sagent pharmaceuticals - Medication Listings

Browse 161 medications manufactured by sagent pharmaceuticals. Open a product record to review dosage forms, strengths, packaging, and related navigation.

Furosemide FUROSEMIDE
#13 10 mg/ml
SAGENT PHARMACEUTICALS FDA Rx Only

Furosemide is a diuretic which is an anthranilic acid derivative. Chemically, it is 4-chloro- N -furfuryl-5-sulfamoylanthranilic acid. Furosemide Injection, USP 10 mg/mL is a sterile, non-pyrogenic solution in vials for intravenous and intramuscular injection. 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 structural formula is as follows: Each mL contains: Furosemide 10 mg, Water for Injection q.s., Sodium Chloride for isotonicity, Sodium Hydroxide and, if necessary, Hydrochloric Acid to adjust pH between 8.0 and 9.3. Structural Formula

Furosemide FUROSEMIDE
#13 10 mg/ml
SAGENT PHARMACEUTICALS FDA Rx Only

Furosemide is a diuretic which is an anthranilic acid derivative. Chemically, it is 4-chloro- N -furfuryl-5-sulfamoylanthranilic acid. Furosemide injection, USP, 10 mg per mL is a sterile, nonpyrogenic solution in vials for intravenous and intramuscular injection. Furosemide, USP is a white to slightly yellow crystalline powder. It is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids. The structural formula is as follows: Molecular formula: C 12 H 11 ClN 2 O 5 S Molecular weight: 330.75 Each mL contains: Furosemide, USP 10 mg; Water for Injection q.s.; Sodium Chloride for isotonicity; Sodium Hydroxide and, if necessary, Hydrochloric Acid to adjust pH between 8.0 and 9.3. Structural Formula

Pantoprazole Sodium PANTOPRAZOLE SODIUM
#14 40 mg Injection
SAGENT PHARMACEUTICALS FDA Rx Only

The active ingredient in pantoprazole sodium for injection, a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1 H -benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C 16 H 14 F 2 N 3 NaO 4 S, with a molecular weight of 405.4. The structural formula is: Pantoprazole sodium USP is a white to off-white crystalline powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium, USP is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. The reconstituted solution of pantoprazole sodium for injection is in the pH range 9.0 to 10.5. Pantoprazole sodium for injection is supplied for intravenous administration as a sterile, freeze-dried powder in a single-dose clear glass vial fitted with a rubber stopper and crimp seal. Each vial contains 40 mg pantoprazole (equivalent to 45.1 mg of pantoprazole sodium), edetate disodium (1 mg), and sodium hydroxide to adjust pH. Structural Formula

Acetaminophen ACETAMINOPHEN
#34 1000 mg Injection
SAGENT PHARMACEUTICALS FDA Rx Only

Acetaminophen is a non-salicylate antipyretic and non-opioid analgesic agent. Its chemical name is N-acetyl-p-aminophenol. Acetaminophen has a molecular weight of 151.16. Its structural formula is: Acetaminophen Injection is a sterile, clear, colorless, non pyrogenic, isotonic formulation of acetaminophen intended for intravenous infusion. It has a pH of approximately 4.5 to 5.5 and an osmolality of approximately between 270 mOsm/kg and 310 mOsm/kg. Each 100 mL contains 1,000 mg Acetaminophen, USP, 3,800 mg Mannitol, USP, 30 mg Sodium Citrate Dihydrate USP, Water for Injection, USP qs. Each 50 mL contains 500 mg Acetaminophen, USP, 1,900 mg Mannitol, USP, 15 mg Sodium Citrate Dihydrate USP, Water for Injection, USP qs. pH is adjusted with glacial acetic acid. Structural Formula

Ciprofloxacin CIPROFLOXACIN
#39 5 % Injection
SAGENT PHARMACEUTICALS FDA Rx Only

Ciprofloxacin Injection, USP (in 5% Dextrose Injection) is a synthetic antimicrobial agent for intravenous (IV) administration. Ciprofloxacin, a fluoroquinolone, is 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 and its chemical structure is: Ciprofloxacin is a faint to light yellow crystalline powder with a molecular weight of 331.4. It is soluble in dilute (0.1N) hydrochloric acid and is practically insoluble in water and ethanol. Ciprofloxacin Injection, USP solution is a sterile 0.2% ready-for-use infusion solution in 5% Dextrose Injection. The formula contains lactic acid 0.644 mg per mL as a solubilizing agent and hydrochloric acid for pH adjustment. The pH range for the 0.2% ready-for-use infusion solutions is 3.5 to 4.6. The plastic container is not made with natural rubber latex and is fabricated from a specially formulated polyvinyl chloride. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, for example, Cyclohexanone and Chlorobenzene, up to 115 and 0.09 parts per million, respectively. The suitability of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies. The glucose content for the 100 mL bag is 5 g and 10 g for the 200 mL flexible container. Chemical Structure

Ciprofloxacin CIPROFLOXACIN
#39 5 % Injection
SAGENT PHARMACEUTICALS FDA Rx Only

Ciprofloxacin Injection, USP (in 5% Dextrose Injection) is a synthetic antimicrobial agent for intravenous (IV) administration. Ciprofloxacin, a fluoroquinolone, is 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 and its chemical structure is: Ciprofloxacin is a faint to light yellow crystalline powder with a molecular weight of 331.4. It is soluble in dilute (0.1N) hydrochloric acid and is practically insoluble in water and ethanol. Ciprofloxacin Injection, USP solution is a sterile 0.2% ready-for-use infusion solution in 5% Dextrose Injection. The formula contains lactic acid 0.644 mg per mL as a solubilizing agent and hydrochloric acid for pH adjustment. The pH range for the 0.2% ready-for-use infusion solutions is 3.5 to 4.6. The flexible container is fabricated from a specially formulated non-plasticized, thermoplastic copolyolephine. The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container's chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers. The glucose content for the 100 mL bag is 5 g and 10 g for the 200 mL flexible container. Chemical Structure

Acetazolamide ACETAZOLAMIDE SODIUM
SAGENT PHARMACEUTICALS FDA Rx Only

Acetazolamide USP, an inhibitor of the enzyme carbonic anhydrase is a white or almost white or faintly yellowish white powder, very slightly soluble in water; and in acetic acid. The chemical name for acetazolamide is N-(5-Sulfamoyl-1,3,4-thiadiazol-2-yl)acetamide and has the following chemical structure: Acetazolamide for injection, USP is available for intravenous use, and is supplied as a sterile powder requiring reconstitution. Each vial contains an amount of acetazolamide sodium equivalent to 500 mg of acetazolamide. The bulk solution is adjusted to pH 9.6 using sodium hydroxide and, if necessary, hydrochloric acid prior to lyophilization. structural formula

Acetylcysteine ACETYLCYSTEINE
6 g/30 ml Injection
SAGENT PHARMACEUTICALS FDA Rx Only

Acetylcysteine Injection is an intravenous antidote for the treatment of acetaminophen overdose. Acetylcysteine is the nonproprietary name for the N-acetyl derivative of the naturally occurring amino acid, L-cysteine (N-acetyl-L-cysteine,). The compound is a white crystalline powder, which melts in the range of 104° to 110°C and has a very slight odor. The molecular formula of the compound is C 5 H 9 NO 3 S, and its molecular weight is 163.2. Acetylcysteine has the following structural formula: Acetylcysteine Injection is supplied as a sterile solution in vials containing 20% w/v (200 mg per mL) acetylcysteine. The pH of the solution ranges from 6.0 to 7.5. Acetylcysteine Injection contains the following inactive ingredients: 0.5 mg per mL disodium edetate, sodium hydroxide (used for pH adjustment), and Water for Injection, USP. The amount of sodium in Acetylcysteine Injection is approximately 30 mg per mL. Because Acetylcysteine Injection is administered based on a patient's weight, the amount of sodium administered in a course of treatment will vary from approximately 225 mg to 4,500 mg. The use of ½ normal saline will contribute approximately an additional 1,770 mg of sodium per liter of diluent. Structural Formula

Acetylcysteine ACETYLCYSTEINE
200 mg/ml Injection
SAGENT PHARMACEUTICALS FDA Rx Only

Acetylcysteine Injection is an intravenous antidote for the treatment of acetaminophen overdose. Acetylcysteine is the nonproprietary name for the N-acetyl derivative of the naturally occurring amino acid, L-cysteine (N-acetyl-L-cysteine,). The compound is a white crystalline powder, which melts in the range of 104° to 110°C and has a very slight odor. The molecular formula of the compound is C 5 H 9 NO 3 S, and its molecular weight is 163.2. Acetylcysteine has the following structural formula: Acetylcysteine Injection is supplied as a sterile solution in vials containing 20% w/v (200 mg per mL) acetylcysteine. The pH of the solution ranges from 6.0 to 7.5. Acetylcysteine Injection contains the following inactive ingredients: 0.5 mg per mL disodium edetate, sodium hydroxide (used for pH adjustment), and Water for Injection, USP. Structural Formula

Adenosine ADENOSINE
3 mg/ml
SAGENT PHARMACEUTICALS FDA Rx Only

Adenosine is an endogenous nucleoside occurring in all cells of the body. It is chemically 6-amino-9-β-D-ribofuranosyl-9-H-purine and has the following structural formula: Adenosine is a white crystalline powder. It is soluble in water and practically insoluble in alcohol. Solubility increases by warming and lowering the pH. Adenosine is not chemically related to other antiarrhythmic drugs. Adenosine Injection is a sterile, nonpyrogenic solution for rapid bolus intravenous injection. Each mL contains 3 mg adenosine and 9 mg sodium chloride in Water for Injection. The pH of the solution is between 4.5 and 7.5. Structural Formula

adenosine ADENOSINE
3 mg/ml
SAGENT PHARMACEUTICALS FDA Rx Only

Adenosine is an endogenous nucleoside occurring in all cells of the body. It is chemically 6-amino-9-β-D-ribofuranosyl-9-H-purine and has the following structural formula: C 10 H 13 N 5 O 4 267.25 Adenosine is a white crystalline powder. It is soluble in water and practically insoluble in alcohol. Solubility increases by warming and lowering the pH. Adenosine is not chemically related to other antiarrhythmic drugs. Adenosine Injection, USP is a sterile solution for rapid bolus intravenous injection. Each mL contains 3 mg adenosine, USP and 9 mg sodium chloride, USP in water for injection, USP. The pH of the solution is between 4.5 and 7.5. Structural Formula

amikacin sulfate AMIKACIN SULFATE
SAGENT PHARMACEUTICALS FDA Rx Only

Amikacin sulfate is semi-synthetic aminoglycoside antibiotic derived from kanamycin. It is C 22 H 43 N 5 O 13 •2H 2 SO 4 • 0 -3-amino-3-deoxy-α-D-glucopyranosyl-(1→4)- O -[6-amino-6-deoxy-α-D-glucopyranosyl -(1→6)]- N 3 -(4-amino-L-2-hydroxybutyryl)-2-deoxy-L-streptamine sulfate (1:2) M.W. 781.76 The dosage form is supplied as a sterile, colorless to light straw colored solution for IM or IV use. The 500 mg per 2 mL vial and 1 gram per 4 mL vial contains per each mL: 250 mg amikacin (as the sulfate), 0.66% sodium metabisulfite, 2.5% sodium citrate dihydrate with pH adjusted to 4.5 with sulfuric acid. Chemical Structure

ampicillin AMPICILLIN
SAGENT PHARMACEUTICALS FDA Rx Only

Ampicillin for Injection, USP the monosodium salt of [2S-[2α, 5α, 6β(S*)]]-6- [(aminophenylacetyl)amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0]heptane-2-carboxylic acid, is a synthetic penicillin. It is an antibacterial agent with a broad spectrum of bactericidal activity against both penicillin-susceptible Gram-positive organisms and many common Gram-negative pathogens. Ampicillin for Injection, USP is a dry, white to off-white powder. The reconstituted solution is clear, colorless and free from visible particulates. Each vial of Ampicillin for Injection, USP contains ampicillin sodium equivalent to 1 gram or 2 grams ampicillin. Ampicillin for Injection, USP contains 65.8 mg [2.9 mEq] sodium per gram ampicillin. It has the following molecular structure: The molecular formula is C 16 H 18 N 3 NaO 4 S, and the molecular weight is 371.39. The pH range of the reconstituted solution is 8 to 10. Molecular Structure

ampicillin and sulbactam AMPICILLIN AND SULBACTAM
SAGENT PHARMACEUTICALS FDA Rx Only

Ampicillin and Sulbactam for Injection, USP is an injectable antibacterial combination consisting of the semisynthetic antibacterial ampicillin sodium and the beta-lactamase inhibitor sulbactam sodium for intravenous and intramuscular administration. Ampicillin sodium is derived from the penicillin nucleus, 6-aminopenicillanic acid. Chemically, it is monosodium (2S, 5R, 6R)-6-[(R)-2-amino-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0] heptane-2-carboxylate and has a molecular weight of 371.39. Its chemical formula is C 16 H 18 N 3 NaO 4 S. The structural formula is: Sulbactam sodium is a derivative of the basic penicillin nucleus. Chemically, sulbactam sodium is sodium penicillinate sulfone; sodium (2S, 5R)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0] heptane-2-carboxylate 4,4-dioxide. Its chemical formula is C 8 H 10 NNaO 5 S with a molecular weight of 255.22. The structural formula is: Ampicillin and Sulbactam for Injection, USP, ampicillin sodium/sulbactam sodium parenteral combination, is available as a white to off-white dry powder for reconstitution. Ampicillin and Sulbactam for Injection, USP dry powder is freely soluble in aqueous diluents to yield pale yellow to yellow solutions containing ampicillin sodium and sulbactam sodium equivalent to 250 mg ampicillin per mL and 125 mg sulbactam per mL. The pH of the solutions is between 8.0 and 10.0. Dilute solutions (up to 30 mg ampicillin and 15 mg sulbactam per mL) are essentially colorless to pale yellow. The pH of dilute solutions remains the same. 1.5 g of Ampicillin and Sulbactam for Injection, USP (1 g ampicillin as the sodium salt plus 0.5 g sulbactam as the sodium salt) parenteral contains approximately 115 mg (5 mEq) of sodium. 3 g of Ampicillin and Sulbactam for Injection, USP (2 g ampicillin as the sodium salt plus 1 g sulbactam as the sodium salt) parenteral contains approximately 230 mg (10 mEq) of sodium. Ampicillin Sodium Structural Formula Sulbactam Sodium Structural Formula

ampicillin and sulbactam AMPICILLIN AND SULBACTAM
SAGENT PHARMACEUTICALS FDA Rx Only

Ampicillin and Sulbactam for Injection, USP is an injectable antibacterial combination consisting of the semisynthetic antibacterial ampicillin sodium and the beta-lactamase inhibitor sulbactam sodium for intravenous and intramuscular administration. Ampicillin sodium is derived from the penicillin nucleus, 6-aminopenicillanic acid. Chemically, it is monosodium (2S, 5R, 6R)-6-[(R)-2-amino-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate and has a molecular weight of 371.39. Its chemical formula is C 16 H 18 N 3 NaO 4 S. The structural formula is: Sulbactam sodium is a derivative of the basic penicillin nucleus. Chemically, sulbactam sodium is sodium penicillinate sulfone; sodium (2S, 5R)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate 4,4-dioxide. Its chemical formula is C 8 H 10 NNaO 5 S with a molecular weight of 255.22. The structural formula is: Ampicillin and Sulbactam for Injection, USP, ampicillin sodium/sulbactam sodium parenteral combination, is available as a white to off-white dry powder for reconstitution. Ampicillin and Sulbactam for Injection, USP dry powder is freely soluble in aqueous diluents to yield pale yellow to yellow solutions containing ampicillin sodium and sulbactam sodium equivalent to 250 mg ampicillin per mL and 125 mg sulbactam per mL. The pH of the solutions is between 8 and 10. Dilute solutions (up to 30 mg ampicillin and 15 mg sulbactam per mL) are essentially colorless to pale yellow. The pH of dilute solutions remains the same. Each sterile Pharmacy Bulk Package contains 15 grams Ampicillin and Sulbactam for Injection, USP (equivalent to 10 grams ampicillin as the sodium salt plus 5 grams sulbactam as the sodium salt). The sodium content is approximately 1150 mg (50 mEq) sodium. Ampicillin and Sulbactam for Injection, USP Pharmacy Bulk Package is a bottle containing a sterile preparation of ampicillin sodium and sulbactam sodium for parenteral use that contains many single doses. The Pharmacy Bulk Package is for use in a pharmacy admixture setting; it provides many single doses of Ampicillin and Sulbactam for Injection, USP for addition to suitable parenteral fluids in the preparation of admixtures for intravenous infusion. (See DIRECTIONS FOR USE - Directions for Proper Use of Pharmacy Bulk Package .) FURTHER DILUTION IS REQUIRED BEFORE USE. Ampicillin Sodium Structural Formula Sulbactam Sodium Structural Formula

Ampicillin Sodium AMPICILLIN SODIUM
SAGENT PHARMACEUTICALS FDA Rx Only

Ampicillin for Injection, USP the monosodium salt of [2S-[2α,5α,6β(S*)]]-6-[(aminophenylacetyl) amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0]heptane-2-carboxylic acid, is a synthetic penicillin for intravenous use. The pharmacy bulk package contains sterile ampicillin sodium equivalent to 10 grams ampicillin. It is an antibacterial agent with a broad spectrum of bactericidal activity against both penicillin-susceptible Gram- positive organisms and many common Gram-negative pathogens. Ampicillin for Injection, USP is a dry, white to off-white powder. The reconstituted solution is clear, colorless and free from visible particulates. Each Pharmacy Bulk Package bottle contains ampicillin sodium equivalent to 10 grams of ampicillin. The sodium content is 65.8 mg (2.9 mEq) per one gram ampicillin. 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 ). It has the following molecular structure: The molecular formula is C 16 H 18 N 3 NaO 4 S, and the molecular weight is 371.39. The pH range of the reconstituted solution is 8 to 10. Molecular Structure

Argatroban ARGATROBAN
50 mg/50 ml Injection
SAGENT PHARMACEUTICALS FDA Rx Only

Argatroban is a synthetic direct thrombin inhibitor and the chemical name is 1-[5- [(aminoiminomethyl)amino]-1-oxo-2-[[(1,2,3,4-tetrahydro-3-methyl-8-quinolinyl)sulfonyl]amino]pentyl]-4-methyl-2-piperidinecarboxylic acid, monohydrate. Argatroban has 4 asymmetric carbons. One of the asymmetric carbons has an R configuration (stereoisomer Type I) and an S configuration (stereoisomer Type II). Argatroban consists of a mixture of R and S stereoisomers at a ratio of approximately 65:35. The molecular formula of argatroban is C 23 H 36 N 6 O 5 S•H 2 O. Its molecular weight is 526.66 g/mol. The structural formula is shown below: Argatroban is a white, odorless crystalline powder that is freely soluble in glacial acetic acid, slightly soluble in ethanol, and insoluble in acetone, ethyl acetate, and ether. Argatroban Injection 50 mg per 50 mL (1 mg per mL) is a sterile clear, colorless to pale yellow, solution. Argatroban 50 mg per 50 mL (1 mg per mL) is available in 50-mg (in 50-mL) single-dose clear vials, with flip-off seals. Each mL of sterile, nonpyrogenic solution contains 1 mg Argatroban. Inert ingredients (per vial): 260 mg Propylene glycol, 152 mg Dehydrated alcohol, and 450 mg Sodium Chloride. Structural Formula

Arsenic Trioxide ARSENIC TRIOXIDE
10 mg/10 ml Injection
SAGENT PHARMACEUTICALS FDA Rx Only

Arsenic trioxide injection is a sterile injectable solution of arsenic trioxide. The molecular formula of arsenic trioxide in the solid state is As 2 O 3 , with a molecular weight of 197.8 and the following structural formula: Arsenic trioxide injection is available in 10 mL, single-dose vials containing 10 mg or 12 mg of arsenic trioxide. Arsenic trioxide injection is formulated as a sterile, nonpyrogenic, clear solution of arsenic trioxide in water for injection using sodium hydroxide and dilute hydrochloric acid to adjust to pH 8. Arsenic trioxide injection is preservative-free. Arsenic trioxide, the active ingredient, is present at a concentration of 1 mg per mL and 2 mg per mL. Inactive ingredients and their respective approximate concentrations are sodium hydroxide (1.2 mg per mL) for solubilization, and sodium hydroxide and hydrochloric acid for pH adjustment to pH 8. Structural Formula

Azithromycin AZITHROMYCIN MONOHYDRATE
SAGENT PHARMACEUTICALS FDA Rx Only

Azithromycin for Injection, USP contains the active ingredient azithromycin, an azalide, a subclass of macrolide antibacterial drug, for intravenous injection. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R) -13-[(2,6-dideoxy-3- C -methyl-3- O- methyl-α- L-ribo -hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-hepta-methyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β- D - xylo -hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C 38 H 72 N 2 O 12 , and its molecular weight is 749. Azithromycin has the following structural formula: Azithromycin, as the monohydrate, is a white crystalline powder with a molecular formula of C 38 H 72 N 2 O 12 ·• H 2 O and a molecular weight of 767. Azithromycin for Injection, USP consists of azithromycin monohydrate USP and the following inactive ingredients: citric acid and sodium hydroxide. Sodium hydroxide is added to adjust the pH. Azithromycin for Injection, USP is supplied as white to off-white lyophilized powder in a single-dose vial for intravenous administration. Each vial contains azithromycin monohydrate USP equivalent to 500 mg of azithromycin, 384.5 mg citric acid, and sodium hydroxide. Reconstitution, according to label directions, results in approximately 5 mL of azithromycin for intravenous injection with each mL containing azithromycin monohydrate USP equivalent to 100 mg of azithromycin, 76.9 mg citric acid, and sodium hydroxide. Structural Formula

Azithromycin AZITHROMYCIN MONOHYDRATE
SAGENT PHARMACEUTICALS FDA Rx Only

Azithromycin for Injection, USP contains the active ingredient azithromycin, an azalide, a subclass of macrolide antibacterial drug, for intravenous injection. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R) -13-[(2,6-dideoxy-3- C -methyl-3- O- methyl-α- L-ribo -hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-hepta-methyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β- D - xylo -hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C 38 H 72 N 2 O 12 , and its molecular weight is 749. Azithromycin has the following structural formula: Azithromycin, as the monohydrate, is a white crystalline powder with a molecular formula of C 38 H 72 N 2 O 12 ·• H 2 O and a molecular weight of 767. Azithromycin for Injection, USP consists of azithromycin monohydrate USP and the following inactive ingredients: citric acid and sodium hydroxide. Sodium hydroxide is added to adjust the pH. Azithromycin for Injection, USP is supplied as white to off-white lyophilized powder in a single-dose vial for intravenous administration. Each vial contains azithromycin monohydrate USP equivalent to 500 mg of azithromycin, 384.5 mg citric acid, and sodium hydroxide. Reconstitution, according to label directions, results in approximately 5 mL of azithromycin for intravenous injection with each mL containing azithromycin monohydrate USP equivalent to 100 mg of azithromycin, 76.9 mg citric acid, and sodium hydroxide. Figure

Baclofen BACLOFEN
50 mcg/ml
SAGENT PHARMACEUTICALS FDA Rx Only

Baclofen Injection, USP* is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl) butanoic acid, and its structural formula is: Baclofen is a white to off-white, odorless or practically odorless crystalline powder, with a molecular weight of 213.66. It is slightly soluble in water, very slightly soluble in methanol, and insoluble in chloroform. Baclofen Injection, USP* is a sterile, nonpyrogenic, isotonic solution free of antioxidants, preservatives or other potentially neurotoxic additives indicated only for intrathecal administration. The drug is stable in solution at 37° C and compatible with CSF. Each milliliter of Baclofen Injection contains baclofen USP, 50 mcg and sodium chloride 9 mg in Water for Injection; pH range is 5.0 to 7.0. Each prefilled syringe is intended for SINGLE DOSE ONLY. Discard any unused portion. DO NOT AUTOCLAVE . Structural Formula

Baclofen BACLOFEN
1000 mcg Injection
SAGENT PHARMACEUTICALS FDA Rx Only

Baclofen injection, USP* is a muscle relaxant and antispastic. Baclofen's pharmacological class is a gamma-aminobutyric acid (GABA) ergic agonist. Baclofen's chemical name is 4-amino- 3-(4- chlorophenyl) butanoic acid, and its structural formula is: Baclofen Baclofen is a white to off-white, odorless or practically odorless crystalline powder, with a molecular weight of 213.66. It is slightly soluble in water, very slightly soluble in methanol, and insoluble in chloroform. Structural Formula

Baclofen BACLOFEN
500 mcg/ml
SAGENT PHARMACEUTICALS FDA Rx Only

Baclofen injection (intrathecal), USP* is a muscle relaxant and antispastic. Its chemical name is 4-amino-3- (4-chlorophenyl) butanoic acid, and its structural formula is: Baclofen is a white to off-white, odorless or practically odorless crystalline powder, with a molecular weight of 213.66. It is slightly soluble in water, very slightly soluble in methanol, and insoluble in chloroform. Baclofen injection (intrathecal), USP* is a sterile, nonpyrogenic, isotonic solution free of antioxidants, preservatives or other potentially neurotoxic additives indicated only for intrathecal administration. The drug is stable in solution at 37° C and compatible with CSF. Each milliliter of baclofen injection (intrathecal) contains baclofen U. S. P., 500 mcg or 2,000 mcg and sodium chloride 9 mg in Water for Injection; pH range is 5.0 to 7.0. Each vial is intended for SINGLE USE ONLY. Discard any unused portion. DO NOT AUTOCLAVE . Structural Formula

BORTEZOMIB BORTEZOMIB
3.5 mg Injection
SAGENT PHARMACEUTICALS FDA Rx Only

Bortezomib for Injection, a proteasome inhibitor, contains bortezomib which is an antineoplastic agent. Bortezomib is a modified dipeptidyl boronic acid. The chemical name for bortezomib, the monomeric boronic acid, is [(1R)-3-methyl-1-[[(2S)-1-oxo-3-phenyl-2-[(pyrazinylcarbonyl) amino]propyl]amino]butyl] boronic acid. Bortezomib has the following chemical structure: The molecular weight is 384.24. The molecular formula is C 19 H 25 BN 4 O 4 . The solubility of bortezomib, as the monomeric boronic acid, in water is 3.3 to 3.8 mg/mL in a pH range of 2 to 6.5. Bortezomib for Injection is available for intravenous injection or subcutaneous use. Each single-dose vial contains 3.5 mg of bortezomib as a sterile lyophilized powder. It also contains the inactive ingredient: 35 mg mannitol, USP. The product is provided as a mannitol boronic ester which, in reconstituted form, consists of the mannitol ester in equilibrium with its hydrolysis product, the monomeric boronic acid. The drug substance exists in its cyclic anhydride form as a trimeric boroxine. Chemical Structure

Bumetanide BUMETANIDE
0.25 mg/ml
SAGENT PHARMACEUTICALS FDA Rx Only

Bumetanide is a loop diuretic, available as 4 mL vials and 10 mL vials (0.25 mg per mL), for intravenous or intramuscular injection as a sterile solution. Each mL contains bumetanide 0.25 mg, sodium chloride 8.5 mg and ammonium acetate 4 mg as buffers, edetate disodium 0.1 mg and benzyl alcohol 10 mg as preservative in Water for Injection. pH adjusted to 6.8 to 7.8 with sodium hydroxide. Chemically, bumetanide is 3-(butylamino)-4-phenoxy-5-sulfamoylbenzoic acid. It is a practically white powder, slightly soluble in water, soluble in alkaline solutions, having the following structural formula: C 17 H 20 N 2 O 5 S Molecular weight: 364.42 Structural Formula

Busulfan BUSULFAN
60 mg/10 ml Injection
SAGENT PHARMACEUTICALS FDA Rx Only

Busulfan is a bifunctional alkylating agent known chemically as 1,4-butanediol, dimethanesulfonate. The molecular formula of busulfan is CH 3 SO 2 O(CH 2 ) 4 OSO 2 CH 3 with a molecular weight of 246 g/mole. Busulfan has the following chemical structure: Busulfan Injection (busulfan) is supplied as a clear, colorless, sterile, solution in 10 mL single-dose vials for intravenous administration upon dilution. Each vial contains 60 mg of busulfan in N,N-dimethylacetamide (DMA), 3.3 mL and Polyethylene Glycol 400, NF 6.7 mL. The solubility of busulfan in water is 0.1 g per L and the pH of Busulfan Injection diluted to approximately 0.5 mg per mL busulfan in 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP as recommended for infusion reflects the pH of the diluent used and ranges from 3.4 to 3.9. Chemical Structure

caffeine citrate CAFFEINE CITRATE
SAGENT PHARMACEUTICALS FDA Rx Only

Both Caffeine Citrate Injection, USP for intravenous administration and Caffeine Citrate Oral Solution, USP are clear, colorless, sterile, non-pyrogenic, preservative-free, aqueous solutions adjusted to pH 4.7. Each mL contains 20 mg caffeine citrate (equivalent to 10 mg of caffeine base) prepared in solution by the addition of 10 mg caffeine anhydrous to 5 mg citric acid monohydrate, 8.3 mg sodium citrate dihydrate and Water for Injection, USP. Caffeine, a central nervous system stimulant, is an odorless white crystalline powder or granule, with a bitter taste. It is sparingly soluble in water and ethanol at room temperature. The chemical name of caffeine is 3,7-dihydro-1,3,7-trimethyl-1 H -purine-2,6-dione. In the presence of citric acid it forms caffeine citrate salt in solution. The structural formula and molecular weight of caffeine citrate follows. Caffeine citrate C 14 H 18 N 4 O 9 MW 386.31 Structural Formula

Calcitonin Salmon CALCITONIN SALMON
2 ml Injection
SAGENT PHARMACEUTICALS FDA Rx Only

Calcitonin is a polypeptide hormone secreted by the parafollicular cells of the thyroid gland in mammals and by the ultimobranchial gland of birds and fish. Calcitonin Salmon Injection, USP Synthetic is a synthetic polypeptide of 32 amino acids in the same linear sequence that is found in calcitonin of salmon origin. This is shown by the following graphic formula: It is provided in sterile solution for subcutaneous or intramuscular injection. Each milliliter contains: calcitonin salmon 200 USP Units. Inactive Ingredients (per mL): acetic acid, USP, 2.25 mg; phenol, USP, 5 mg; sodium acetate trihydrate, USP, 2 mg; sodium chloride, USP, 7.5 mg; water for injection, USP. The activity of Calcitonin Salmon Injection, USP Synthetic is stated in International Units based on bioassay in comparison with the International Reference Preparation of calcitonin salmon for Bioassay, distributed by the National Institute for Biological Standards and Control, Holly Hill, London. structural formula

Carboprost Tromethamine CARBOPROST TROMETHAMINE
SAGENT PHARMACEUTICALS FDA Rx Only

Carboprost tromethamine injection, USP is a sterile solution, an oxytocic, contains the tromethamine salt of the (15S)-15 methyl analogue of naturally occurring prostaglandin F2α in a solution suitable for intramuscular injection. Carboprost tromethamine is the established name for the active ingredient in carboprost tromethamine injection, USP. Four other chemical names are: (15S)-15-methyl prostaglandin F2α tromethamine salt 7-(3α,5α-dihydroxy-2ß-[(3S)-3-hydroxy-3-methyl- trans -1-octenyl]-1α-cyclopentyl]- cis -5-heptenoic acid compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (15S)-9α,11α,15-trihydroxy-15-methylprosta- cis -5, trans -13-dienoic acid tromethamine salt (15S)-15-methyl PGF2α-THAM The structural formula is represented below: The molecular formula is C 25 H 47 O 8 N. The molecular weight of carboprost tromethamine is 489.64. It is a white to slightly off-white crystalline powder. It generally melts between 95° and 105°C, depending on the rate of heating. Carboprost tromethamine dissolves readily in water at room temperature at a concentration greater than 75 mg per mL. Each mL of carboprost tromethamine injection, USP sterile solution contains carboprost tromethamine equivalent to 250 mcg of carboprost, 83 mcg tromethamine, 9 mg sodium chloride, and 9.45 mg benzyl alcohol added as preservative. When necessary, pH is adjusted with sodium hydroxide and/or hydrochloric acid. The solution is sterile. Structural Formula

Caspofungin Acetate CASPOFUNGIN ACETATE
50 mg Injection
SAGENT PHARMACEUTICALS 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-[(4 R ,5 S )-5-[(2-aminoethyl)amino]- N 2 -(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 vial contains 50 mg of caspofungin equivalent to 55.5 mg of caspofungin acetate. Caspofungin acetate for injection 50 mg vial 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 vial contains 70 mg of caspofungin equivalent to 77.7 mg of caspofungin acetate. Caspofungin acetate for injection 70 mg vial 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: Structural Formula

cefazolin CEFAZOLIN SODIUM
SAGENT PHARMACEUTICALS FDA Rx Only

Cefazolin for Injection, USP is a semi-synthetic cephalosporin for parenteral administration. It is the sodium salt of 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: The pH of the reconstituted solution is between 4 and 6. Cefazolin for Injection, USP is a sterile white to cream powder supplied in vials. Each vial contains, cefazolin sodium equivalent to 500 mg or 1 gram of cefazolin. The sodium content is approximately 24 mg (1 mEq)/500 mg of cefazolin sodium or approximately 48 mg (2.1 mEq)/1 gram of cefazolin sodium. The color of Cefazolin for Injection, USP solutions may range from pale yellow to yellow without a change in potency. Cefazolin for Injection, USP is to be administered by intramuscular or intravenous routes. Structural Formula

cefepime CEFEPIME HYDROCHLORIDE
SAGENT PHARMACEUTICALS FDA Rx Only

Cefepime for Injection, USP is a semi-synthetic, cephalosporin antibacterial for parenteral administration. The chemical name is 1-[[(6R,7R)-7-[2-(2-amino-4-thiazolyl)-glyoxylamido]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0] oct-2-en-3-yl]methyl]-1-methylpyrrolidinium chloride,7 2 -(Z)-(O-methyloxime), monohydrochloride, monohydrate, which corresponds to the following structural formula: Cefepime hydrochloride is a white to pale yellow powder. Cefepime hydrochloride contains the equivalent of not less than 825 mcg and not more than 911 mcg of cefepime (C 19 H 24 N 6 O 5 S 2 ) per mg, calculated on an anhydrous basis. It is highly soluble in water. Cefepime for Injection, USP is supplied for intramuscular or intravenous administration in strengths equivalent to 1 gram and 2 grams of cefepime. Cefepime for Injection, USP is a sterile, dry mixture of cefepime hydrochloride and L-arginine. The L-arginine, at an approximate concentration of 707 mg/g of cefepime, is added to control the pH of the constituted solution at 4 to 6. Freshly constituted solutions of Cefepime for Injection, USP will range in color from pale yellow to amber. Structural Formula

Cefoxitin CEFOXITIN
SAGENT PHARMACEUTICALS FDA Rx Only

Cefoxitin for Injection, USP contains cefoxitin sodium a semi-synthetic, broad-spectrum cephalosporin antibiotic for parenteral administration. It is derived from cephalosporin C, which is produced by Cephalosporium Acremonium . Its chemical name is sodium (6 R , 7 S )-3-(hydroxymethyl)-7-methoxy-8-oxo-7-[2-(2-thienyl)acetamido]-5-thia-1-azabicyclo [4.2.0]oct-2-ene-2-carboxylate carbamate (ester). The molecular formula is C 16 H 16 N 3 NaO 7 S 2 , and the structural formula is: Cefoxitin for Injection, USP is supplied as a dry powder in vials and contains approximately 53.8 mg (2.3 milliequivalents) of sodium per gram of cefoxitin activity. Solutions of Cefoxitin for Injection, USP range from colorless to light amber in color. The pH of freshly constituted solutions usually ranges from 4.2 to 7. Each pharmacy bulk package bottle contains sterile cefoxitin sodium, USP equivalent to 10 g of cefoxitin and is intended for intravenous infusion only. 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 service and are restricted to the preparation of admixtures for intravenous infusion. FURTHER DILUTION IS REQUIRED BEFORE USE. RECONSTITUTED BULK SOLUTION SHOULD NOT BE USED FOR DIRECT INFUSION. RECONSTITUTED STOCK SOLUTION MUST BE TRANSFERRED AND FURTHER DILUTED FOR I.V. INFUSION. Structural Formula

Cefoxitin CEFOXITIN
SAGENT PHARMACEUTICALS FDA Rx Only

Cefoxitin for Injection, USP contains cefoxitin sodium a semi-synthetic, broad-spectrum cephalosporin antibiotic for parenteral administration. It is derived from cephalosporin C, which is produced by Cephalosporium Acremonium . It is the sodium salt of 3-(hydroxymethyl)-7-methoxy-8-oxo-7-[2-(2-thienyl)acetamido]-5-thia-1-azabicyclo [4.2.0] oct-2-ene-2-carboxylate carbamate (ester). The molecular formula is C 16 H 16 N 3 NaO 7 S 2 , and the structural formula is: Cefoxitin for Injection, USP contains approximately 53.8 mg (2.3 milliequivalents) of sodium per gram of cefoxitin activity. Solutions of Cefoxitin for Injection, USP range from colorless to light amber in color. The pH of freshly constituted solutions usually ranges from 4.2 to 7.0. Each conventional vial contains sterile cefoxitin sodium, USP equivalent to 1 g or 2 g cefoxitin. Structural Formula

Ceftazidime CEFTAZIDIME
SAGENT PHARMACEUTICALS FDA Rx Only

Ceftazidime is a semisynthetic, broad-spectrum, beta-lactam antibacterial drug for parenteral administration. It is the pentahydrate of pyridinium, 1-[[7-[[(2-amino-4-thiazolyl)[(1-carboxy-1-methylethoxy)imino]acetyl]amino]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en-3-yl]methyl]-, hydroxide, inner salt, [6R-[6α,7β(Z)]]. It has the following structural formula: The molecular formula is C 22 H 22 N 6 O 7 S 2 •5H 2 O, representing a molecular weight of 636.65. Ceftazidime for injection, USP is a sterile, dry-powdered mixture of ceftazidime pentahydrate and sodium carbonate. The sodium carbonate at a concentration of 118 mg/g of ceftazidime activity has been admixed to facilitate dissolution. The total sodium content of the mixture is approximately 54 mg (2.3 mEq)/g of ceftazidime activity. Ceftazidime for injection, USP in sterile crystalline form is supplied in single-dose vials equivalent to 1 g or 2 g of anhydrous ceftazidime. Ceftazidime for injection, USP is a white to cream-colored crystalline powder. Solutions of ceftazidime for injection, USP range in color from light yellow to amber, depending on the diluent and volume used. The pH of freshly constituted solutions usually ranges from 5 to 8. Structural Formula

Ceftazidime CEFTAZIDIME
SAGENT PHARMACEUTICALS FDA Rx Only

Ceftazidime is a semisynthetic, broad-spectrum, beta-lactam antibacterial drug for parenteral administration. It is the pentahydrate of pyridinium, 1-[[7-[[(2-amino-4-thiazolyl)[(1-carboxy-1-methylethoxy)imino]acetyl]amino]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en-3-yl]methyl]-, hydroxide, inner salt, [6R-[6α,7β(Z)]]. It has the following structural formula: The molecular formula is C 22 H 22 N 6 O 7 S 2 •5H 2 O, representing a molecular weight of 636.65. Ceftazidime for injection, USP is a sterile, dry-powdered mixture of ceftazidime pentahydrate and sodium carbonate. The sodium carbonate at a concentration of 118 mg/g of ceftazidime activity has been admixed to facilitate dissolution. The total sodium content of the mixture is approximately 54 mg (2.3 mEq)/g of ceftazidime activity. Ceftazidime for injection, USP is a white to cream-colored crystalline powder. Solutions of ceftazidime for injection, USP range in color from light yellow to amber, depending on the diluent and volume used. The pH of freshly constituted solutions usually ranges from 5 to 8. Ceftazidime for injection, USP in sterile crystalline form is supplied in 6 gram Pharmacy Bulk Package bottles equivalent to 6 grams of anhydrous ceftazidime. The Pharmacy Bulk Package bottle contains 708 mg of sodium carbonate. The sodium content is approximately 54 mg (2.3 mEq) per gram of ceftazidime. The 6 g Pharmacy Bulk Package bottle is a container of 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 use. THE 6 g PHARMACY BULK PACKAGE IS NOT FOR DIRECT INFUSION. FURTHER DILUTION IS REQUIRED BEFORE USE (see DOSAGE AND ADMINISTRATION-Directions for Proper Use of Pharmacy Bulk Package ). Structural Formula

ceftriaxone CEFTRIAXONE
SAGENT PHARMACEUTICALS 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 for Injection, USP is a white to yellowish-orange 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 for Injection, USP solutions ranges from light yellow to amber, depending on the length of storage, concentration and diluent used. Ceftriaxone for Injection, USP contains approximately 83 mg (3.6 mEq) of sodium per gram of ceftriaxone activity. Structural Formula

Cefuroxime sodium CEFUROXIME SODIUM
SAGENT PHARMACEUTICALS FDA Rx Only

Cefuroxime is a sterile semisynthetic, broad-spectrum, cephalosporin antibiotic for parenteral administration. It is the sodium salt of (6R,7R)-3-[(carbamoyloxy)methyl]-7-[[(Z)-(furan-2-yl) (methoxyimino)acetyl] amino]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate, and it has the following chemical structure: The empirical formula is C 16 H 15 N 4 NaO 8 S, representing a molecular weight of 446.37. Cefuroxime for Injection, USP contains approximately 54.2 mg (2.4 mEq) of sodium per gram of cefuroxime activity. Cefuroxime for Injection, USP in sterile crystalline form is supplied in vials equivalent to 750 mg or 1.5 g of cefuroxime as cefuroxime sodium. Solutions of Cefuroxime for Injection, USP range in color from light yellow to amber, depending on the concentration and diluent used. The pH of freshly constituted solutions usually ranges from 6 to 8.5. Chemical Structure

chlorothiazide sodium CHLOROTHIAZIDE SODIUM
SAGENT PHARMACEUTICALS FDA Rx Only

Chlorothiazide Sodium for Injection, USP is a diuretic and antihypertensive. It is 6-chloro-2 H -1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide monosodium salt and its molecular weight is 317.71. Its empirical formula is C 7 H 5 ClN 3 NaO 4 S 2 and its structural formula is: Chlorothiazide Sodium for Injection, USP is a sterile lyophilized white powder and is supplied in a vial containing: Chlorothiazide sodium equivalent to chlorothiazide 500 mg, and the inactive ingredient mannitol 250 mg with sodium hydroxide to adjust pH. Chlorothiazide is a diuretic and antihypertensive. It is 6-chloro-2 H -1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C 7 H 6 ClN 3 O 4 S 2 and its structural formula is: It is a white, or practically white, crystalline powder with a molecular weight of 295.72, which is very slightly soluble in water, but readily soluble in dilute aqueous sodium hydroxide. It is soluble in urine to the extent of about 150 mg per 100 mL at pH 7. Structural Formula Structural Formula

chlorothiazide sodium CHLOROTHIAZIDE SODIUM
SAGENT PHARMACEUTICALS FDA Rx Only

Chlorothiazide Sodium for Injection, USP is a diuretic and antihypertensive. It is 6-chloro-2 H -1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide monosodium salt and its molecular weight is 317.71. Its empirical formula is C 7 H 5 ClN 3 NaO 4 S 2 and its structural formula is: Chlorothiazide Sodium for Injection, USP is a sterile lyophilized white powder and is supplied in a vial containing: Chlorothiazide sodium equivalent to chlorothiazide 500 mg, and the inactive ingredient mannitol 250 mg with sodium hydroxide to adjust pH. Chlorothiazide is a diuretic and antihypertensive. It is 6-chloro-2 H -1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C 7 H 6 ClN 3 O 4 S 2 and its structural formula is: It is a white, or practically white, crystalline powder with a molecular weight of 295.72, which is very slightly soluble in water, but readily soluble in dilute aqueous sodium hydroxide. It is soluble in urine to the extent of about 150 mg per 100 mL at pH 7. Chlorothiazide Sodium Structural Formula Chlorothiazide Structural Formula

Cisplatin CISPLATIN
1 mg/ml
SAGENT PHARMACEUTICALS FDA Rx Only

Cisplatin Injection is a clear, colorless to pale yellow solution. Each 100 mL amber vial of Cisplatin Injection contains: 1 mg per mL cisplatin USP, 9 mg per mL sodium chloride, hydrochloric acid and/or sodium hydroxide to adjust pH, and water for injection USP to a final volume of 50 mL and 100 mL respectively. The pH range of Cisplatin Injection is 3.8 to 5.9. Cisplatin Injection must be further diluted prior to administration (see DOSAGE AND ADMINISTRATION, All Patients ). The active ingredient, cisplatin USP, is a yellow to orange crystalline powder. Cisplatin is a heavy metal complex containing a central atom of platinum surrounded by two chloride atoms and two ammonia molecules in the cis position. It is soluble in water or saline at 1 mg per mL and in dimethylformamide at 24 mg per mL. It has a melting point of 207°C. PtCl 2 H 6 N 2 M.W. 300.05 Chemical Structure

Clindamycin CLINDAMYCIN PHOSPHATE
SAGENT PHARMACEUTICALS FDA Rx Only

Clindamycin Injection, USP, a clear colorless to pale yellow sterile solution, contains clindamycin phosphate, a water soluble ester of clindamycin and phosphoric acid. Each mL contains the equivalent of 150 mg clindamycin, 0.5 mg disodium edetate and 9.45 mg benzyl alcohol added as preservative in each mL. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH. 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 ClN 2 O 8 PS and the molecular weight is 504.96. The structural formula is represented below: Structural Formula

Cyanocobalamin CYANOCOBALAMIN
1000 mcg/ml
SAGENT PHARMACEUTICALS FDA Rx Only

Cyanocobalamin Injection, USP is a sterile solution of cyanocobalamin for intramuscular or subcutaneous injection. Each mL contains 1,000 mcg cyanocobalamin. Each vial also contains Sodium Chloride, 0.9%. Benzyl Alcohol, 1.5%, is present as a preservative. Hydrochloric acid and/or sodium hydroxide may have been added during manufacture to adjust the pH (range 4.5 to 7.0). Cyanocobalamin appears as dark red crystals or as an amorphous or crystalline red powder. It is very hygroscopic in the anhydrous form, and sparingly soluble in water (1:80). It is stable to autoclaving for short periods at 121°C. The vitamin B 12 coenzymes are very unstable in light. The chemical name is 5,6-dimethyl-benzimidazolyl cyanocobamide; the molecular formula is C 63 H 88 CoN 14 O 14 P. The cobalt content is 4.34%. The molecular weight is 1355.39. The structural formula is represented below. Structural Formula

Cyclophosphamide CYCLOPHOSPHAMIDE
500 mg Injection
SAGENT PHARMACEUTICALS FDA Rx Only

Cyclophosphamide is an alkylating drug. It is an 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 has a molecular formula of 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 a sterile white cake available as 500 mg, 1 gram, and 2 gram strength single-dose vials. 500 mg vial contains 534.5 mg cyclophosphamide monohydrate equivalent to 500 mg cyclophosphamide and 375 mg mannitol 1 gram vial contains 1,069 mg cyclophosphamide monohydrate equivalent to 1 gram cyclophosphamide and 750 mg mannitol 2 gram vial contains 2,138 mg cyclophosphamide monohydrate equivalent to 2 grams cyclophosphamide and 1,500 mg mannitol Structural Formula

cytarabine CYTARABINE
20 mg/ml
SAGENT PHARMACEUTICALS FDA Rx Only

Cytarabine Injection, an antineoplastic, is a sterile solution of cytarabine for intravenous, intrathecal or subcutaneous administration. Each mL contains 20 mg Cytarabine (20 mg per mL) in a single dose vial (100 mg per 5 mL). Cytarabine Injection 100 mg per 5 mL is a sterile solution for intravenous, intrathecal or subcutaneous administration. Each mL contains 20 mg Cytarabine, USP, and the following inactive ingredients: sodium chloride 6.8 mg and Water for Injection q.s. When necessary the pH is adjusted with hydrochloric acid and/or sodium hydroxide to a pH of 7.4. Each vial contains approximately 0.58 mEq sodium. Cytarabine is chemically 1-β-D-Arabinofuranosylcytosine. The structural formula is: C 9 H 13 N 3 O 5 M.W. 243.22 Cytarabine is an odorless, white to off-white crystalline powder which is freely soluble in water and slightly soluble in alcohol and in chloroform. Structural Formula

cytarabine CYTARABINE
100 mg/ml
SAGENT PHARMACEUTICALS FDA Rx Only

Cytarabine Injection, an antineoplastic, is a sterile solution of cytarabine for intravenous, intrathecal or subcutaneous administration. Each mL contains 100 mg cytarabine USP, in 2 g per 20 mL (100 mg per mL) single dose vial and the following inactive ingredients: water for injection q.s. When necessary the pH is adjusted with hydrochloric acid and/or sodium hydroxide to a pH of 7.7. Cytarabine is chemically 1-β-D-Arabinofuranosylcytosine. The structural formula is: Cytarabine is an odorless, white to off-white crystalline powder which is freely soluble in water and slightly soluble in alcohol and in chloroform. Structural Formula

Daptomycin DAPTOMYCIN
350 mg Injection
SAGENT PHARMACEUTICALS FDA Rx Only

Daptomycin for Injection contains daptomycin, a cyclic lipopeptide antibacterial agent derived from the fermentation of Streptomyces roseosporus. The chemical name is N -decanoyl-L-tryptophyl-D-asparaginyl-L-aspartyl-L-threonylglycyl-L-ornithyl-L-aspartyl-D-alanyl-L-aspartylglycyl-D-seryl- threo -3-methyl-L-glutamyl-3-anthraniloyl-L-alanine ε 1 -lactone. The chemical structure is: The empirical formula is C 72 H 101 N 17 O 26 ; the molecular weight is 1620.67. Daptomycin for Injection is supplied in a single-dose vial as a sterile, preservative-free, pale yellow to light brown, lyophilized cake containing approximately 350 mg of daptomycin for intravenous (IV) use following reconstitution with 0.9% sodium chloride injection [see Dosage and Administration ( 2.7 )] . The only inactive ingredient is sodium hydroxide, which is used for pH adjustment; between 4.0 to 5.0. Freshly reconstituted solutions of Daptomycin for Injection range in color from pale yellow to light brown. Chemical Structure

Daptomycin DAPTOMYCIN
350 mg Injection
SAGENT PHARMACEUTICALS FDA Rx Only

Daptomycin for Injection contains daptomycin, a cyclic lipopeptide antibacterial agent derived from the fermentation of Streptomyces roseosporus. The chemical name is N -decanoyl-L-tryptophyl-D-asparaginyl-L-aspartyl-L-threonylglycyl-L-ornithyl-L-aspartyl-D-alanyl-L-aspartylglycyl-D-seryl- threo -3-methyl-L-glutamyl-3-anthraniloyl-L-alanine ε 1 -lactone. The chemical structure is: The empirical formula is C 72 H 101 N 17 O 26 ; the molecular weight is 1620.67. Daptomycin for Injection is supplied in a single-dose vial as a sterile, preservative-free, pale yellow to light brown, lyophilized cake containing approximately 350 mg of daptomycin for intravenous (IV) use following reconstitution with 0.9% sodium chloride injection [see Dosage and Administration ( 2.7 )] . The only inactive ingredient is sodium hydroxide, which is used for pH adjustment; between 4.0 to 5.0. Freshly reconstituted solutions of Daptomycin for Injection range in color from pale yellow to light brown. Chemical Structure

daptomycin DAPTOMYCIN
500 mg Injection
SAGENT PHARMACEUTICALS FDA Rx Only

Daptomycin for Injection contains daptomycin, a cyclic lipopeptide antibacterial agent derived from the fermentation of Streptomyces roseosporus. The chemical name is N -decanoyl-L-tryptophyl-D-asparaginyl-L-aspartyl-L-threonylglycyl-L-ornithyl-L-aspartyl-D-alanyl-L-aspartylglycyl-D-seryl- threo -3-methyl-L-glutamyl-3-anthraniloyl-L-alanine ε 1 -lactone. The chemical structure is: The empirical formula is C 72 H 101 N 17 O 26 ; the molecular weight is 1620.67. Daptomycin for Injection is supplied in a single-dose vial as a sterile, preservative-free, pale yellow to light brown, lyophilized cake containing approximately 500 mg of daptomycin for intravenous (IV) use following reconstitution with 0.9% sodium chloride injection [see Dosage and Administration ( 2.7 )] . The only inactive ingredient is sodium hydroxide, which is used for pH adjustment. Freshly reconstituted solutions of Daptomycin for Injection range in color from pale yellow to light brown. Chemical Structure

Decitabine DECITABINE
50 mg Injection
SAGENT PHARMACEUTICALS FDA Rx Only

Decitabine is a nucleoside metabolic inhibitor. Decitabine is a fine, white to almost white powder with the molecular formula of C 8 H 12 N 4 O 4 and a molecular weight of 228.21. Its chemical name is 4-amino-1-(2-deoxy-β-D-erythropentofuranosyl)-1,3,5-triazin-2(1 H )-one and it has the following structural formula: Decitabine is slightly soluble in ethanol/water (50/50), methanol/water (50/50) and methanol; sparingly soluble in water and soluble in dimethylsulfoxide (DMSO). Decitabine for Injection, for intravenous use, is a sterile, white to almost white lyophilized powder supplied in a clear colorless glass single-dose vial. Each 20 mL vial contains 50 mg decitabine, 68 mg monobasic potassium phosphate (potassium dihydrogen phosphate) and 11.6 mg sodium hydroxide. Sodium hydroxide and/or hydrochloric acid are used for pH adjustment. Structural Formula

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