight is 929.2. The molecular formula of cisatracurium as the besylate salt is C 65 H 82 N 2 O 18 S 2 and the molecular weight is 1243.50. The structural formula of cisatracurium besylate is: The log of the partition coefficient of cisatracurium besylate is -2.12 in a 1-octanol/distilled water system at 25°C. Cisatracurium besylate injection, USP is a sterile, non-pyrogenic aqueous solution. Each mL in the single-dose vials contains either 2 mg or 10 mg of cisatracurium (equivalent to 2.68 mg and 13.38 mg of cisatracurium besylate; respectively), and benzenesulfonic acid as pH adjuster in water for injection. The pH of cisatracurium besylate injection is between 3.25 to 3.65. chemical-structure

cisatracurium besylate CISATRACURIUM BESYLATE
20 mg Injection
SANDOZ INC FDA Rx Only

Cisatracurium besylate is a nondepolarizing skeletal neuromuscular blocker for intravenous administration. Compared to other neuromuscular blockers, it is intermediate in its onset and duration of action. Cisatracurium besylate injection, USP contains cisatracurium besylate as the active pharmaceutical ingredient. Cisatracurium besylate is one of 10 isomers of atracurium besylate and constitutes approximately 15% of that mixture. Cisatracurium besylate is [1 R - [1α,2α(1' R *,2' R *)]]-2,2'-[1,5-pentanediylbis[oxy(3-oxo-3,1-propanediyl)]]bis[1-[(3,4-dimethoxyphenyl)methyl]-1,2,3,4-tetrahydro-6,7-dimethoxy-2-methylisoquinolinium] dibenzenesulfonate. The molecular formula of the cisatracurium parent bis-cation is C 53 H 72 N 2 O 12 and the molecular weight is 929.2. The molecular formula of cisatracurium as the besylate salt is C 65 H 82 N 2 O 18 S 2 and the molecular weight is 1243.50. The structural formula of cisatracurium besylate is: The log of the partition coefficient of cisatracurium besylate is -2.12 in a 1-octanol/distilled water system at 25°C. Cisatracurium besylate injection, USP is a sterile, non-pyrogenic aqueous solution. Each mL in the multiple-dose vials contains 2 mg of cisatracurium (equivalent to 2.68 mg of cisatracurium besylate), benzenesulfonic acid as pH adjuster, and also contains 9 mg of benzyl alcohol as preservative, in water for injection. The pH of cisatracurium besylate injection is between 3.25 to 3.65. chemical-structure

Clindamycin in 5 Percent Dextrose CLINDAMYCIN IN 5 PERCENT DEXTROSE
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Clindamycin in 5% Dextrose Injection in the Cryovac plastic container for intravenous use is composed of clindamycin phosphate equivalent to 300, 600 and 900 mg of clindamycin premixed with 5% dextrose as a sterile solution. Disodium edetate has been added at a concentration of 0.04 mg/mL. The pH has been adjusted with sodium hydroxide and/or hydrochloric acid. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. The chemical name of clindamycin phosphate is L- threo-α -D- galacto - Octopyranoside, methyl-7-chloro-6,7,8-trideoxy-6-[[(1-methyl-4-propyl-2- pyrrolidinyl) carbonyl] amino]-1-thio-, 2-(dihydrogen phosphate), (2 S-trans )-. The molecular formula is C 18 H 34 CIN 2 0 8 PS and the molecular weight is 504.97. The structural formula is represented below: The plastic container is fabricated from a specially designed multilayer plastic, M312A material. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period. The suitability of the plastic has been confirmed in tests in animals according to the USP biological tests for plastic containers, as well as by tissue culture toxicity studies. structure-formula

Cosyntropin COSYNTROPIN
0.25 mg Injection
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Cosyntropin is an adrenocorticotropic hormone (ACTH). Cosyntropin is synthetic beta 1 - 24 corticotropin, a synthetic subunit of ACTH. It is an open chain polypeptide containing, the first 24 of the 39 amino acids of natural ACTH in sequence from N terminal. The sequence of amino acids in the 1 - 24 compound is as follows: Molecular Formula: C 136 H 210 N 40 O 31 S Molecular Weight: 2933 g/mol. Cosyntropin for injection is a sterile lyophilized powder in single-dose vials containing 0.25 mg of cosyntropin and 10 mg of mannitol. chemical-strucure

Cromolyn Sodium CROMOLYN SODIUM
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Cromolyn Sodium Ophthalmic Solution USP, 4% is a clear, colorless, sterile solution intended for topical ophthalmic use. Cromolyn sodium is represented by the following structural formula: Chemical Name: Disodium 5-5'-[(2-hydroxytrimethylene)dioxy]bis[4-oxo-4H-1-benzopyran-2-carboxylate] Pharmacologic Category: Mast cell stabilizer. EACH mL CONTAINS: Active: cromolyn sodium 40 mg (4%); Preservative: benzalkonium chloride 0.01%. Inactives: edetate disodium 0.1% and purified water. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH (4.0-7.0). chemicalstructure

Cyclopentolate Hydrochloride CYCLOPENTOLATE HYDROCHLORIDE
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Cyclopentolate Hydrochloride Ophthalmic Solution USP is an anticholinergic prepared as a sterile, borate buffered, solution for topical ocular use. It is supplied in three strengths. The active ingredient is represented by the structural formula: Established name: Cyclopentolate Hydrochloride Chemical name: 2-(Dimethylamino)ethyl 1-hydroxy-a-phenylcyclopentaneacetate hydrochloride Each mL of cyclopentolate hydrochloride ophthalmic solution, USP contains: Active: cyclopentolate hydrochloride 0.5%, 1% or 2%. Preservative: benzalkonium chloride 0.01%. Inactives: boric acid, edetate disodium, potassium chloride (except 2% strength), sodium carbonate and/or hydrochloric acid (to adjust pH), purified water. The pH range is between 3.0 and 5.5. chemical

Cyclophosphamide CYCLOPHOSPHAMIDE
100 mg/ml Injection
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Cyclophosphamide is an alkylating drug. It is a synthetic antineoplastic drug chemically related to the nitrogen mustards. The chemical name for cyclophosphamide is 2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate, and has the following structural formula: Cyclophosphamide is a white crystalline powder with the molecular formula C 7 H 15 Cl 2 N 2 O 2 P•H 2 O and a molecular weight of 279.1. Cyclophosphamide is soluble in water and freely soluble in alcohol. Cyclophosphamide Injection, 100 mg/mL is a sterile ready-to-dilute, clear, colorless to pale-yellow solution in a multiple-dose vial available as 500 mg/5 mL, 1,000 mg/10 mL, and 2,000 mg/20 mL strengths. • 500 mg vial contains 534.5 mg cyclophosphamide monohydrate equivalent to 500 mg cyclophosphamide, 2.92 g dehydrated alcohol (equivalent to 73.9 % v/v) and 0.96 g propylene glycol. • 1,000 mg vial contains 1,069 mg cyclophosphamide monohydrate equivalent to 1,000 mg cyclophosphamide, 5.85 g dehydrated alcohol (equivalent to 73.9 % v/v) and 1.92 g propylene glycol. • 2,000 mg vial contains 2,138 mg cyclophosphamide monohydrate equivalent to 2,000 mg cyclophosphamide, 11.69 g dehydrated alcohol (equivalent to 73.9 % v/v) and 3.84 g propylene glycol. chemical-structure

Cyclophosphamide CYCLOPHOSPHAMIDE
500 mg Injection
SANDOZ INC. FDA Rx Only

Cyclophosphamide is a synthetic antineoplastic drug chemically related to the nitrogen mustards. The chemical name for cyclophosphamide is 2-[bis(2-chloroethyl)amino] tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate, and has the following structural formula: Cyclophosphamide is a white crystalline powder with the molecular formula C 7 H 15 Cl 2 N 2 O 2 P•H 2 O and a molecular weight of 279.1. Cyclophosphamide is soluble in water, saline, or ethanol. Cyclophosphamide for Injection, USP is for intravenous or oral use, it has no inactive ingredients. When reconstituted in water Cyclophosphamide for Injection, USP has a pH range of 3.0 to 9.0. Cyclophosphamide for Injection, USP is a sterile white powder available as 500 mg, 1 g, and 2 g strength vials. 500 mg vial contains 534.5 mg cyclophosphamide monohydrate equivalent to 500 mg cyclophosphamide 1 g vial contains 1069.0 mg cyclophosphamide monohydrate equivalent to 1 g cyclophosphamide 2 g vial contains 2138.0 mg cyclophosphamide monohydrate equivalent to 2 g cyclophosphamide structure

Desflurane DESFLURANE
100 % Liquid
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Desflurane, USP, Liquid for Inhalation, a nonflammable liquid administered via vaporizer, is a general inhalation anesthetic. It is (±)1,2,2,2-tetrafluoroethyl difluoromethyl ether: Some physical constants are: Molecular weight 168.04 Specific gravity (at 20°C/4°C) 1.465 Vapor pressure in mmHg 669 mmHg @ 20°C 731 mmHg @ 22°C 757 mmHg @ 22.8°C (boiling point;1atm) 764 mmHg @ 23°C 798 mmHg @ 24°C 869 mmHg @ 26°C Partition coefficients at 37°C: Blood/Gas 0.424 Olive Oil/Gas 18.7 Brain/Gas 0.54 Mean Component/Gas Partition Coefficients: Polypropylene (Y piece) 6.7 Polyethylene (circuit tube) 16.2 Latex rubber (bag) 19.3 Latex rubber (bellows) 10.4 Polyvinylchloride (endotracheal tube) 34.7 Desflurane, USP is nonflammable as defined by the requirements of International Electrotechnical Commission 601-2-13. Desflurane, USP is a colorless, volatile liquid below 22.8°C. Data indicate that desflurane, USP is stable when stored under normal room lighting conditions according to instructions. Desflurane, USP is chemically stable. The only known degradation reaction is through prolonged direct contact with soda lime producing low levels of fluoroform (CHF 3 ). The amount of CHF 3 obtained is similar to that produced with MAC-equivalent doses of isoflurane. No discernible degradation occurs in the presence of strong acids. Desflurane, USP does not corrode stainless steel, brass, aluminum, anodized aluminum, nickel plated brass, copper, or beryllium. Structure

DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
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Dexmedetomidine hydrochloride in 0.9% sodium chloride injection (4 mcg per mL) is a sterile, nonpyrogenic ready to use solution suitable for intravenous infusion. Dexmedetomidine hydrochloride in 0.9% sodium chloride injection contains dexmedetomidine hydrochloride as the active pharmaceutical ingredient. Dexmedetomidine hydrochloride is a central alpha2-adrenergic agonist. Dexmedetomidine hydrochloride is the S-enantiomer of medetomidine. Dexmedetomidine hydrochloride chemical name is 1H-Imidazole, 4-[1-(2,3-dimethylphenyl)ethyl]-, monohydrochloride, (S). Dexmedetomidine hydrochloride has a molecular weight of 236.7 and the empirical formula is C 13 H 16 N 2 •HCl and the structural formula is: Dexmedetomidine hydrochloride is a white or almost white powder that is freely soluble in water and has a pKa of 7.1. Its partition coefficient in-octanol: water at pH 7.4 is 2.89. Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is ready to be used. It is supplied as a clear, colorless, isotonic solution with a pH between 4.5 to 7.0. Each mL contains 4.72 mcg of dexmedetomidine hydrochloride (equivalent to 4 mcg or 0.004 mg of dexmedetomidine) and 9 mg of sodium chloride in water for injection. The solution is preservative-free and contains no additives or chemical stabilizers. structure

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate DEXTROAMPHETAMINE SACCHARATE AMPHETAMINE ASPARTATE MONOHYDRATE DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE

MAS-ER Capsules contain mixed salts of a single-entity amphetamine, a CNS stimulant. MAS-ER Capsules contain equal amounts (by weight) of four salts: dextroamphetamine sulfate, amphetamine sulfate, dextroamphetamine saccharate and amphetamine (D, L)-aspartate monohydrate. This results in a 3.1:1 mixture of dextro- to levo-amphetamine base equivalent. The 5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg strength extended-release capsules are for oral administration. MAS-ER Capsules contain two types of drug-containing beads (immediate-release and delayed-release) which prolong the release of amphetamine compared to the Adderall (immediate-release) tablet formulation. Each capsule contains: Capsule Strength 5 mg 10 mg 15 mg 20 mg 25 mg 30 mg Dextroamphetamine Saccharate 1.25 mg 2.5 mg 3.75 mg 5.0 mg 6.25 mg 7.5 mg Amphetamine (D,L)-Aspartate Monohydrate 1.25 mg 2.5 mg 3.75 mg 5.0 mg 6.25 mg 7.5 mg Dextroamphetamine Sulfate 1.25 mg 2.5 mg 3.75 mg 5.0 mg 6.25 mg 7.5 mg Amphetamine Sulfate 1.25 mg 2.5 mg 3.75 mg 5.0 mg 6.25 mg 7.5 mg Total amphetamine base equivalence 3.1 mg 6.3 mg 9.4 mg 12.5 mg 15.6 mg 18.8 mg d -amphetamine base equivalence 2.4 mg 4.7 mg 7.1 mg 9.5 mg 11.9 mg 14.2 mg l -amphetamine base equivalence 0.75 mg 1.5 mg 2.3 mg 3.0 mg 3.8 mg 4.5 mg Inactive Ingredients and Colors The inactive ingredients in MAS-ER Capsules include: gelatin capsules, hydroxypropyl methylcellulose, methacrylic acid copolymer, opadry beige, sugar spheres, talc, and triethyl citrate. Gelatin capsules contain edible inks, kosher gelatin, and titanium dioxide. The 5, 10, and 15 mg capsules also contain FD&C Blue #2. The 20 mg, 25 mg, and 30 mg capsules also contain red iron oxide and yellow iron oxide.

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate DEXTROAMPHETAMINE SACCHARATE AMPHETAMINE ASPARTATE MONOHYDRATE DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE

A single-entity amphetamine product combining the neutral sulfate salts of dextroamphetamine and amphetamine, with the dextro isomer of amphetamine saccharate and d, l-amphetamine aspartate monohydrate. Each Tablet Contains 5 mg 10 mg 20 mg 30 mg Dextroamphetamine Saccharate 1.25 mg 2.5 mg 5 mg 7.5 mg Amphetamine Aspartate Monohydrate 1.25 mg 2.5 mg 5 mg 7.5 mg Dextroamphetamine Sulfate, USP 1.25 mg 2.5 mg 5 mg 7.5 mg Amphetamine Sulfate, USP 1.25 mg 2.5 mg 5 mg 7.5 mg Total Amphetamine Base Equivalence 3.13 mg 6.3 mg 12.6 mg 18.8 mg Inactive Ingredients: lactose monohydrate, pregelatinized starch (corn) and magnesium stearate. Color Additives: FD&C blue No. 1 aluminum lake (for 5 mg and 10 mg strengths) and FD&C yellow No. 6 aluminum lake (for 20 mg and 30 mg strengths).

Diclofenac Sodium DICLOFENAC SODIUM
SANDOZ INC FDA Rx Only

Diclofenac sodium ophthalmic solution, 0.1% is a sterile, topical, nonsteroidal, anti-inflammatory product for ophthalmic use. Diclofenac sodium is designated chemically as 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt, with an empirical formula of C 14 H 10 Cl 2 NO 2 Na. The structural formula of diclofenac sodium is: Diclofenac sodium ophthalmic solution, 0.1% is available as a sterile solution which contains diclofenac sodium 0.1% (1 mg/mL). Inactive Ingredients: polyoxyl 35 castor oil, boric acid, tromethamine, sorbic acid (2 mg/mL), edetate disodium (1 mg/mL), and purified water. Diclofenac sodium is a faintly yellow-white to light-beige, slightly hygroscopic crystalline powder. It is freely soluble in methanol, sparingly soluble in water, very slightly soluble in acetonitrile, and insoluble in chloroform and in 0.1N hydrochloric acid. Its molecular weight is 318.14. Diclofenac sodium ophthalmic solution, 0.1% is an iso-osmotic solution with an osmolality of about 300 mOsmol/1000 g, buffered at approximately pH 7.2. Diclofenac sodium ophthalmic solution, 0.1% has a faint characteristic odor of castor oil. chemical

Difluprednate Ophthalmic DIFLUPREDNATE OPHTHALMIC
SANDOZ INC FDA Rx Only

Difluprednate ophthalmic emulsion, 0.05% is a sterile, topical anti-inflammatory corticosteroid for ophthalmic use. The chemical name is 6α,9difluoro-11β,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 g/mol, and the empirical formula is C 27 H 34 F 2 O 7 . Each mL of difluprednate ophthalmic emulsion contains: Active: difluprednate 0.5 mg (0.05%); Inactives: boric acid, castor oil, edetate disodium, glycerin, polysorbate 80, sodium acetate, sodium hydroxide (to adjust the pH to 5.2 to 5.8), water for injection. Preservative: sorbic acid 0.1%. The emulsion is essentially isotonic with a tonicity of 304 to 411 mOsm/kg. ChemicalStructure

Digoxin DIGOXIN
500 mcg Injection
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Digoxin is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata . The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of 2 portions: a sugar and a cardenolide (hence “glycosides”). Digoxin is described chemically as (3β,5β,12β)-3-[( O -2,6-dideoxy-β- D-ribo -hexopyranosyl-(1→4)- O -2,6-dideoxy-β- D-ribo -hexopyranosyl-(1→4)-2,6-dideoxy-β- D-ribo -hexopyranosyl)oxy]-12,14-dihydroxy-card-20(22)-enolide. Its molecular formula is C 41 H 64 O 14 , its molecular weight is 780.95, and its structural formula is: Digoxin exists as clear to white odorless crystals or white, odorless crystalline powder that melts with decomposition above 230°C. The drug is practically insoluble in water and in ether; slightly soluble in diluted (50%) alcohol and in chloroform; and freely soluble in pyridine. Digoxin injection, USP is a sterile solution of digoxin for intravenous or intramuscular injection. Each mL contains: digoxin 0.25 mg, propylene glycol 40% (v/v), anhydrous ethanol 10% (v/v), dibasic sodium phosphate 0.3% (w/v) and anhydrous citric acid 0.08% (w/v) to adjust pH between 6.8 and 7.2, and water for injection. Dilution is not required. digoxin-chemical-structure

Docetaxel DOCETAXEL
20 mg/2 ml
SANDOZ INC. FDA Rx Only

Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine, N- tert -butyl ester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate. Docetaxel has the following structural formula: Docetaxel is a white to almost-white powder with an empirical formula of C 43 H 53 NO 14 , and a molecular weight of 807.88. It is highly lipophilic and practically insoluble in water. Docetaxel Injection is a clear, colorless to pale yellow solution. Docetaxel Injection is sterile, non-pyrogenic, and is available in multiple-dose vials, supplied as 20 mg/2 mL, 80 mg/8 mL and 160 mg/16 mL. Each mL of Docetaxel Injection contains 10 mg docetaxel, 275.9 mg alcohol 96% (v/v), 4 mg citric acid, 648 mg polyethylene glycol 300, and 80 mg polysorbate 80. chemical-structure

DORZOLAMIDE HYDROCHLORIDE DORZOLAMIDE HYDROCHLORIDE
SANDOZ INC FDA Rx Only

Dorzolamide hydrochloride ophthalmic solution is a carbonic anhydrase inhibitor formulated for topical ophthalmic use. Dorzolamide hydrochloride is described chemically as: (4 S - 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=1, water) = ~ -17°. 405 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 to 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. chemical-structure

Dorzolamide Hydrochloride and Timolol Maleate DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE
SANDOZ INC FDA Rx Only

Dorzolamide hydrochloride and timolol maleate ophthalmic solution is the combination of a topical carbonic anhydrase inhibitor and a topical beta-adrenergic receptor blocking agent. Dorzolamide hydrochloride is described chemically as: (4 S-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°. 405nm Its molecular 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 360.91. 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: [α] 25°C in 1N HCl (C = 5) = -12.2° (-11.7° to -12.5°). 405nm 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, 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 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 to 323 mOsM. Each mL of dorzolamide hydrochloride and timolol maleate ophthalmic solution contains 20 mg dorzolamide (equivalent to 22.26 mg of dorzolamide hydrochloride) and 5 mg timolol (equivalent to 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. chemicalstructureDorzol chemicalstructuretimolol

Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium DROSPIRENONE ETHINYL ESTRADIOL LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM

Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium provides an oral contraceptive regimen consisting of 28 film-coated tablets that contain the active ingredients specified for each tablet below: • 24 pink tablets each containing 3 mg DRSP, 0.02 mg EE as betadex clathrate, and 0.451 mg levomefolate calcium • 4 light orange tablets each containing 0.451 mg levomefolate calcium The inactive ingredients in the pink tablets are lactose monohydrate NF, microcrystalline cellulose NF, croscarmellose sodium NF, hydroxypropyl cellulose NF, magnesium stearate NF, hypromellose USP, titanium dioxide USP, talc USP, polyethylene glycol NF, ferric oxide pigment, red NF. The light orange film-coated tablets contain 0.451 mg of levomefolate calcium. The inactive ingredients in the light orange tablets are lactose monohydrate NF, microcrystalline cellulose NF, croscarmellose sodium NF, hydroxypropyl cellulose NF, magnesium stearate NF, hypromellose USP, titanium dioxide USP talc USP, polyethylene glycol NF, ferric oxide pigment, red NF, ferric oxide pigment, yellow NF. Drospirenone (6R,7R,8R,9S,10R,13S,14S,15S,16S,17S)-1,3',4',6,6a,7,8,9,10,11,12,13,14,15,15a,16-hexadecahydro-10,13-dimethylspiro-[17H-dicyclopropa- [6,7:15,16] cyclopenta[a]phenanthrene-17,2'(5H)-furan]-3,5'(2H)-dione) is a synthetic progestational compound and has a molecular weight of 366.5 and a molecular formula of C 24 H 30 O 3 . Ethinyl estradiol (19-nor-17α-pregna 1,3,5(10)-triene-20-yne-3, 17-diol) is a synthetic estrogenic compound and has a molecular weight of 296.4 and a molecular formula of C 20 H 24 O 2 . Levomefolate calcium (N-[4-[[(2-amino-1,4,5,6,7,8-hexahydro-5-methyl-4-oxo-(6S)-pteridinyl)methyl]amino]benzoyl]-L-glutamic acid, calcium salt) is a synthetic calcium salt of L-5-methyltetrahydrofolate (L-5-methyl-THF), which is a metabolite of vitamin B 9 and has a molecular weight of 497.5 and a molecular formula of C 20 H 23 CaN 7 O 6. The structural formulas are as follows: Structures

Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium DROSPIRENONE ETHINYL ESTRADIOL LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM

Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium provides an oral contraceptive regimen consisting of 28 film-coated tablets that contain the active ingredients specified for each tablet below: • 21 orange tablets each containing 3 mg DRSP, 0.03 mg EE as betadex clathrate, and 0.451 mg levomefolate calcium • 7 light orange tablets each containing 0.451 mg levomefolate calcium The inactive ingredients in the orange tablets are lactose monohydrate NF, microcrystalline cellulose NF, croscarmellose sodium NF, hydroxypropyl cellulose USP, magnesium stearate NF, hypromellose USP, titanium dioxide USP, talc USP, polyethylene glycol NF, ferric oxide pigment, yellow NF, and ferric oxide pigment, red NF. The light orange film-coated tablets contain 0.451 mg of levomefolate calcium. The inactive ingredients in the light orange tablets are lactose monohydrate NF, microcrystalline cellulose NF, croscarmellose sodium NF, hydroxypropyl cellulose NF, magnesium stearate NF, hypromellose USP, titanium dioxide USP, talc USP, polyethylene glycol NF and ferric oxide pigment, yellow NF, and ferric oxide pigment, red NF. Drospirenone (6R,7R,8R,9S,10R,13S,14S,15S,16S,17S)-1,3',4',6,6a,7,8,9,10,11,12,13, 14,15,15a,16-hexadecahydro-10,13-dimethylspiro-[17H-dicyclopropa-[6,7:15,16] cyclopenta[a]phenanthrene-17,2'(5H)-furan]-3,5'(2H)-dione) is a synthetic progestational compound and has a molecular weight of 366.5 and a molecular formula of C 24 H 30 O 3 . Ethinyl estradiol (19-nor-17α-pregna 1,3,5(10)-triene-20-yne-3,17-diol) is a synthetic estrogenic compound and has a molecular weight of 296.4 and a molecular formula of C 20 H 24 O 2 . Levomefolate calcium (N-[4-[[(2-amino-1,4,5,6,7,8-hexahydro-5-methyl-4-oxo-(6S)-pteridinyl)methyl]amino]benzoyl]-L-glutamic acid, calcium salt) is a synthetic calcium salt of L-5-methyltetrahydrofolate (L-5-methyl-THF), which is a metabolite of vitamin B 9 and has a molecular weight of 497.5 and a molecular formula of C 20 H 23 CaN 7 O 6. The structural formulas are as follows: Chem structure

DUREZOL DIFLUPREDNATE
SANDOZ INC FDA Rx Only

DUREZOL (difluprednate ophthalmic emulsion) 0.05% is a sterile, topical anti-inflammatory corticosteroid for topical ophthalmic use. The chemical name is 6α,9difluoro-11β,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 g/mol, and the empirical formula is C 27 H 34 F 2 O 7 . Each mL of DUREZOL contains: Active: difluprednate 0.5 mg (0.05%); Inactives: boric acid, castor oil, edetate disodium, glycerin, polysorbate 80, sodium acetate, sodium hydroxide (to adjust the pH to 5.2 to 5.8), water for injection. Preservative: sorbic acid 0.1%. The emulsion is essentially isotonic with a tonicity of 304 to 411 mOsm/kg. Difluprednate structural formula

Edaravone EDARAVONE
30 mg Injection
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The active ingredient in edaravone injection is edaravone, which is a member of the substituted 2-pyrazolin-5-one class. The chemical name of edaravone is [3-methyl-1-phenyl-2-pyrazolin-5-one]. Molecular formula: C 10 H 10 N 2 O Molecular weight: 174.20 Chemical structure: Edaravone is a white to yellowish powder with a melting point of 129.7°C. It is freely soluble in acetic acid, methanol, or ethanol and slightly soluble in water or diethyl ether. Edaravone injection is a clear, colorless, and free from visible particle liquid provided as a sterile solution. Edaravone injection is supplied for intravenous infusion in a polypropylene bag containing 30 mg edaravone in 100 mL isotonic, sterile, aqueous solution, which is further over-wrapped on the front with transparent Aten film and on the back with four-layer formable film as secondary packaging. The over-wrapped package also contains an oxygen absorber and oxygen indicator to minimize oxidation. Each bag contains the following inactive ingredients: L-cysteine hydrochloride hydrate (10 mg), sodium bisulfite (20 mg). Sodium chloride is added for isotonicity and phosphoric acid and sodium hydroxide are added to adjust to pH 4. chem-structure

Enoxaparin Sodium ENOXAPARIN SODIUM
100 mg/ml Injection
SANDOZ INC FDA Rx Only

Enoxaparin sodium injection, USP is a sterile aqueous solution containing enoxaparin sodium, a low molecular weight heparin. The pH of the injection is 5.5 to 7.5. Enoxaparin sodium is obtained by alkaline depolymerization of heparin benzyl ester derived from porcine intestinal mucosa. Its structure is characterized by a 2-O-sulfo-4-enepyranosuronic acid group at the non-reducing end and a 2-N,6-O-disulfo-D-glucosamine at the reducing end of the chain. About 20% (ranging between 15% and 25%) of the enoxaparin structure contains a 1,6 anhydro derivative on the reducing end of the polysaccharide chain. The drug substance is the sodium salt. The average molecular weight is about 4500 daltons. The molecular weight distribution is: <2000 daltons ≤20% 2000 to 8000 daltons ≥68% >8000 daltons ≤18% STRUCTURAL FORMULA Enoxaparin Sodium Injection, USP 100 mg/mL Concentration contains 10 mg enoxaparin sodium (approximate anti-Factor Xa activity of 1000 IU [with reference to the W.H.O. First International Low Molecular Weight Heparin Reference Standard]) per 0.1 mL Water for Injection. Enoxaparin Sodium Injection, USP 150 mg/mL Concentration contains 15 mg enoxaparin sodium (approximate anti-Factor Xa activity of 1500 IU [with reference to the W.H.O. First International Low Molecular Weight Heparin Reference Standard]) per 0.1 mL Water for Injection. The enoxaparin sodium injection, USP prefilled syringes and graduated prefilled syringes are preservative-free and intended for use only as a single-dose injection. [see Dosage and Administration ( 2 ) and How Supplied/Storage and Handling ( 16 ) ] . Enoxaparin Sodium Chemical Structure

Entacapone ENTACAPONE
SANDOZ INC FDA Rx Only

Entacapone is available as tablets containing 200 mg entacapone. Entacapone is an inhibitor of catechol- O -methyltransferase (COMT), used in the treatment of Parkinson’s disease as an adjunct to levodopa and carbidopa therapy. It is a nitrocatechol-structured compound with a relative molecular mass of 305.29. The chemical name of entacapone is (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethyl-2-propenamide. Its empirical formula is C 14 H 15 N 3 O 5 and its structural formula is: The inactive ingredients of the entacapone tablets are microcrystalline cellulose, mannitol, croscarmellose sodium, hydrogenated vegetable oil, hydroxypropyl methylcellulose, polysorbate 80, glycerol 85%, sucrose, magnesium stearate, yellow iron oxide, red iron oxide and titanium dioxide. Entacapone Chemical Structure

Ephedrine Sulfate EPHEDRINE SULFATE
1 ml Injection
SANDOZ INC FDA Rx Only

Ephedrine is an alpha- and beta-adrenergic agonist and a norepinephrine-releasing agent. Ephedrine sulfate injection, USP is a clear, colorless, sterile solution for intravenous injection. It must be diluted before intravenous administration. The chemical name of ephedrine sulfate is (1R,2S)-(-)-2-methylamine-1-phenylpropan-1-ol sulfate, and the molecular weight is 428.5 g/mol. Its structural formula is depicted below: Ephedrine sulfate is freely soluble in water and ethanol, very slightly soluble in chloroform, and practically insoluble in ether. Each mL contains ephedrine sulfate, USP 50 mg (equivalent to 38 mg ephedrine base) in water for injection. The pH is adjusted with sodium hydroxide and/or glacial acetic acid if necessary. The pH range is 4.5 to 7.0. chemical-structure

Eribulin Mesylate ERIBULIN MESYLATE
1 mg/2 ml Injection
SANDOZ INC FDA Rx Only

Eribulin mesylate injection contains eribulin mesylate, a microtubule dynamics inhibitor. Eribulin mesylate is a synthetic analogue of halichondrin B, a product isolated from the marine sponge Halichondria okadai . The chemical name for eribulin mesylate is 11,15:18,21:24,28-Triepoxy-7,9-ethano-12,15-methano-9 H ,15 H -furo[3,2- i ]furo[2',3':5,6]pyrano[4,3- b ][1,4]dioxacyclopentacosin-5(4 H )-one, 2-[(2 S )-3-amino-2-hydroxypropyl]hexacosahydro-3-methoxy-26-methyl-20,27-bis(methylene)-, (2 R ,3 R ,3a S ,7 R ,8a S ,9 S ,10a R ,11 S ,12 R ,13a R ,13b S ,15 S ,18 S ,21 S ,24 S ,26 R ,28 R ,29a S )-, methanesulfonate (salt). It has a molecular weight of 826.0 (729.9 for free base). The empirical formula is C 40 H 59 NO 11 •CH 4 O 3 S. Eribulin mesylate has the following structural formula: Eribulin mesylate injection is a clear, colorless, sterile solution for intravenous administration. Each single-dose vial contains 1 mg of eribulin mesylate in 2 mL of solution. Each mL of solution contains 0.5 mg of eribulin mesylate (equivalent to 0.44 mg eribulin) in dehydrated alcohol (5% v/v) and water for injection (95% v/v). Sodium hydroxide or hydrochloric acid may be used for pH adjustment. chemical_structure

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