hikma pharmaceuticals usa inc. - Medication Listings

Browse 381 medications manufactured by hikma pharmaceuticals usa inc.. Open a product record to review dosage forms, strengths, packaging, and related navigation.

Bumetanide BUMETANIDE
0.25 mg/ml
HIKMA PHARMACEUTICALS USA INC. FDA Rx Only

Bumetanide is a loop diuretic, available as 4 mL vials and 10 mL vials (0.25 mg/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 – 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

Bupivacaine Hydrochloride BUPIVACAINE HYDROCHLORIDE
HIKMA PHARMACEUTICALS USA INC. FDA Rx Only

Bupivacaine hydrochloride injection, USP contains bupivacaine hydrochloride, an amide local anesthetic, as the active pharmaceutical ingredient. The route of administration for Bupivacaine Hydrochloride injection is by injection, for infiltration, perineural, caudal, epidural, or retrobulbar use. Multiple-dose vials contain methylparaben [see Warnings and Precautions (5.4) ] . Bupivacaine hydrochloride is 2-piperidinecarboxamide, 1-butyl- N -(2,6-dimethylphenyl)-, monohydrochloride, monohydrate. It is a white crystalline powder that is freely soluble in 95 percent ethanol, soluble in water, and slightly soluble in chloroform or acetone. It has the following structural formula: Bupivacaine hydrochloride injection, USP is a clear and colorless sterile isotonic solution. Each mL contains 2.5 mg or 5 mg of bupivacaine hydrochloride (equivalent to 2.22 mg or 4.44 mg of bupivacaine, respectively), sodium chloride for isotonicity, sodium hydroxide or hydrochloric acid to adjust the pH between 4 and 6.5, in water for injection. For the Multiple-dose vials, each mL also contains 1 mg methylparaben as preservative. Bupivacaine Hydrochloride structure

Bupivacaine Hydrochloride BUPIVACAINE HYDROCHLORIDE
HIKMA PHARMACEUTICALS USA INC. FDA Rx Only

Bupivacaine hydrochloride injection, USP contains bupivacaine hydrochloride, an amide local anesthetic, as the active pharmaceutical ingredient. The route of administration for Bupivacaine Hydrochloride injection is by injection, for infiltration, perineural, caudal, epidural, or retrobulbar use. Bupivacaine hydrochloride is 2-piperidinecarboxamide, 1-butyl- N -(2,6-dimethylphenyl)-, monohydrochloride, monohydrate. It is a white crystalline powder that is freely soluble in 95 percent ethanol, soluble in water, and slightly soluble in chloroform or acetone. It has the following structural formula: Bupivacaine hydrochloride injection, USP is a clear and colorless sterile isotonic solution. Each mL of single-dose vial contains 2.5 mg, 5 mg or 7.5 mg of bupivacaine hydrochloride (equivalent to 2.22 mg, 4.44 mg or 6.66 mg of bupivacaine, respectively), sodium chloride for isotonicity, sodium hydroxide or hydrochloric acid to adjust the pH between 4 and 6.5, in water for injection. Bupivacaine Hydrochloride structure

Buprenorphine Hydrochloride BUPRENORPHINE HYDROCHLORIDE
HIKMA PHARMACEUTICALS USA INC. FDA Rx Only

Buprenorphine Hydrochloride Injection is a partial opioid agonist. The chemical name of buprenorphine hydrochloride is 21-(Cyclopropyl-7α-[( S )-1-hydroxy-1,2,2- trimethylpropyl]-6,14- endo -ethano-6,7,8,14-tetrahydrooripavine hydrochloride. Buprenorphine hydrochloride is a white powder, weakly acidic and with limited solubility in water. Buprenorphine HCl Injection is a clear, sterile, injectable agonist-antagonist analgesic intended for intravenous or intramuscular administration. Each mL of Buprenorphine HCl Injection contains 0.324 mg buprenorphine hydrochloride (equivalent to 0.3 mg buprenorphine), 50 mg anhydrous dextrose, water for injection and HCl to adjust pH. Buprenorphine hydrochloride has the molecular formula, C 29 H 41 NO 4 HCl, and the following structure: Molecular weight: 504.10 chemical structure

buprenorphine hydrochloride and naloxone hydrochloride dihydrate BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE
HIKMA PHARMACEUTICALS USA INC. FDA Rx Only

Buprenorphine and Naloxone Sublingual Tablets, USP are available in two dosage strengths intended for sublingual administration as follows: 2 mg buprenorphine with 0.5 mg naloxone free bases and 8 mg buprenorphine with 2 mg naloxone free bases. Each tablet also contains citric acid anhydrous, corn starch, FD & C yellow no. 6, lactose monohydrate, lemon-lime flavor, magnesium stearate, mannitol, povidone, sodium citrate dihydrate and sucralose. Chemically, buprenorphine HCl is (6R, 7R, 14S)-17-Cyclopropylmethyl-7,8-dihydro-7-[(1S)-1-hydroxy-1,2,2-trimethylpropyl]-6-O--methyl-6,14-ethano-17-normorphine hydrochloride. It has the following chemical structure: Buprenorphine hydrochloride, USP has the molecular formula C 29 H 41 NO 4 • HCl and the molecular weight is 504.1. It is a white to almost white crystalline powder, sparingly soluble in water, freely soluble in methanol, soluble in alcohol, and practically insoluble in cyclohexane. Chemically, naloxone HCl dihydrate, USP is 17-Allyl-4, 5 α-epoxy-3, 14-dihydroxymorphinan-6-one hydrochloride dihydrate. It has the following chemical structure: Naloxone hydrochloride dihydrate has the molecular formula C 19 H 22 ClNO 4, 2H 2 O and the molecular weight is 399.9. It is a white to slightly off-white powder or almost white crystalline powder and is freely soluble in water, soluble in alcohol, and practically insoluble in toluene and ether. buprenorphine-chem-structure.jpg naloxone-chem-structure.jpg

Butalbital, Acetaminophen, Caffeine and Codeine Phosphate BUTALBITAL ACETAMINOPHEN CAFFEINE AND CODEINE PHOSPHATE
HIKMA PHARMACEUTICALS USA INC. FDA Rx Only

Butalbital, Acetaminophen, Caffeine and Codeine Phosphate Capsules are supplied in two strength combinations in capsule form for oral administration. Butalbital, Acetaminophen, Caffeine and Codeine Phosphate Capsules, 50 mg/300 mg/40 mg/30 mg contain: Butalbital, USP……………………50 mg Acetaminophen, USP…………….300 mg Caffeine, USP……………………..40 mg Codeine Phosphate, USP………….30 mg Butalbital, Acetaminophen, Caffeine and Codeine Phosphate Capsules, 50 mg/325 mg/40 mg/30 mg contain: Butalbital, USP……………………50 mg Acetaminophen, USP…………….325 mg Caffeine, USP……………………..40 mg Codeine Phosphate, USP………….30 mg Butalbital, USP (5-allyl-5-isobutylbarbituric acid), is a short-to intermediate-acting barbiturate. It has the following structural formula: C 11 H 16 N 2 O 3 MW = 224.26 Acetaminophen, USP (4´-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula: C 8 H 9 NO 2 MW = 151.16 Caffeine, USP (1,3,7-trimethylxanthine), a methylxanthine, is a central nervous system stimulant. It has the following structural formula: C 8 H 10 N 4 O 2 MW = 194.19 Codeine Phosphate, USP (7,8-Didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1)(salt) hemihydrate) is an opioid agonist. It has the following structural formula: C 18 H 21 NO 3 •H 3 PO 4 •1/2H 2 O MW = 406.37 Inactive Ingredients : pregelatinized starch. colloidal silicon dioxide, magnesium stearate. The capsule cap is printed with white ink. The white ink contains shellac glaze, titanium dioxide, ammonium hydroxide, propylene glycol, and simethicone. The capsule body is printed with black ink. The black ink contains shellac glaze, iron oxide black, propylene glycol, and ammonium hydroxide. The capsule shell contains: gelatin, titanium dioxide for both strengths and FD&C red #40, FD&C blue #1 in the Butalbital, Acetaminophen, Caffeine and Codeine Phosphate Capsules, 50 mg/300 mg/40mg/30mg and FD&C red #3, FD&C blue #2, red iron oxide, yellow iron oxide in the Butalbital, Acetaminophen, Caffeine and Codeine Phosphate Capsules, 50 mg/325 mg/40mg/30mg. image-butalbital-usp-chem-structure image-acetaminophen-usp-chem-structure image-caffeine-usp-chem-structure codeine-phosphate-structural-formula

Butorphanol Tartrate BUTORPHANOL TARTRATE
HIKMA PHARMACEUTICALS USA INC. FDA Rx Only

Butorphanol tartrate is an opioid agonist-antagonist of the phenanthrene series. The chemical name is (-)-17-(cyclobutylmethyl) morphinan-3,14-diol [S-(R*,R*)]-2,3-dihydroxybutanedioate(1:1)(salt). The molecular formula is C 21 H 29 NO 2 ,C 4 H 6 O 6 , which corresponds to a molecular weight of 477.55 and the following structural formula: Butorphanol tartrate is a white crystalline substance. The dose is expressed as the tartrate salt. One milligram of the salt is equivalent to 0.68 mg of the free base. The n-octanol/aqueous buffer partition coefficient of butorphanol is 180:1 at pH 7.5. Butorphanol Tartrate Injection, USP is a sterile, nonpyrogenic, parenteral, aqueous solution of butorphanol tartrate for intravenous or intramuscular administration. Each milliliter (mL) of solution contains, butorphanol tartrate 1 or 2 mg, 3.3 mg of citric acid, 6.4 mg sodium citrate, and 6.4 mg sodium chloride, and 0.1 mg benzethonium chloride (in multiple dose vial only) as a preservative. Structural Formula

Butorphanol Tartrate BUTORPHANOL TARTRATE
HIKMA PHARMACEUTICALS USA INC. FDA Rx Only

Butorphanol tartrate is a synthetically derived opioid agonist-antagonist analgesic of the phenanthrene series. The chemical name is (-)-17-(cyclobutylmethyl)morphinan-3,14-diol [S-(R*,R*)]-2,3-dihydroxybutanedioate (1:1) (salt). The molecular formula is C 21 H 29 NO 2 •C 4 H 6 O 6 , which corresponds to a molecular weight of 477.55 g/mol and the following structural formula: Butorphanol tartrate, USP is a white crystalline substance. The dose is expressed as the tartrate salt. One milligram of the salt is equivalent to 0.68 mg of the free base. The n-octanol/aqueous buffer partition coefficient of butorphanol is 180:1 at pH 7.5. Butorphanol Tartrate Nasal Spray, USP is an aqueous solution of butorphanol tartrate for administration as a metered spray to the nasal mucosa. Each bottle of Butorphanol Tartrate Nasal Spray, USP contains 2.5 mL of a 10 mg/mL solution of butorphanol tartrate with sodium chloride, citric acid, and benzethonium chloride in purified water with sodium hydroxide and/or hydrochloric acid added to adjust the pH to 5.0. The pump reservoir must be fully primed [see PATIENT INSTRUCTIONS ] prior to initial use. After initial priming each metered spray delivers an average of 1.0 mg of butorphanol tartrate and the 2.5 mL bottle will deliver an average of 14 to 15 doses of Butorphanol Tartrate Nasal Spray, USP. If not used for 48 hours or longer, the unit must be reprimed [see PATIENT INSTRUCTIONS ]. With intermittent use requiring repriming before each dose, the 2.5 mL bottle will deliver an average of 8 to 10 doses of Butorphanol Tartrate Nasal Spray, USP depending on how much repriming is necessary. chem.jpg

CAFCIT CAFFEINE CITRATE
HIKMA PHARMACEUTICALS USA INC. FDA Rx Only

CAFCIT® Injection (caffeine citrate injection, USP) for intravenous administration is a clear, colorless, sterile, non-pyrogenic, preservative-free, aqueous solution 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

Caffeine Citrate CAFFEINE CITRATE
HIKMA PHARMACEUTICALS USA INC. FDA Rx Only

Caffeine Citrate Injection, USP for intravenous administration is a clear, colorless, sterile, non-pyrogenic, preservative-free, aqueous solution 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
HIKMA PHARMACEUTICALS USA INC. 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, 5.0 mg; sodium acetate trihydrate, USP, 2.0 mg; sodium chloride, USP, 7.5 mg; water for injection, USP. The activity of calcitonin salmon injection 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. Chemical Structure

Calcitriol CALCITRIOL
1 mcg/ml
HIKMA PHARMACEUTICALS USA INC. FDA Rx Only

Calcitriol Oral Solution is a synthetic vitamin D analog which is active in the regulation of the absorption of calcium from the gastrointestinal tract and its utilization in the body. Calcitriol Oral Solution is available as an oral solution, for oral administration, containing 1 mcg/mL of calcitriol, USP. Calcitriol Oral Solution contains butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT), and medium chain triglycerides. Calcitriol, USP is a white to almost white crystal which occurs naturally in humans. It has a calculated molecular weight of 416.6 and is soluble in organic solvents but practically insoluble in water. Chemically, calcitriol, USP is 9,10-seco(5Z,7E)-5,7,10(19)-cholestatriene-1α, 3β, 25-triol and has the following structural formula: C 27 H 44 O 3 The other names frequently used for calcitriol, USP are 1α,25-dihydroxycholecalciferol, 1,25-dihydroxyvitamin D 3 , 1,25-DHCC, 1,25(OH) 2 D 3 and 1,25-diOHC. chem-structure.jpg

Calcitriol CALCITRIOL
0.25 mcg
HIKMA PHARMACEUTICALS USA INC. FDA Rx Only

Calcitriol is a synthetic vitamin D analog which is active in the regulation of the absorption of calcium from the gastrointestinal tract and its utilization in the body. Calcitriol capsules are available containing 0.25 mcg of calcitriol, USP. Calcitriol capsules contain butylated hydroxyanisole (BHA) and butylated hydroxytoluene (BHT) as antioxidants. The capsules contain a fractionated triglyceride of coconut oil. Gelatin capsule shells contain gelatin, glycerin (anhydrous), and titanium dioxide, with the following dyes: FD&C Yellow No. 5 and FD&C Yellow No. 6. In addition to the ingredients listed above, each capsule contains Opacode (Black) monogramming ink. Opacode (Black) contains ammonium hydroxide, iron oxide black, isopropyl alcohol, macrogol, polyvinyl acetate phthalate, propylene glycol, purified water and SDA 35A alcohol. Calcitriol, USP is a white to almost white crystal which occurs naturally in humans. It has a calculated molecular weight of 416.6 and is soluble in organic solvents but practically insoluble in water. Chemically, calcitriol, USP is 9,10-seco(5Z,7E)-5,7,10(19)-cholestatriene-1α, 3β, 25-triol and has the following structural formula: C 27 H 44 O 3 The other names frequently used for calcitriol, USP are 1α, 25-dihydroxycholecalciferol, 1,25-dihydroxyvitamin D 3 ,1,25-DHCC, 1,25(OH) 2 D 3 and 1,25-diOHC. chem-structure.jpg

Calcium Acetate CALCIUM ACETATE
667 mg Capsule
HIKMA PHARMACEUTICALS USA INC. FDA Rx Only

Calcium acetate acts as a phosphate binder. Its chemical name is calcium acetate. Its molecular formula is C 4 H 6 CaO 4 , and its molecular weight is 158.17. Its structural formula is: Each white opaque/blue opaque capsule contains 667 mg of calcium acetate, USP (anhydrous; Ca(CH 3 COO) 2 ; MW=158.17 grams) equal to 169 mg (8.45 mEq) calcium, polyethylene glycol 8000 and magnesium stearate. Each capsule shell contains: black monogramming ink, FD&C Blue #1, FD&C Red #3, gelatin and titanium dioxide. The black monogramming ink contains: ammonium hydroxide, iron oxide black, isopropyl alcohol, n-butyl alcohol, propylene glycol and shellac glaze. Calcium Acetate Capsules, USP are administered orally for the control of hyperphosphatemia in end-stage renal failure. chem.jpg

calcium gluconate CALCIUM GLUCONATE
10000 mg/100 ml Injection
HIKMA PHARMACEUTICALS USA INC. FDA Rx Only

Calcium Gluconate Injection, USP is a clear, colorless to slightly yellow, sterile, preservative-free, nonpyrogenic, supersaturated solution of calcium gluconate, a form of calcium, for intravenous use. Calcium Gluconate is calcium D-gluconate (1:2) monohydrate. The structural formula is: Molecular formula: C 12 H 22 CaO 14 • H 2 O Molecular weight: 448.39 Solubility in water: 3.5 g/100 mL at 25°C Calcium Gluconate Injection, USP is available as 10,000 mg per 100 mL (100 mg per mL) in a pharmacy bulk package. Each mL of Calcium Gluconate Injection, USP contains 100 mg of calcium gluconate (equivalent to 94 mg of calcium gluconate and 4.5 mg of calcium saccharate tetrahydrate), hydrochloric acid and/or sodium hydroxide for pH adjustment (6.0 to 8.2) and water for injection, q.s. It contains no antimicrobial agent. Each mL of Calcium Gluconate Injection, USP contains 9.3 mg (0.465 mEq) of elemental calcium. structure.jpg

calcium gluconate CALCIUM GLUCONATE
5000 mg/50 ml Injection
HIKMA PHARMACEUTICALS USA INC. FDA Rx Only

Calcium Gluconate Injection, USP is a clear, colorless to slightly yellow, sterile, preservative-free, nonpyrogenic, supersaturated solution of calcium gluconate, a form of calcium, for intravenous use. Calcium Gluconate is calcium D-gluconate (1:2) monohydrate. The structural formula is: Molecular formula: C 12 H 22 CaO 14 • H 2 O Molecular weight: 448.39 Solubility in water: 3.5 g/100 mL at 25°C Calcium Gluconate Injection, USP is available as 5,000 mg per 50 mL (100 mg per mL) in a single-dose vial. Each mL of Calcium Gluconate Injection, USP contains 100 mg of calcium gluconate (equivalent to 94 mg of calcium gluconate and 4.5 mg of calcium saccharate tetrahydrate), hydrochloric acid and/or sodium hydroxide for pH adjustment (6.0 to 8.2) and water for injection, q.s. It contains no antimicrobial agent. Each mL of Calcium Gluconate Injection, USP contains 9.3 mg (0.465 mEq) of elemental calcium. structure.jpg

calcium gluconate CALCIUM GLUCONATE
1000 mg/10 ml Injection
HIKMA PHARMACEUTICALS USA INC. FDA Rx Only

Calcium Gluconate Injection, USP is a clear, colorless to slightly yellow, sterile, preservative-free, nonpyrogenic, supersaturated solution of calcium gluconate, a form of calcium, for intravenous use. Calcium Gluconate is calcium D-gluconate (1:2) monohydrate. The structural formula is: Molecular formula: C 12 H 22 CaO 14 • H 2 O Molecular weight: 448.39 Solubility in water: 3.5 g/100 mL at 25°C Calcium Gluconate Injection, USP is available as 1,000 mg per 10 mL (100 mg per mL) in a single-dose vial. Each mL of Calcium Gluconate Injection, USP contains 100 mg of calcium gluconate (equivalent to 94 mg of calcium gluconate and 4.5 mg of calcium saccharate tetrahydrate), hydrochloric acid and/or sodium hydroxide for pH adjustment (6.0 to 8.2) and water for injection, q.s. It contains no antimicrobial agent. Each mL of Calcium Gluconate Injection, USP contains 9.3 mg (0.465 mEq) of elemental calcium. structure.jpg

Captopril CAPTOPRIL
12.5 mg
HIKMA PHARMACEUTICALS USA INC. FDA Rx Only

Captopril Tablets, USP are a specific competitive inhibitor of angiotensin I-converting enzyme (ACE), the enzyme responsible for the conversion of angiotensin I to angiotensin II. Captopril is designated chemically as 1-[(2S)-3-mercapto-2-methylpropionyl]-L-proline and has the following structural formula: MW 217.29 Captopril is a white to off-white crystalline powder that may have a slight sulfurous odor; it is soluble in water (approx. 160 mg/mL), methanol, and ethanol and sparingly soluble in chloroform and ethyl acetate. Each tablet for oral administration contains 12.5 mg, 25 mg, 50 mg or 100 mg of captopril. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, microcrystalline cellulose, sodium starch glycolate (derived from potato), starch (derived from corn), and stearic acid. Structural Formula

Cefazolin CEFAZOLIN
HIKMA PHARMACEUTICALS USA 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)acetoamido]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid. The structural formula is as follows: Cefazolin for Injection, USP is a white to cream sterile powder. The color of Cefazolin for Injection, USP solutions may range from pale yellow to yellow without a change in potency. The pH ranges from 4.0 and 6.0 for a solution containing 100 mg of cefazolin per mL. Cefazolin for Injection, USP is supplied in 10 or 20 grams Pharmacy Bulk Packages. Each Pharmacy Bulk Package contains Cefazolin Sodium, USP equivalent to 10 or 20 grams of cefazolin. The sodium content is approximately 48 mg (2.1 mEq) per gram of cefazolin sodium. It is to be administered by intravenous route. A Pharmacy Bulk Package is a container of a sterile preparation for intravenous 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 . Cef Chemical Structure

Cefazolin CEFAZOLIN
HIKMA PHARMACEUTICALS USA INC. 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. The molecular formula is C 14 H 13 N 8 NaO 4 S 3 and molecular weight is 476.49. Structural Formula: Each vial contains 48 mg of sodium/1 gram of cefazolin sodium. Cefazolin for Injection, USP is white to off-white crystalline powder, supplied in vials equivalent to 500 mg or 1 gram of cefazolin. Chemical structure

Cefazolin CEFAZOLIN
HIKMA PHARMACEUTICALS USA 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)acetoamido]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid. The structural formula is as follows: Cefazolin for Injection, USP is a white to cream sterile powder. The color of Cefazolin for Injection, USP solutions may range from pale yellow to yellow without a change in potency. The pH ranges from 4.0 and 6.0 for a solution containing 100 mg of cefazolin per mL. Cefazolin for Injection, USP is supplied in 10 or 20 grams Pharmacy Bulk Packages. Each Pharmacy Bulk Package contains Cefazolin Sodium, USP equivalent to 10 or 20 grams of cefazolin. The sodium content is approximately 48 mg (2.1 mEq) per gram of cefazolin sodium. It is to be administered by intravenous route. A Pharmacy Bulk Package is a container of a sterile preparation for intravenous 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 . Cef Chemical Structure

Cefazolin CEFAZOLIN
HIKMA PHARMACEUTICALS USA INC. 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. The molecular formula is C 14 H 13 N 8 NaO 4 S 3 and molecular weight is 476.49. Structural Formula: Each vial contains 48 mg of sodium/1 gram of cefazolin sodium. Cefazolin for Injection, USP is white to off-white crystalline powder, supplied in vials equivalent to 500 mg or 1 gram of cefazolin. Chemical structure

Cefazolin CEFAZOLIN
2 g Injection
HIKMA PHARMACEUTICALS USA INC. FDA Rx Only

Cefazolin for Injection contains cefazolin sodium, a semi-synthetic cephalosporin. 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. The molecular formula is C 14 H 13 N 8 NaO 4 S 3 and molecular weight is 476.49. Structural Formula: Structural Formula Cefazolin for Injection is supplied as a sterile powder in single-dose vials. The 2 g/vial Cefazolin for Injection contains 2 grams of cefazolin (equivalent to 2.097 g of cefazolin sodium). The 3 g/vial Cefazolin for Injection contains 3 grams of cefazolin (equivalent to 3.144 grams of cefazolin sodium). The 2 g/vial Cefazolin for Injection contains 96 mg of sodium. The 3 g/vial Cefazolin for Injection contains 144 mg of sodium. After reconstitution with sterile water for injection, the drug product solution has a pH of 4.0 to 6.0. Cefazolin for Injection, 2 grams/vial, is intended for intravenous infusion or intravenous bolus injection. Cefazolin for Injection, 2 grams/vial is not for intramuscular administration. Cefazolin for Injection, 3 grams/vial, is intended for intravenous infusion only. Cefazolin for Injection, 3 grams/vial is not for intravenous bolus injection or intramuscular administration in adult or pediatric patients [see Dosage and Administration (2.1 , 2.2 , 2.3 )] . Structural Formula

Cefepime Hydrochloride CEFEPIME HYDROCHLORIDE
HIKMA PHARMACEUTICALS USA INC. FDA Rx Only

Cefepime for Injection, USP (cefepime hydrochloride, 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,72-(Z)-(O-methyloxime), monohydrochloride, monohydrate, which corresponds to the following structural formula: 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 g and 2 g 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 725 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

Cefotaxime CEFOTAXIME
HIKMA PHARMACEUTICALS USA INC. FDA Rx Only

Sterile cefotaxime sodium is a semisynthetic, broad spectrum cephalosporin antibiotic for parenteral administration. It is the sodium salt of 7-[2-(2-amino-4-thiazolyl) glyoxylamido]-3(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo [4.2.0] oct-2-ene-2-carboxylate 72 (Z)-(o-methyloxime), acetate (ester). Cefotaxime for Injection, USP contains approximately 50.5 mg (2.2 mEq) of sodium per gram of cefotaxime activity. Solutions of Cefotaxime for Injection, USP range from very pale yellow to light amber depending on the concentration and the diluent used. The pH of the injectable solutions usually ranges from 5.0 to 7.5. The CAS Registry Number is 64485-93-4. C 16 H 16 N 5 NaO 7 S 2 MW 477.45 Cefotaxime for Injection, USP is supplied as a dry powder in vials. Each vial contains cefotaxime sodium, equivalent to 500 mg, 1 gram or 2 grams of cefotaxime. Structural Formula

Cefotaxime CEFOTAXIME
HIKMA PHARMACEUTICALS USA INC. FDA Rx Only

Sterile cefotaxime sodium is a semisynthetic, broad spectrum cephalosporin antibiotic for parenteral administration. It is the sodium salt of 7-[2-(2-amino-4-thiazolyl) glyoxylamido]-3-(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo [4.2.0] oct-2-ene-2-carboxylate 72 (Z)-(o-methyloxime), acetate (ester). Cefotaxime for Injection, USP contains approximately 50.5 mg (2.2 mEq) of sodium per gram of cefotaxime activity. Solutions of Cefotaxime for Injection, USP range from very pale yellow to light amber depending on the concentration and the diluent used. The pH of the injectable solutions usually ranges from 5.0 to 7.5. The CAS Registry Number is 64485-93-4. C 16 H 16 N 5 NaO 7 S 2 MW 477.45 Cefotaxime for Injection, USP is supplied as a dry powder in Pharmacy Bulk Packages containing cefotaxime sodium equivalent to 10 g of cefotaxime. FURTHER DILUTION IS REQUIRED BEFORE USE. A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use, which contains many single doses. This Pharmacy Bulk Package is for use in a pharmacy admixture service; it provides many singles doses of cefotaxime for addition to suitable parenteral fluids in the preparation of admixtures for intravenous infusion. (See DOSAGE AND ADMINISTRATION and DIRECTIONS FOR PROPER USE OF PHARMACY BULK PACKAGE .) Chemical structure

Cefotetan CEFOTETAN
HIKMA PHARMACEUTICALS USA INC. FDA Rx Only

Cefotetan for Injection, USP, as cefotetan disodium, is a sterile, semisynthetic, broad-spectrum, beta-lactamase resistant, cephalosporin (cephamycin) antibiotic for parenteral administration. It is the disodium salt of [6R-(6α,7α)]-7-[[[4-(2-amino-1-carboxy-2-oxoethylidene)-1,3-dithietan-2-yl]carbonyl]amino]-7-methoxy-3-[[(1-methyl-1H-tetrazol-5-yl)thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid. Structural formula: Cefotetan for Injection, USP is supplied in vials containing 80 mg (3.5 mEq) of sodium per gram of cefotetan activity. It is a white to pale yellow powder which is very soluble in water. Reconstituted solutions of Cefotetan for Injection, USP are intended for intravenous and intramuscular administration. The solution varies from colorless to yellow depending on the concentration. The pH of freshly reconstituted solutions is usually between 4.5 to 6.5. Cefotetan for Injection, USP is available in two vial strengths. Each 1 gram vial contains cefotetan disodium equivalent to 1 gram cefotetan activity. Each 2 gram vial contains cefotetan disodium equivalent to 2 grams cefotetan activity. STRUCTURE

Cefoxitin CEFOXITIN
HIKMA PHARMACEUTICALS USA INC. FDA Rx Only

Cefoxitin for Injection, USP is a semi-synthetic, broad-spectrum cepha antibiotic sealed under nitrogen for intravenous administration. It is derived from cephamycin C, which is produced by Streptomyces lactamdurans. Its chemical name is sodium (6R,7S)-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 N a O 7 S 2 , and the structural formula is: Cefoxitin for injection 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 Pharmacy Bulk Package Bottle of Cefoxitin for Injection, USP contains sterile cefoxitin sodium, USP equivalent to 10 grams of cefoxitin. This Pharmacy Bulk Package Bottle is a container of sterile preparation for intravenous 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. AFTER RECONSTITUTION FURTHER DILUTION IS REQUIRED BEFORE USE. NOT FOR DIRECT INFUSION. chemical structure

Cefoxitin CEFOXITIN
HIKMA PHARMACEUTICALS USA INC. FDA Rx Only

Cefoxitin for injection is a semi-synthetic, broad-spectrum cepha antibiotic sealed under nitrogen for intravenous administration. It is derived from cephamycin C, which is produced by Streptomyces lactamdurans. Its chemical name is sodium (6R,7S)-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 contains approximately 53.8 mg (2.3 milliequivalents) of sodium per gram of cefoxitin activity. Solutions of cefoxitin for injection range from colorless to light amber in color. The pH of freshly constituted solutions usually ranges from 4.2 to 7.0. Cefoxitin for Injection, USP contains sterile cefoxitin sodium, USP equivalent to 1 or 2 grams cefoxitin. Chemical structure

Ceftriaxone CEFTRIAXONE
HIKMA PHARMACEUTICALS USA 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 1 8 H 1 6 N 8 Na 2 O 7 S 3 •3.5H 2 O. It has a calculated molecular weight of 661.59 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

Ceftriaxone CEFTRIAXONE
HIKMA PHARMACEUTICALS USA 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-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 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

Cefuroxime CEFUROXIME
HIKMA PHARMACEUTICALS USA INC. FDA Rx Only

Cefuroxime, USP is a sterile semisynthetic, broad-spectrum, cephalosporin antibiotic for parenteral administration. It is the sodium salt of (6R,7R)-3-carbamoyloxymethyl-7-[Z-2-methoxyimino-2-(fur-2-yl)acetamido]ceph-3-em-4-carboxylate, and it has the following structural formula: The molecular formula is C 16 H 15 N 4 NaO 8 S, representing a molecular weight of 446.4. 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 as Pharmacy Bulk Package equivalent to 7.5 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. 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. cefuroxime chemical structure

Cefuroxime CEFUROXIME
HIKMA PHARMACEUTICALS USA INC. FDA Rx Only

Cefuroxime, USP is a sterile semisynthetic, broad-spectrum, cephalosporin antibiotic for parenteral administration. It is the sodium salt of (6R,7R)-3-carbamoyloxymethyl-7-[Z-2-methoxyimino-2-(fur-2-yl)acetamido]ceph-3-em-4-carboxylate, and it has the following structural formula: The molecular formula is C 16 H 15 N 4 NaO 8 S, representing a molecular weight of 446.4. 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. cefuroxime chemical structure

Cefuroxime CEFUROXIME
HIKMA PHARMACEUTICALS USA INC. FDA Rx Only

Cefuroxime, USP is a sterile semisynthetic, broad-spectrum, cephalosporin antibiotic for parenteral administration. It is the sodium salt of (6R,7R)-3-carbamoyloxymethyl-7-[Z-2-methoxyimino-2-(fur-2-yl)acetamido]ceph-3-em-4-carboxylate, and it has the following structural formula: The molecular formula is C 16 H 15 N 4 NaO 8 S, representing a molecular weight of 446.4. 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 as Pharmacy Bulk Package equivalent to 7.5 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. 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. chemical structure

Cefuroxime CEFUROXIME
HIKMA PHARMACEUTICALS USA INC. FDA Rx Only

Cefuroxime is a sterile semisynthetic, broad-spectrum, cephalosporin antibiotic for parenteral administration. It is the sodium salt of (6R,7R)-3-carbamoyloxymethyl-7-[Z-2-methoxyimino-2-(fur-2-yl)acetamido]ceph-3-em-4-carboxylate, and it has the following structural formula: The molecular formula is C 16 H 15 N 4 NaO 8 S, representing a molecular weight of 446.4. 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. cefuroxime chemical structure

Cevimeline Hydrochloride CEVIMELINE HYDROCHLORIDE
HIKMA PHARMACEUTICALS USA INC. FDA Rx Only

Cevimeline hydrochloride is Spiro[1-azabicyclo[2.2.2]octane-3,5′-[1,3]oxathiolane], 2′-methyl-,hydrochloride, hydrate (2:1), cis- . Its molecular formula is C 10 H 17 NOS∙HCl∙1/2 H 2 O, and its structural formula is: Cevimeline hydrochloride, USP has a molecular weight of 244.78. It is a white to off white crystalline powder with a melting point range of 201 to 203°C. It is freely soluble in alcohol and chloroform, very soluble in water, and virtually insoluble in ether. The pH of a 1% solution ranges from 4.6 to 5.6. Inactive ingredients include hydroxypropyl cellulose, lactose monohydrate, and magnesium stearate. Gelatin capsule shells contain: gelatin, monogramming ink, purified water, sodium lauryl sulfate and titanium dioxide. The monogramming ink contains: ammonium hydroxide, iron oxide, isopropyl alcohol, n-butyl alcohol, propylene glycol and shellac. Chemical Stucture

Chloroprocaine Hydrochloride CHLOROPROCAINE HYDROCHLORIDE
HIKMA PHARMACEUTICALS USA INC. FDA Rx Only

Chloroprocaine Hydrochloride Injection, USP is a sterile non-pyrogenic local anesthetic. The active ingredient is chloroprocaine HCl (benzoic acid, 4-amino-2-chloro-2-(diethylamino) ethyl ester, monohydrochloride), which is represented by the following structural formula: Molecular Formula: C 13 H 19 ClN 2 O 2 • HCl M. W. 307.22 Chloroprocaine Hydrochloride Injection, USP is available in a 2% and 3% solution for infiltration, nerve block, caudal and epidural anesthesia ( not for spinal anesthesia). Each mL of the 20 mg/mL, 2%, solution contains; 20 mg of Chloroprocaine HCl, USP, 4.7 mg of Sodium Chloride, USP, and Sodium Hydroxide and/or Hydrochloric Acid to adjust pH. The pH range is 2.7 to 4.0. Each mL of the 30 mg/mL, 3%, solution contains; 30 mg of Chloroprocaine HCl, USP, 3.3 mg of Sodium Chloride, USP, and Sodium Hydroxide and/or Hydrochloric Acid to adjust pH. The pH range is 2.7 to 4.0. Chloroprocaine HCl Injection, USP, should not be resterilized by autoclaving. structural formula

Chlorpromazine hydrochloride CHLORPROMAZINE HYDROCHLORIDE
HIKMA PHARMACEUTICALS USA INC. FDA Rx Only

Chlorpromazine HCl is chemically designated as 2-Chloro-10-[3-(dimethylamino)propyl]-phenothiazine monohydrochloride and has the following structural formula: C 17 H 19 ClN 2 S • HCl MW 355.33 Chlorpromazine Hydrochloride Injection, USP is a sterile aqueous solution intended for deep intramuscular use. Each mL contains chlorpromazine hydrochloride 25 mg, ascorbic acid 2 mg, sodium metabisulfite 1 mg, sodium sulfite 1 mg and sodium chloride 6 mg in Water for Injection. pH is 3.4-5.4. Chlorpromazine Hydrochloride Injection structural formula

Cisatracurium Besylate CISATRACURIUM BESYLATE
20 mg Injection
HIKMA PHARMACEUTICALS USA INC. FDA Rx Only

Cisatracurium Besylate Injection, USP 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 1243.49. The structural formula of cisatracurium besylate is: Cisatracurium Besylate Structural Formula 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, USP is between 3.0 and 3.8. Cisatracurium Besylate Structural Formula

Cisatracurium Besylate CISATRACURIUM BESYLATE
10 mg Injection
HIKMA PHARMACEUTICALS USA INC. FDA Rx Only

Cisatracurium Besylate Injection, USP 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 1243.49. The structural formula of cisatracurium besylate is: Cisatracurium Besylate structural formula 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, USP is between 3.0 and 3.8. Cisatracurium Besylate structural formula

CISplatin CISPLATIN
1 mg/ml
HIKMA PHARMACEUTICALS USA INC. FDA Rx Only

Cisplatin Injection infusion concentrate is a clear, colorless, sterile aqueous solution. Each 50 mL or 100 mL amber vial of Cisplatin Injection contains: 1 mg/mL cisplatin, 9 mg/mL sodium chloride, hydrochloric acid and/or sodium hydroxide to adjust pH, and water for injection to a final volume of 50 mL or 100 mL, respectively. The pH range of Cisplatin Injection is 3.8 to 5.9. Cisplatin Injection infusion concentrate must be further diluted prior to administration (see DOSAGE AND ADMINISTRATION, All Patients ). The active ingredient, cisplatin, is a yellow to orange crystalline powder with the molecular formula PtCl 2 H 6 N 2 , and a molecular weight of 300.1. 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/mL and in dimethylformamide at 24 mg/mL. It has a melting point of 207°C. chemical structure

Cladribine CLADRIBINE
HIKMA PHARMACEUTICALS USA INC. FDA Rx Only

Cladribine Injection, USP (also commonly known as 2-chloro-2´-deoxy-ß-D-adenosine) is a synthetic antineoplastic agent for continuous intravenous infusion. It is a clear, colorless, sterile, preservative-free, isotonic solution. Cladribine Injection, USP is available in single-use vials containing 10 mg (1 mg/mL) of cladribine, a chlorinated purine nucleoside analog. Each mL of cladribine injection, USP contains 1 mg of the active ingredient and 9 mg (0.15 mEq) of sodium chloride as an inactive ingredient. The solution has a pH range of 5.5 to 8.0. Phosphoric acid and/or dibasic sodium phosphate may have been added to adjust the pH to 6.3 ± 0.3. The chemical name for cladribine is 2-chloro-6-amino-9-(2-deoxy-ß-D- erythro -pentofuranosyl)purine and the structure is represented below: Molecular Formula = C 10 H 12 ClN 5 O 3 Molecular Weight = 285.69 structure

Clindamycin in 5 percent Dextrose CLINDAMYCIN IN PERCENT DEXTROSE
HIKMA PHARMACEUTICALS USA INC. FDA Rx Only

Clindamycin in 5% Dextrose Injection in vials contains 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 504.96. The structural formula is represented below: Structural Formula

Clonidine Hydrochloride CLONIDINE HYDROCHLORIDE
HIKMA PHARMACEUTICALS USA INC. FDA Rx Only

Clonidine Hydrochloride Injection, USP is a centrally-acting analgesic solution for use in continuous epidural infusion devices. Clonidine Hydrochloride, USP, is an imidazoline derivative and exists as a mesomeric compound. The chemical names are Benzenamine, 2, 6-dichloro-N-2-imidazolidinylidene monohydrochloride and 2-[(2,6-dichlorophenyl) imino]imidazolidine monohydrochloride. The following is the structural formula: Clonidine Hydrochloride Injection, USP is supplied as a clear, colorless, preservative-free, pyrogen-free, aqueous sterile solution (pH 5 to 7) in 10 mL single-dose vials. Each mL of the 1000 mcg/10 mL (0.1 mg/mL) concentration contains 100 mcg of Clonidine Hydrochloride, USP and 9 mg Sodium Chloride, USP in Water for Injection, USP. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment. Each 10 mL vial contains 1 mg (1000 mcg) of clonidine hydrochloride. Each mL of the 5000 mcg/10 mL (0.5 mg/mL) concentration contains 500 mcg of Clonidine Hydrochloride, USP and 9 mg Sodium Chloride, USP in Water for Injection, USP. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment. Each 10 mL vial contains 5 mg (5000 mcg) of clonidine hydrochloride. Clonidine hydrochloride structural formula

Codeine sulfate CODEINE SULFATE
15 mg Tablet
HIKMA PHARMACEUTICALS USA INC. FDA Rx Only

Codeine Sulfate Tablets, USP contain codeine, an opioid agonist, available for oral administration containing either 15 mg, 30 mg, or 60 mg of codeine sulfate, USP. The chemical name is morphinan-6-ol,7,8-didehydro-4,5-epoxy-3-methoxy-17-methyl-(5α,6α)-, sulfate (2:1) (salt), trihydrate. Its molecular formula is (C 18 H 21 NO 3 ) 2 • H 2 SO 4 • 3H 2 O and its molecular weight is 750.85 g/mol. Its structure is as follows: Codeine sulfate trihydrate is a fine, white, crystalline powder which is soluble in water and insoluble in chloroform and ether. The inactive ingredients in Codeine Sulfate Tablets, USP include: colloidal silicon dioxide, microcrystalline cellulose, pregelatinized starch and stearic acid. Chemical Structure

Colchicine COLCHICINE
0.6 mg Capsule
HIKMA PHARMACEUTICALS USA INC. FDA Rx Only

Colchicine is an alkaloid obtained from the plant colchicum autumnale . The chemical name for colchicine is ( S)-N- (5,6,7,9- tetrahydro-1,2,3,10-tetramethoxy-9 oxobenzol[a]heptalen-7-yl) acetamide. The structural formula is represented below: Colchicine consists of pale yellow scales or powder; it darkens on exposure to light. Colchicine is soluble in water, freely soluble in alcohol, and slightly soluble in ether. Colchicine capsules are supplied for oral administration. Each capsule contains 0.6 mg colchicine, USP and the following inactive ingredients: colloidal silicon dioxide, lactose anhydrous, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The capsule shell contains gelatin, purified water, titanium dioxide, erythrosine, Brilliant Blue FCF, and may contain D&C Red No. 28, FD&C Red No. 40 and Quinoline Yellow. Structural Formula Image

Combogesic ACETAMINOPHEN AND IBUPROFEN
HIKMA PHARMACEUTICALS USA INC FDA Rx Only

COMBOGESIC tablets are a combination of acetaminophen, an analgesic and antipyretic, and ibuprofen, a non-steroidal anti-inflammatory drug (NSAID). The chemical name for acetaminophen is N -acetyl- p -aminophenol. The molecular formula is C 8 H 9 NO 2 and the structural formula is: The molecular weight of acetaminophen is 151.17. Acetaminophen is a white, odorless, crystalline powder, possessing a slightly bitter taste. Acetaminophen is soluble in boiling water and 1N sodium hydroxide, and is freely soluble in alcohol. The chemical name for ibuprofen is (±)-2-(p-isobutylphenyl) propionic acid. The molecular formula is C 13 H 18 O 2 and the structural formula is: The molecular weight of ibuprofen is 206.29. Ibuprofen is a white powder with a melting point of 74-77°C and is very slightly soluble in water (<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. COMBOGESIC tablets contain 325 mg acetaminophen and 97.5 mg ibuprofen and are white in color. The inactive ingredients in the tablet are croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, maltodextrin, medium chain triglycerides, microcrystalline cellulose, polydextrose, povidone-30, sodium lauryl sulfate, talc, titanium dioxide. Chemical Structure Chemical Structure

COMBOGESIC IV ACETAMINOPHEN AND IBUPROFEN
HIKMA PHARMACEUTICALS USA INC. FDA Rx Only

COMBOGESIC IV (acetaminophen and ibuprofen) injection contains acetaminophen and ibuprofen, a nonsteroidal anti-inflammatory drug. Acetaminophen chemical name is N-acetyl-p-aminophenol. Acetaminophen is a white, odorless, crystalline powder, possessing a slightly bitter taste. Acetaminophen is soluble in boiling water and 1N sodium hydroxide and is freely soluble in alcohol. Acetaminophen has a molecular weight of 151.16. The molecular formula is C 8 H 9 NO 2 and the structural formula is: Ibuprofen sodium dihydrate chemical name is 2-(4-isobutyl phenyl) propionic acid sodium salt dihydrate. Ibuprofen sodium dihydrate is a white powder. It has a molecular weight of 264.29. It is freely soluble in water. The molecular formula is C 13 H 21 NaO 4 and the structural formula of ibuprofen sodium dihydrate is represented below: COMBOGESIC IV injection is a sterile, clear, colorless, non-pyrogenic, isotonic solution, intended for intravenous infusion with a pH stability range of 6.3-7.3. Each single-dose 100 mL vial contains 1,000 mg of acetaminophen and 300 mg of ibuprofen base (equivalent to 385 mg of ibuprofen sodium dihydrate), 25 mg of Cysteine hydrochloride monohydrate, 13 mg of Disodium phosphate dihydrate, 3,285 mg of Mannitol, Hydrochloric acid (for pH adjustment), Sodium hydroxide (for pH adjustment), Water for injection. Acetaminophen Structural Formula Ibuprofen Structural Formula

Cyanocobalamin CYANOCOBALAMIN
1000 mcg/ml
HIKMA PHARMACEUTICALS USA INC. FDA Rx Only

Cyanocobalamin Injection (vitamin B 12 ) is a sterile solution of Cyanocobalamin. Each mL contains Cyanocobalamin 1000 mcg, sodium chloride 9 mg and benzyl alcohol 0.015 mL in water for injection. Hydrochloric acid and/or sodium hydroxide may have been added to adjust the pH (range 4.5-7.0). 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
25 mg Capsule
HIKMA PHARMACEUTICALS USA 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 has a 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 and ethanol. Each capsule for oral administration contains 25 mg or 50 mg cyclophosphamide (anhydrous, USP) and the following inactive ingredients: pregelatinized starch and sodium stearyl fumarate. Each gelatin capsule shell contains FD&C Blue #1, FD&C Red #40, gelatin and titanium dioxide. In addition to the ingredients listed above, each capsule contains Opacode (Black) monogramming ink. Opacode (Black) contains ammonium hydroxide, iron oxide black, isopropyl alcohol, N-butyl alcohol, propylene glycol and shellac. Chem Struc

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