eugia us llc - Medication Listings

Browse 141 medications manufactured by eugia us llc. Open a product record to review dosage forms, strengths, packaging, and related navigation.

Oxacillin OXACILLIN SODIUM
EUGIA US LLC FDA Rx Only

Oxacillin for Injection, USP is a semisynthetic penicillin antibiotic derived from 6-amino-penicillanic acid. It is the sodium salt in a parenteral dosage form. Each vial of Oxacillin for Injection, USP contains oxacillin sodium monohydrate equivalent to 1 gram or 2 grams of oxacillin. The sodium content is 57.30 mg [2.5 mEq] per gram oxacillin. The product is buffered with 20 mg sterile disodium hydrogen phosphate per gram oxacillin. Oxacillin for Injection, USP is a sterile, white to off-white powder supplied in vials. Oxacillin sodium, C 19 H 18 N 3 NaO 5 S • H 2 O molecular weight 441.43, is designated as 4-Thia-1-azabicyclo [3.2.0]heptane-2-carboxylic acid, 3,3-dimethyl-6-[[(5-methyl-3-phenyl-4-isoxazolyl) carbonyl] amino]-7-oxo-, monosodium salt, monohydrate, [2 S (2α,5α,6β)] and has the following structural formula: Chemical Structure

Oxacillin OXACILLIN SODIUM
EUGIA US LLC FDA Rx Only

Oxacillin for Injection, USP is a semisynthetic penicillin antibiotic derived from 6-amino-penicillanic acid. It is the sodium salt in a parenteral dosage form. Each Pharmacy Bulk Package of Oxacillin for Injection, USP contains oxacillin sodium monohydrate equivalent to 10 grams of oxacillin. The sodium content is 57.30 mg [2.5 mEq] per gram oxacillin. The product is buffered with 20 mg sterile disodium hydrogen phosphate per gram oxacillin. Oxacillin for Injection, USP is a sterile, white to off-white powder supplied in Pharmacy Bulk Package bottles. Oxacillin sodium, C 19 H 18 N 3 NaO 5 S • H 2 O molecular weight 441.43, is designated as 4-Thia-1-azabicyclo [3.2.0]heptane-2-carboxylic acid, 3,3-dimethyl-6-[[(5-methyl-3-phenyl-4-isoxazolyl) carbonyl] amino]-7-oxo-, monosodium salt, monohydrate, [2 S (2α,5α,6β)] and has the following structural formula: A Pharmacy Bulk Package bottle is a container of a sterile preparation for parenteral use that contains many single doses. The contents of this pharmacy bulk package are intended for use by a pharmacy admixture service for addition to suitable parenteral fluids in the preparation of admixtures for intravenous infusion. (See DOSAGE AND ADMINISTRATION , Directions for Proper Use of Pharmacy Bulk Package .) FURTHER DILUTION IS REQUIRED. Chemical Structure

Oxaliplatin OXALIPLATIN
50 mg Injection
EUGIA US LLC FDA Rx Only

Oxaliplatin injection, USP is a platinum-based drug with the molecular formula C 8 H 14 N 2 O 4 Pt and the chemical name of cis-[(1 R,2 R)- 1,2-cyclohexanediamine -N,N’] [oxalato(2)- O,O’] platinum. Oxaliplatin, USP is an organoplatinum complex in which the platinum atom is complexed with 1,2-diaminocyclohexane (DACH) and with an oxalate ligand as a leaving group. The molecular weight is 397.3. Oxaliplatin, USP is slightly soluble in water at 6 mg/mL, very slightly soluble in methanol, and practically insoluble in ethanol and acetone. Oxaliplatin injection, USP for intravenous use is supplied in vials containing 50 mg, 100 mg of oxaliplatin, USP as a sterile, preservative-free, aqueous solution at a concentration of 5 mg/mL. Water for Injection, USP is present as an inactive ingredient. Chemical Structure

Palonosetron Hydrochloride PALONOSETRON HYDROCHLORIDE
EUGIA US LLC FDA Rx Only

Palonosetron hydrochloride injection contains palonosetron as palonosetron HCl, an antiemetic and antinauseant agent. It is a serotonin-3 (5-HT 3 ) receptor antagonist with a strong binding affinity for this receptor. Chemically, palonosetron hydrochloride is: (3a S )-2-[( S )-1-Azabicyclo [2.2.2]oct-3-yl]-2,3,3a,4,5,6-hexahydro-1-oxo-1 H benz[ de ]isoquinoline hydrochloride. The molecular formula is C 19 H 24 N 2 O•HCl, with a molecular weight of 332.87. Palonosetron hydrochloride exists as a single isomer and has the following structural formula: Palonosetron hydrochloride is a white to off-white crystalline powder. It is freely soluble in water, soluble in propylene glycol, and slightly soluble in ethanol and 2-propanol. Palonosetron hydrochloride injection is a sterile, clear, colorless, non-pyrogenic, isotonic, buffered solution free from visible particles for intravenous administration. Palonosetron hydrochloride injection is available as a 5 mL single-dose vial. Each 5 mL vial contains 0.25 mg palonosetron (equivalent to 0.28 mg palonosetron HCl), 207.5 mg mannitol, disodium edetate and citrate buffer in water for intravenous administration. The pH of the solution in the 5 mL vial is 4.5 to 5.5. Palonosetron Hydrochloride Chemical Structure

PARICALCITOL PARICALCITOL
2 mcg/ml Injection
EUGIA US LLC FDA Rx Only

Paricalcitol USP, is a synthetically manufactured active vitamin D analog. It is a white to almost white powder chemically designated as 19-nor-1α,3β,25-trihydroxy-9,10-secoergosta-5(Z),7(E),22(E)-triene and has the following structural formula: Molecular formula is C 27 H 44 O 3 . Molecular weight is 416.64. Paricalcitol injection, USP is a sterile, clear, colorless, aqueous solution for intravenous use. Each mL contains paricalcitol, 2 mcg or 5 mcg and the following inactive ingredients: alcohol, 20% (v/v) and propylene glycol, 30% (v/v). Chemical Structure

Pemetrexed PEMETREXED
100 mg Injection
EUGIA US LLC FDA Rx Only

Pemetrexed for injection, USP is a folate analog metabolic inhibitor. The drug substance, pemetrexed disodium hemipentahydrate, has the chemical name N -[4-[2-(2-amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3- d ]pyrimidin-5-yl)ethyl]benzoyl]- L-glutamic acid disodium salt hydrate with a molecular formula of C 20 H 19 N 5 Na 2 O 6 •2.5H 2 O and a molecular weight of 516.37. The structural formula is as follows: Pemetrexed for injection, USP is a sterile white-to-light yellow or green-yellow lyophilized powder in single-dose vials to be reconstituted for intravenous infusion. Each 100-mg vial of pemetrexed for injection, USP contains 100 mg pemetrexed (equivalent to 120.81 mg pemetrexed disodium hemipentahydrate) and 106 mg mannitol. Each 500-mg vial of pemetrexed for injection, USP contains 500 mg pemetrexed (equivalent to 604.05 mg pemetrexed disodium hemipentahydrate) and 500 mg mannitol. Each 1,000-mg vial of pemetrexed for injection, USP contains 1,000 mg pemetrexed (equivalent to 1,208.11 mg pemetrexed disodium hemipentahydrate) and 1,000 mg mannitol. Hydrochloric acid and/or sodium hydroxide may have been added to adjust pH. chemical-structure

PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE
EUGIA US LLC FDA Rx Only

Phenylephrine is an alpha-1 adrenergic receptor agonist. Phenylephrine Hydrochloride Injection USP, 10 mg/mL, is a clear, colorless, sterile, nonpyrogenic, aqueous solution for intravenous use. It must be diluted before administration as an intravenous bolus or continuous intravenous infusion. The chemical name of phenylephrine hydrochloride is (-)- m -hydroxy-α-[(methylamino)methyl]benzyl alcohol hydrochloride and is chemically designated as C 9 H 14 ClNO 2 with a molecular weight of 203.67 g/mol. Its structural formula is depicted below: Phenylephrine hydrochloride USP is white or practically white powder. Phenylephrine hydrochloride is soluble in water, and ethanol, and insoluble in chloroform and ethyl ether. Phenylephrine Hydrochloride Injection USP, 10 mg/mL, is sensitive to light. Each mL contains: phenylephrine hydrochloride USP, 10 mg; sodium chloride 3.5 mg; sodium citrate dihydrate 4 mg; citric acid monohydrate 1 mg; and sodium metabisulfite 2 mg in water for injection. The pH is adjusted with sodium hydroxide and/or hydrochloric acid if necessary. The pH range is 3.5 to 5.5. Phenylephrine Hydrochloride Chemical Structure

Phenylephrine Hydrochloride PHENYLEPHRINE HYDROCHLORIDE
EUGIA US LLC FDA Rx Only

Phenylephrine hydrochloride is a synthetic sympathomimetic agent in sterile form for parenteral injection. Chemically, phenylephrine hydrochloride is (-)- m -Hydroxy-α-[(methylamino)methyl]benzyl alcohol hydrochloride and has the following structural formula: Phenylephrine hydrochloride USP is white or practically white powder. Phenylephrine hydrochloride is very soluble in water, freely soluble in ethanol, and insoluble in chloroform and ethyl ether. Phenylephrine hydrochloride is sensitive to light. Phenylephrine hydrochloride injection, USP is a clear, colorless, aqueous solution that is essentially free of visible foreign matter. Each mL contains: Phenylephrine Hydrochloride USP, 10 mg; Sodium Chloride 3.5 mg; Sodium Citrate Dihydrate 4 mg; Citric Acid Monohydrate 1 mg; and Sodium Metabisulfite 2 mg in water for injection. The pH may be adjusted in the range of 3.5 to 5.5 with Sodium Hydroxide and/or Hydrochloric Acid, if necessary. Phenylephrine Hydrochloride Chemical Structure

Piperacillin and Tazobactam PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM
EUGIA US LLC FDA Rx Only

Piperacillin and Tazobactam for Injection, USP is an injectable antibacterial combination product consisting of the semisynthetic antibacterial piperacillin sodium and the beta-lactamase inhibitor tazobactam sodium for intravenous administration. Piperacillin sodium is derived from D(-)-α-aminobenzyl-penicillin. The chemical name of piperacillin sodium is sodium (2 S ,5 R ,6 R )-6-[( R )-2-(4-ethyl-2,3-dioxo-1-piperazine­-carboxamido)-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-­carboxylate. The chemical formula is C 23 H 26 N 5 NaO 7 S and the molecular weight is 539.5. The chemical structure of piperacillin sodium is: Tazobactam sodium, a derivative of the penicillin nucleus, is a penicillanic acid sulfone. Its chemical name is sodium (2 S, 3 S, 5 R )-3-methyl-7-oxo-3-(1 H -1,2,3-triazol-1-ylmethyl)-4-thia-1­-azabicyclo[3.2.0]heptane-2-carboxylate-4,4-dioxide. The chemical formula is C 10 H 11 N 4 NaO 5 S and the molecular weight is 322.3. The chemical structure of tazobactam sodium is: Piperacillin and tazobactam for injection, USP contains a total of 2.35 mEq (54 mg) of sodium (Na + ) per gram of piperacillin in the combination product. Piperacillin and tazobactam for injection, USP is a white to off-white sterile, cryodesiccated powder consisting of piperacillin and tazobactam as their sodium salts packaged in glass vials. Diluted solutions are colorless to yellowish. Each piperacillin and tazobactam for injection, USP 2.25 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 2 g of piperacillin USP and tazobactam sodium equivalent to 0.25 g of tazobactam USP. Each vial contains 4.7 mEq (108 mg) of sodium. Each piperacillin and tazobactam for injection, USP 3.375 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 3 g of piperacillin USP and tazobactam sodium equivalent to 0.375 g of tazobactam USP. Each vial contains 7.05 mEq (162 mg) of sodium. Each piperacillin and tazobactam for injection, USP 4.5 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 4 g of piperacillin USP and tazobactam sodium equivalent to 0.5 g of tazobactam USP. Each vial contains 9.4 mEq (216 mg) of sodium. Meets the USP Organic Impurities Test 4. Piperacillin Chemical Structure Tazobactam Chemical Structure

Piperacillin and Tazobactam PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM
EUGIA US LLC FDA Rx Only

Piperacillin and Tazobactam for Injection, USP is an injectable antibacterial combination product consisting of the semisynthetic antibacterial piperacillin sodium and the beta-lactamase inhibitor tazobactam sodium for intravenous administration. Piperacillin sodium is derived from D(-)-α-aminobenzyl-penicillin. The chemical name of piperacillin sodium is sodium (2 S ,5 R ,6 R )-6-[( R )-2-(4-ethyl-2,3-dioxo-1-piperazine­carboxamido)-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2­carboxylate. The chemical formula is C 23 H 26 N 5 NaO 7 S and the molecular weight is 539.5. The chemical structure of piperacillin sodium is: Tazobactam sodium, a derivative of the penicillin nucleus, is a penicillanic acid sulfone. Its chemical name is sodium (2 S, 3 S, 5 R )-3-methyl-7-oxo-3-(1 H -1,2,3-triazol-1-ylmethyl)-4-thia-1­-azabicyclo[3.2.0]heptane-2-carboxylate-4,4-dioxide. The chemical formula is C 10 H 11 N 4 NaO 5 S and the molecular weight is 322.3. The chemical structure of tazobactam sodium is: Piperacillin and tazobactam for injection, USP contains a total of 2.35 mEq (54 mg) of sodium (Na + ) per gram of piperacillin in the combination product. Piperacillin and tazobactam for injection, USP is a white to off-white sterile, cryodesiccated powder consisting of piperacillin and tazobactam as their sodium salts packaged in glass vials. Each piperacillin and tazobactam for injection, USP 13.5 g pharmacy bulk vial contains piperacillin sodium equivalent to 12 grams of piperacillin and tazobactam sodium equivalent to 1.5 grams of tazobactam sufficient for delivery of multiple doses. Each piperacillin and tazobactam for injection, USP 40.5 g pharmacy bulk vial contains piperacillin sodium equivalent to 36 grams of piperacillin and tazobactam sodium equivalent to 4.5 grams of tazobactam sufficient for delivery of multiple doses. Meets the USP Organic Impurities Test 4. piperatazo-structure-1 piperatazo-structure-2

Piperacillin and Tazobactam PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM
EUGIA US LLC FDA Rx Only

Piperacillin and Tazobactam for Injection, USP is an injectable antibacterial combination product consisting of the semisynthetic antibacterial piperacillin sodium and the beta-lactamase inhibitor tazobactam sodium for intravenous administration. Piperacillin sodium is derived from D(-)-α-aminobenzyl-penicillin. The chemical name of piperacillin sodium is sodium (2 S ,5 R ,6 R )-6-[( R )-2-(4-ethyl-2,3-dioxo-1-piperazine­-carboxamido)-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-­carboxylate. The chemical formula is C 23 H 26 N 5 NaO 7 S and the molecular weight is 539.5. The chemical structure of piperacillin sodium is: Tazobactam sodium, a derivative of the penicillin nucleus, is a penicillanic acid sulfone. Its chemical name is sodium (2 S, 3 S, 5 R )-3-methyl-7-oxo-3-(1 H -1,2,3-triazol-1-ylmethyl)-4-thia-1­-azabicyclo[3.2.0]heptane-2-carboxylate-4,4-dioxide. The chemical formula is C 10 H 11 N 4 NaO 5 S and the molecular weight is 322.3. The chemical structure of tazobactam sodium is: Piperacillin and tazobactam for injection, USP contains a total of 2.35 mEq (54 mg) of sodium (Na + ) per gram of piperacillin in the combination product. Piperacillin and tazobactam for injection, USP is a white to off-white sterile, cryodesiccated powder consisting of piperacillin and tazobactam as their sodium salts packaged in glass vials. Diluted solutions are colorless to yellowish. Each piperacillin and tazobactam for injection, USP 2.25 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 2 g of piperacillin USP and tazobactam sodium equivalent to 0.25 g of tazobactam USP. Each vial contains 4.7 mEq (108 mg) of sodium. Each piperacillin and tazobactam for injection, USP 3.375 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 3 g of piperacillin USP and tazobactam sodium equivalent to 0.375 g of tazobactam USP. Each vial contains 7.05 mEq (162 mg) of sodium. Each piperacillin and tazobactam for injection, USP 4.5 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 4 g of piperacillin USP and tazobactam sodium equivalent to 0.5 g of tazobactam USP. Each vial contains 9.4 mEq (216 mg) of sodium. Meets the USP Organic Impurities Test 4. Piperacillin Chemical Structure Tazobactam Chemical Structure

Plerixafor PLERIXAFOR
24 mg/1.2 ml Injection
EUGIA US LLC FDA Rx Only

Plerixafor injection is a sterile, preservative-free, clear, colorless to pale-yellow, isotonic solution for subcutaneous injection. Each mL of the sterile solution contains 20 mg of plerixafor. Each single-dose vial is filled to deliver 1.2 mL of the sterile solution that contains 24 mg of plerixafor and 5.9 mg of sodium chloride in Water for Injection adjusted to a pH of 6.0 to 7.5 with hydrochloric acid and with sodium hydroxide, if required. Plerixafor is a hematopoietic stem cell mobilizer with a chemical name 1,4-Bis((1,4,8,11­-tetraazacyclotetradecan-1-yl)methyl)benzene. It has the molecular formula C 28 H 54 N 8 . The molecular weight of plerixafor is 502.79 g/mol. The structural formula is provided in Figure 1. Figure 1: Structural Formula Plerixafor is a white to off-white powder. It is hygroscopic. Plerixafor has a typical melting point of 131.5°C. The partition coefficient of plerixafor between 1-octanol and pH 7 aqueous buffer is <0.1. Structural Formula

Polymyxin B POLYMYXIN B
500000 unit
EUGIA US LLC FDA Rx Only

Polymyxin B for Injection, USP is one of a group of basic polypeptide antibiotics derived from B polymyxa (B aerosporous) . Polymyxin B sulfate is the sulfate salt of Polymyxins B 1 and B 2 , which are produced by the growth of Bacillus polymyxa (Prazmowski) Migula (Fam. Bacillacea). Polymyxin B sulfate, USP is a white or off-white powder. It has a potency of not less than 6,000 polymyxin B units per mg, calculated on the anhydrous basis. The structural formulae are: Each vial contains 500,000 polymyxin B units for parenteral or ophthalmic administration. Polymyxin B for Injection, USP is a sterile, white lyophilized cake or powder, suitable for preparation of sterile solutions for intramuscular, intravenous drip, intrathecal, or ophthalmic use. In the medical literature, dosages have frequently been given in terms of equivalent weights of pure polymyxin B base. Each milligram of pure polymyxin B base is equivalent to 10,000 units of polymyxin B and each microgram of pure polymyxin B base is equivalent to 10 units of polymyxin B. Aqueous solutions of polymyxin B sulfate may be stored up to 12 months without significant loss of potency if kept under refrigeration. In the interest of safety, solutions for parenteral use should be stored under refrigeration and any unused portion should be discarded after 72 hours. Polymyxin B sulfate should not be stored in alkaline solutions since they are less stable. Polymyxin B Sulfate Chemical Structure

POSACONAZOLE POSACONAZOLE
300 mg Injection
EUGIA US LLC FDA Rx Only

Posaconazole injection is an azole antifungal agent available as concentrated solution to be diluted before intravenous administration. Posaconazole is designated chemically as 4-[4-[4-[4-[[ (3 R ,5 R )-5- (2,4-difluorophenyl)tetrahydro-5­-(1 H -1,2,4-triazol-1-ylmethyl)-3-furanyl]methoxy]phenyl]-1-piperazinyl]phenyl]-2-[(1 S ,2 S )-1-ethyl-2-­hydroxypropyl]-2,4-dihydro-3 H -1,2,4-triazol-3-one with an molecular formula of C 37 H 42 F 2 N 8 O 4 and a molecular weight of 700.78. The chemical structure is: Posaconazole is a white to off-white crystalline powder with a low aqueous solubility. Posaconazole Injection Posaconazole injection is available as a clear colorless to yellow, sterile liquid essentially free of foreign matter. Each vial contains 300 mg of posaconazole and the following inactive ingredients: 6.68 g Betadex Sulfobutyl Ether Sodium (SBECD), 0.0033 g edetate disodium, hydrochloric acid and sodium hydroxide to adjust the pH to 2.6 and water for injection. Chemical Structure

Prochlorperazine Edisylate PROCHLORPERAZINE EDISYLATE
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Prochlorperazine edisylate, 2-Chloro-10-[3-(4-methyl-1-piperazinyl)propyl]phenothiazine 1,2-ethanedisulfonate (1:1), has the following structural formula: Prochlorperazine edisylate injection, USP an antiemetic and antipsychotic, is a sterile solution intended for intramuscular or intravenous administration. Each mL contains prochlorperazine edisylate, USP equivalent to prochlorperazine 5 mg, monobasic sodium phosphate monohydrate 5 mg, sodium tartrate dihydrate 12 mg, saccharin sodium 0.9 mg and benzyl alcohol 7.5 mg in water for injection. pH 4.2 to 6.2. Chemical Structure

Progesterone PROGESTERONE
500 mg/10 ml
EUGIA US LLC FDA Rx Only

Progesterone injection USP, a progestin, is a sterile solution of progesterone in a suitable vegetable oil available for intramuscular use. Progesterone occurs as a white or creamy white, crystalline powder or colourless crystals. It is soluble in alcohol, in acetone, and in dioxane; sparingly soluble in vegetable oils; practically insoluble in water. It has the following structural formula: Pregn-4-ene-3, 20-dione Each mL contains: Progesterone 50 mg, Benzyl Alcohol 10% as preservative in Sesame Oil q.s. chemical-structure

regadenoson REGADENOSON
0.4 mg/5 ml Injection
EUGIA US LLC FDA Rx Only

Regadenoson is an A 2A adenosine receptor agonist that is a coronary vasodilator [see Clinical Pharmacology (12.1) ] . Regadenoson is chemically described as 2-[4-[(methylamino)carbonyl]-1H-pyrazol-1-yl] adenosine. Its structural formula is: The molecular formula for regadenoson is C 15 H 18 N 8 O 5 and its molecular weight is 390.35. Regadenoson injection is a sterile, nonpyrogenic solution for intravenous injection. The solution is clear and colorless. Each 1 mL in the 5 mL prefilled syringe contains 0.08 mg regadenoson on an anhydrous basis, 10.9 mg dibasic sodium phosphate dihydrate, 5.4 mg monobasic sodium phosphate monohydrate, 150 mg propylene glycol, 1 mg edetate disodium dihydrate and Water for Injection, with pH between 6.3 and 7.7. ragadenoson-structure

Rocuronium Bromide ROCURONIUM BROMIDE
50 mg/5 ml Injection
EUGIA US LLC FDA Rx Only

Rocuronium bromide injection is a nondepolarizing neuromuscular blocking agent with a rapid to intermediate onset depending on dose and intermediate duration. Rocuronium bromide is chemically designated as 1-[17β-(acetyloxy)-3α-hydroxy-2β-(4-morpholinyl)-5α-androstan-16β-yl]-1-(2-propenyl) pyrrolidinium bromide. The structural formula is: Rocuronium bromide USP is an almost white or pale yellow, hygroscopic powder. The chemical formula is C 32 H 53 BrN 2 O 4 with a molecular weight of 609.70. The partition coefficient of rocuronium bromide in n-octanol/water is 0.5 at 20°C. Rocuronium bromide injection is supplied as a sterile, nonpyrogenic, isotonic, clear colorless to yellow or orange solution free from visible particles for intravenous injection only. Each mL contains 10 mg rocuronium bromide USP (equivalent to 8.69 mg rocuronium) and 2 mg sodium acetate. The aqueous solution is adjusted to isotonicity with sodium chloride and to a pH of 4 with acetic acid and/or sodium hydroxide. Rocuronium Bromide Chemical Structure

Ropivacaine Hydrochloride ROPIVACAINE HYDROCHLORIDE
40 mg/20 ml Injection
EUGIA US LLC FDA Rx Only

Ropivacaine hydrochloride injection, USP is a sterile, isotonic solution that contains ropivacaine hydrochloride as the active pharmaceutical ingredient. Ropivacaine hydrochloride is a member of the amino amide class of local anesthetics. Ropivacaine hydrochloride injection, USP is administered parenterally by for infiltration, epidural, and nerve block. Ropivacaine hydrochloride, USP is chemically described as S-(-)-1-propyl-2’,6’-pipecoloxylidide hydrochloride monohydrate. The drug substance is a white crystalline powder, with the following structural formula: ' C 17 H 26 N 2 O•HCl•H 2 O M.W. 328.89 At 25°C ropivacaine hydrochloride has a solubility of 53.8 mg/mL in water, a distribution ratio between n -octanol and phosphate buffer at pH 7.4 of 14:1 and a pKa of 8.07 in 0.1 M KCl solution. The pKa of ropivacaine is approximately the same as bupivacaine (8.1) and is similar to that of mepivacaine (7.7). However, ropivacaine has an intermediate degree of lipid solubility compared to bupivacaine and mepivacaine. Ropivacaine hydrochloride injection, USP is a clear, colorless, and preservative-free solution. Each mL contains 2.1 mg, 5.3 mg, 7.9 mg or 10.6 mg ropivacaine hydrochloride monohydrate (equivalent to 2.0 mg, 5.0 mg, 7.5 mg or 10 mg of ropivacaine hydrochloride anhydrous), and 8.6 mg, 8.0 mg, 7.5 mg or 7.1 mg of sodium chloride; respectively, and sodium hydroxide and hydrochloric acid as pH adjusters, in water for injection. The pH is adjusted between 4.0 to 6.0. The specific gravity of ropivacaine hydrochloride injection, USP solutions range from 1.002 to 1.005 at 25°C. chemical-structure

Sildenafil SILDENAFIL CITRATE
(SILDENAFIL CITR...) 10 mg/12.5 ml Injection
EUGIA US LLC FDA Rx Only

Sildenafil injection, phosphodiesterase-5 (PDE-5) inhibitor, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type-5 (PDE-5). Sildenafil is also marketed as VIAGRA ® for erectile dysfunction. Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1 H -pyrazolo [4,3- d ] pyrimidin-5-yl)-4-ethoxyphenyl] sulfonyl]-4-methylpiperazine citrate and has the following structural formula: Sildenafil citrate USP is a white or almost white slightly hygroscopic crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7. Sildenafil injection is supplied as a clear, colorless, sterile, ready to use solution in a single-dose vial containing 10 mg/12.5 mL of sildenafil. Each mL of solution contains 1.124 mg sildenafil citrate USP equivalent to 0.8 mg sildenafil, 50.5 mg dextrose and water for injection. Sildenafil Citrate Chemical Structure

SUCCINYLCHOLINE CHLORIDE SUCCINYLCHOLINE CHLORIDE
200 mg/10 ml Injection
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Succinylcholine chloride injection, USP is a sterile, nonpyrogenic solution to be used as a short-acting, depolarizing neuromuscular blocker for intravenous or intramuscular use. Succinylcholine chloride injection, USP contains succinylcholine chloride, USP as the active pharmaceutical ingredient. Succinylcholine chloride, USP is chemically designated C 14 H 30 Cl 2 N 2 O 4 .2H 2 O and its molecular weight is 397.34. The chemical name of succinylcholine chloride, USP is 2,2'-[(1,4-dioxo-1,4 butanediyl)bis(oxy)]bis[N,N,N-trimethyl-ethanaminium]dichloride. Succinylcholine chloride, USP is a diquaternary base consisting of the dichloride salt of the dicholine ester of succinic acid. It is a white, odorless, slightly bitter powder, very soluble in water. It has the following structural formula: Succinylcholine chloride injection USP, 200 mg/10 mL (20 mg/mL) is intended for multiple-dose administration and contains preservative. Each 1 mL of succinylcholine chloride injection USP, 200 mg/10 mL (20 mg/mL) multiple-dose fliptop vials contains: 20 mg of succinylcholine chloride, USP (equivalent to 22 mg of succinylcholine chloride dihydrate, USP), 1.8 mg of methylparaben and 0.2 mg of propylparaben as preservatives, 4.6 mg of sodium chloride as iso-osmotic agent, and sodium hydroxide and hydrochloric acid as pH adjusters in water for injection. The pH of the solution is between 3.0 and 4.5, with an osmolarity of 0.338 mOsm/mL (calc.). chemical-structure

Sumatriptan SUMATRIPTAN
6 mg Injection
EUGIA US LLC FDA Rx Only

Sumatriptan Injection USP contains sumatriptan succinate, a selective 5-HT 1B/1D receptor agonist. Sumatriptan succinate is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1), and it has the following structure: The molecular formula is C 14 H 21 N 3 O 2 S • C 4 H 6 O 4 , representing a molecular weight of 413.5. Sumatriptan succinate USP is a white or almost white powder that is readily soluble in water and in saline. Sumatriptan injection USP is a clear, colorless to pale yellow, sterile, nonpyrogenic solution for subcutaneous injection. Each 0.5 mL of sumatriptan injection USP 12 mg/mL solution contains 8.4 mg of sumatriptan succinate equivalent to 6 mg of sumatriptan and 3.5 mg of sodium chloride, USP in Water for Injection, USP. The pH range of the solution is approximately 4.2 to 5.3. The osmolality of the injection is 291 mOsmol. Sumatriptan Chemical Structure

Sumatriptan SUMATRIPTAN
6 mg Injection
EUGIA US LLC FDA Rx Only

Sumatriptan Injection USP contains sumatriptan succinate, a selective 5-HT 1B/1D receptor agonist. Sumatriptan succinate is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1), and it has the following structure: The molecular formula is C 14 H 21 N 3 O 2 S • C 4 H 6 O 4 , representing a molecular weight of 413.5. Sumatriptan succinate USP is a white or almost white powder that is readily soluble in water and in saline. Sumatriptan injection USP is a clear, colorless to pale yellow, sterile, nonpyrogenic solution for subcutaneous injection. Each 0.5 mL of sumatriptan injection USP 12 mg/mL solution contains 8.4 mg of sumatriptan succinate equivalent to 6 mg of sumatriptan and 3.5 mg of sodium chloride, USP in Water for Injection, USP. The pH range of the solution is approximately 4.2 to 5.3. The osmolality of the injection is 291 mOsmol. Sumatriptan Succinate Chemical Structure

Testosterone Cypionate TESTOSTERONE CYPIONATE
EUGIA US LLC FDA Rx Only

Testosterone Cypionate Injection USP, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone. Testosterone cypionate USP is a white or creamy white crystalline powder. It is insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils. The chemical name for testosterone cypionate is androst-4-en-3-one, 17-(3-cyclopentyl-1-oxopropoxy)-, (17ß)-. Its molecular formula is C 27 H 40 O 3 , and the molecular weight 412.61. The structural formula is represented below: Testosterone Cypionate Injection, USP is a clear, pale yellow to yellowish oily solution and is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate. Each mL of the 100 mg/mL solution contains: Testosterone cypionate USP................................................................................ 100 mg (equivalent to 69.90 mg Testosterone) Benzyl benzoate ................................................................................................... 0.1 mL Cottonseed oil ...................................................................................................... 736 mg Benzyl alcohol (as preservative) ........................................................................ 9.45 mg Each mL of the 200 mg/mL solution contains: Testosterone cypionate USP................................................................................. 200 mg (equivalent to 139.8 mg Testosterone) Benzyl benzoate ................................................................................................... 0.2 mL Cottonseed oil ...................................................................................................... 560 mg Benzyl alcohol (as preservative) ......................................................................... 9.45 mg Chemical Structure

TESTOSTERONE ENANTHATE TESTOSTERONE ENANTHATE
EUGIA US LLC FDA Rx Only

Testosterone enanthate injection, USP provides testosterone enanthate, a derivative of the primary endogenous androgen testosterone, for intramuscular administration. In their active form, androgens have a 17-beta-hydroxy group. Esterification of the 17-beta-hydroxy group increases the duration of action of testosterone; hydrolysis to free testosterone occurs in vivo . Each mL of sterile, clear colorless to pale yellow color oily solution provides 200 mg testosterone enanthate, USP in sesame oil with 5 mg chlorobutanol (chloral derivative) as a preservative. Testosterone enanthate is designated chemically as androst-4-en-3-one, 17-[(1-oxoheptyl)-oxy]-, (17β)-. Structural formula: Chemical Structure

Thiamine Hydrochloride THIAMINE HYDROCHLORIDE
EUGIA US LLC FDA Rx Only

Thiamine Hydrochloride Injection, USP is a sterile, clear and colorless to pale yellow color solution of thiamine hydrochloride in Water for Injection for intramuscular (IM) or slow intravenous (IV) administration. Each mL contains: Thiamine hydrochloride USP 100 mg; monothioglycerol 0.5%; water for injection q.s. Sodium hydroxide may have been added for pH adjustment (2.5 to 4.5). Thiamine hydrochloride USP, or vitamin B 1 , occurs as white crystals or crystalline powder that usually has a slight characteristic odor. Freely soluble in water; soluble in glycerin; slightly soluble in alcohol; insoluble in ether and benzene. Thiamine is rapidly destroyed in neutral or alkaline solutions but is stable in the dry state. It is reasonably stable to heat in acid solution. The chemical name of thiamine hydrochloride is thiazolium,3-[(4-amino-2-methyl-5-pyrimidinyl)methyl]-5-(2-hydroxyethyl)-4-methylchloride, monohydrochloride and it has the following structural formula: Thiamine Hydrochloride Chemical Structure

Tigecycline TIGECYCLINE
10 ml Injection
EUGIA US LLC FDA Rx Only

Tigecycline for injection, USP is a tetracycline class antibacterial for intravenous infusion. The chemical name of tigecycline is (4 S ,4a S ,5a R ,12a S )-9-[2-( tert -butylamino)acetamido]-4,7­-bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide. The molecular formula is C 29 H 39 N 5 O 8 and the molecular weight is 585.65. Tigecycline USP is an orange powder. The following represents the chemical structure of tigecycline: Figure 1: Structure of Tigecycline Tigecycline for injection, USP is an orange colored lyophilized cake or powder. Each single-dose 10 mL vial contains 50 mg tigecycline lyophilized powder for reconstitution for intravenous infusion and 100 mg of lactose monohydrate. The pH is adjusted with hydrochloric acid, and if necessary sodium hydroxide. The product does not contain preservatives. FDA approved acceptance criteria for assay differs from USP test. Tigecycline Chemical Structure

Tirofiban TIROFIBAN
5 mg/100 ml Injection
EUGIA US LLC FDA Rx Only

Tirofiban hydrochloride injection contains tirofiban hydrochloride, a non-peptide antagonist of the platelet GP IIb/IIIa receptor, which inhibits platelet aggregation. Tirofiban hydrochloride monohydrate is chemically described as N- (butylsulfonyl)- O -[4-(4- piperidinyl)butyl]-L-tyrosine hydrochloride monohydrate. Its molecular formula is C 22 H 36 N 2 O 5 S•HCl•H 2 O and its structural formula is: Tirofiban hydrochloride monohydrate is a off-white, non-hygroscopic, free-flowing powder, with a molecular weight of 495.07. It is very slightly soluble in water. Tirofiban hydrochloride injection premixed is supplied as a sterile solution in water for injection, for intravenous use. The pH of the solution ranges from 5.5 to 6.5 adjusted with hydrochloric acid and/or sodium hydroxide. Each 100 mL of the premixed, isosmotic intravenous injection contains 5.618 mg tirofiban hydrochloride monohydrate equivalent to 5 mg tirofiban (50 mcg/mL) and the following inactive ingredients: 0.9 g sodium chloride, 54 mg sodium citrate dihydrate, and 3.2 mg citric acid anhydrous. Each 250 mL of the premixed, isosmotic intravenous injection contains 14.045 mg tirofiban hydrochloride monohydrate equivalent to 12.5 mg tirofiban (50 mcg/mL) and the following inactive ingredients: 2.25 g sodium chloride, 135 mg sodium citrate dihydrate, and 8 mg citric acid anhydrous. chemical-structure

TOBRAMYCIN TOBRAMYCIN
EUGIA US LLC FDA Rx Only

Tobramycin sulfate, a water-soluble antibiotic of the aminoglycoside group, is derived from the actinomycete Streptomyces tenebrarius . Tobramycin for injection, USP is supplied as a sterile white to off-white lyophilized powder or cake and is intended for reconstitution with 30 mL of Sterile Water for Injection, USP. Sulfuric acid and/or sodium hydroxide may have been added during manufacture to adjust the pH between 6.0 and 8.0. Each vial contains tobramycin sulfate equivalent to 1,200 mg of tobramycin, USP. After reconstitution, the solution will contain 40 mg of tobramycin, USP per mL. The product contains no preservative or sodium bisulfite. Tobramycin sulfate is, O -3-amino-3-deoxy-α-D-glucopyranosyl-(1→4)- O -[2,6-diamino-2,3,6-trideoxy-α-D -ribo- hexopyranosyl-(1→6)]-2-deoxy-L-streptamine, sulfate (2:5) (salt) and has the molecular formula (C 18 H 37 N 5 O 9 )2•5H 2 SO 4 . The molecular weight is 1,425.45. The structural formula for tobramycin, USP is as follows: 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 (see DOSAGE AND ADMINISTRATION , Directions for proper use of Pharmacy Bulk Package ). tobramycin-str

Tranexamic Acid TRANEXAMIC ACID
1000 mg/10 ml Injection
EUGIA US LLC FDA Rx Only

Tranexamic acid is trans-4-(aminomethyl)cyclohexanecarboxylic acid, an antifibrinolytic agent. Tranexamic acid USP is a white or almost white, crystalline powder. The structural formula is Molecular Formula: C 8 H 15 NO 2 Molecular Weight: 157.2 Each mL of the sterile, clear, colorless solution for intravenous injection contains 100 mg tranexamic acid USP and water for injection to 1 mL. The aqueous solution for injection has a pH of 6.5 to 8.0. tranexamic-acid-structure

Triamcinolone Acetonide TRIAMCINOLONE ACETONIDE
EUGIA US LLC FDA Rx Only

Triamcinolone acetonide injectable suspension, USP is a synthetic glucocorticoid corticosteroid with anti-inflammatory action. THIS FORMULATION IS SUITABLE FOR INTRAMUSCULAR AND INTRA-ARTICULAR USE ONLY. THIS FORMULATION IS NOT FOR INTRADERMAL INJECTION. Triamcinolone acetonide injectable suspension, USP: Each mL of the sterile aqueous suspension provides 40 mg triamcinolone acetonide, USP with 0.65% sodium chloride for isotonicity, 0.99% (w/v) benzyl alcohol as a preservative, 0.75% carboxymethylcellulose sodium, and 0.04% polysorbate 80. Sodium hydroxide or hydrochloric acid may be present to adjust pH to 5.0 to 7.5. At the time of manufacture, the air in the container is replaced by nitrogen. The chemical name for triamcinolone acetonide is 9-Fluoro-11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone. Its structural formula is: Triamcinolone acetonide, USP occurs as a white or almost-white, crystalline powder, practically insoluble in water, sparingly soluble in ethanol, methanol and chloroform, very slightly soluble in ether. Chemical Structure

Vancomycin hydrochloride VANCOMYCIN HYDROCHLORIDE
EUGIA US LLC FDA Rx Only

Vancomycin hydrochloride for injection, USP, contains the hydrochloride salt of vancomycin, a tricyclic glycopeptide antibacterial derived from Amycolatopsis orientalis (formerly Nocardia orientalis) . The chemical name for vancomycin hydrochloride, USP is (Sa)-(3 S ,6 R ,7 R ,22 R ,23 S ,26 S ,36 R ,38a R )-44-[[2 -O- (3-Amino-2,3,6-trideoxy-3 -C- methyl-α-L-lyxo­-hexopyranosyl)-β-D-glucopyranosyl]oxy]-3-(carbamoylmethyl)-10,19-dichloro-­2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[(2 R )-4-­methyl-2-(methylamino)valeramido]-2,5,24,38,39-pentaoxo-22 H -8,11:18,21-dietheno-23,36­-(iminomethano)-13,16:31,35-dimetheno-1 H ,16 H -[l,6,9]oxadiazacyclohexadecino[4,5-­m][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C 66 H 75 Cl 2 N 9 O 24 ꞏHCl and the molecular weight is 1,485.71. Vancomycin hydrochloride, USP has the following structural formula: Vancomycin hydrochloride for injection, USP is a sterile white or off-white to light tan colored lyophilized cake or powder for injection. Vancomycin hydrochloride for injection, USP is supplied in single-dose vials, containing 1.28 g or 1.54 g of vancomycin hydrochloride, USP equivalent to 1.25 g or 1.5 g of vancomycin base. The lyophilized powder is reconstituted with sterile water for injection, USP which forms a clear, colorless to light tan color solution and subsequently diluted prior to intravenous administration [see Dosage and Administration (2.5) ]. vancomycin-structure

Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE
EUGIA US LLC FDA Rx Only

Vancomycin Hydrochloride for Injection, USP is a white or off-white to light tan sterile, lyophilized and preservative free powder or cake, for preparing intravenous (IV) infusions, in vials each containing the equivalent of 500 mg or 1 g vancomycin base. 500 mg of the base are equivalent to 0.34 mmol. When reconstituted with Sterile Water for Injection to a concentration of 50 mg/mL, the pH of the solution is between 2.5 and 4.5. This product is oxygen sensitive. Vancomycin Hydrochloride for Injection, USP should be administered intravenously in diluted solution (see DOSAGE AND ADMINISTRATION ), AFTER RECONSTITUTION FURTHER DILUTION IS REQUIRED BEFORE USE. Vancomycin is a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis ). Vancomycin hydrochloride USP is a white or almost white, hygroscopic powder. The chemical name for vancomycin hydrochloride is 3S-[3 R *,6 S *( S *),7 S *,22 S *,23 R *,26 R *,36 S *,38a S *]]-3-(2-Amino-2-oxoethyl)-44-[[2-O-(3-amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-ß-D-glucopyranosyl]oxy]-10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[[4-methyl-2-(methylamino)-1-oxopentyl]amino]-2,5,24,38,39-pentaoxo-22 H -8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1 H ,16 H -[1,6,9]oxadiazacyclohexadecino[4,5- m ][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C 66 H 75 Cl 2 N 9 O 24 • HCl and the molecular weight is 1,485.74. Vancomycin hydrochloride has the following structural formula: Structure

Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE
EUGIA US LLC FDA Rx Only

Vancomycin hydrochloride for injection, USP is a white or off-white to light tan sterile, lyophilized powder or cake, for preparing intravenous (IV) infusions, in Pharmacy Bulk Package bottles containing the equivalent of 5 g or 10 g vancomycin base. 500 mg of the base are equivalent to 0.34 mmol. When reconstituted with Sterile Water for Injection to a concentration of 50 mg/mL for the 5 g Pharmacy Bulk Package bottle and 100 mg/mL for the 10 g Pharmacy Bulk Package bottle, the pH of the solution is between 2.5 and 4.5. Vancomycin hydrochloride for injection, USP should be administered intravenously in diluted solution (see DOSAGE AND ADMINISTRATION ). Vancomycin is a tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis ). Vancomycin hydrochloride USP is a white or almost white, hygroscopic powder. The chemical name for vancomycin hydrochloride is 3S-[3R*,6S*(S*),7S*,22S*,23R*,26R*,36S*,38aS*]]-3-(2-Amino-2-oxoethyl)-44-[[2-O-(3-amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)- ß -D-glucopyranosyl] oxy] -10,19-dichloro-2,3,4,5,6,7,23,24,25,26,36,37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[[4-methyl-2-(methylamino)-1-oxopentyl]amino]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36-(iminomethano)-13,16:31,35-dimetheno-1H,16H-[1,6,9]oxadiazacyclohexadecino[4,5-m][10,2,16]-benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C 66 H 75 C l2 N 9 O 24 • HCl and the molecular weight is 1,485.74. Vancomycin hydrochloride has the following structural formula: A pharmacy bulk package is a sterile dosage form containing many single doses. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for IV infusion. AFTER RECONSTITUTIO N FURTHER DILUTION IS REQUIRED BEFORE USE. Vancomycin Hydrochloide Chemical Structure

VASOPRESSIN VASOPRESSIN
20 unit/ml Injection
EUGIA US LLC FDA Rx Only

Vasopressin is a polypeptide hormone. Vasopressin injection USP, is a sterile, clear, practically colorless aqueous solution of synthetic arginine vasopressin for intravenous administration. The 1 mL solution contains vasopressin 20 units/mL, chlorobutanol, NF 0.5% as a preservative and Water for Injection, USP adjusted with glacial acetic acid, USP to pH 3.0 to 3.4. The chemical name of vasopressin is Cyclo (1-6) L-Cysteinyl-L-Tyrosyl-L-Phenylalanyl­-L-Glutaminyl-L-Asparaginyl-L-Cysteinyl-L-Prolyl-L-Arginyl-L-Glycinamide. It is a white to off-white amorphous powder, freely soluble in water. The structural formula is: Molecular Formula: C 46 H 65 N 15 O 12 S 2 Molecular Weight: 1084.24 Daltons One mg is equivalent to 530 units. Chemical Structure

VASOPRESSIN VASOPRESSIN
20 unit/ml Injection
EUGIA US LLC FDA Rx Only

Vasopressin is a polypeptide hormone. Vasopressin injection USP, is a sterile, clear, practically colorless aqueous solution of synthetic arginine vasopressin for intravenous administration. The 1 mL solution contains vasopressin 20 units/mL, chlorobutanol, NF 0.5% as a preservative and Water for Injection, USP adjusted with glacial acetic acid, USP to pH 3.0 to 3.4. The chemical name of vasopressin is Cyclo (1-6) L-Cysteinyl-L-Tyrosyl-L-Phenylalanyl­-L-Glutaminyl-L-Asparaginyl-L-Cysteinyl-L-Prolyl-L-Arginyl-L-Glycinamide. It is a white to off-white amorphous powder, freely soluble in water. The structural formula is: Molecular Formula: C 46 H 65 N 15 O 12 S 2 Molecular Weight: 1084.24 Daltons One mg is equivalent to 530 units. Chemical Structure

VECURONIUM BROMIDE VECURONIUM BROMIDE
EUGIA US LLC FDA Rx Only

Vecuronium Bromide for Injection is a nondepolarizing neuromuscular blocking agent of intermediate duration, chemically designated as 1-(3α,17β-Dihydroxy-2β-piperidino-5α-androstan-16β,5α-yl)-1-methylpiperidinium bromide, diacetate. Vecuronium Bromide USP is a white or creamy white crystalline powder. The structural formula is: Its chemical formula is C 34 H 57 BrN 2 O 4 with molecular weight 637.75. Vecuronium Bromide for Injection is supplied as a sterile, nonpyrogenic, white to off-white lyophilized cake or powder for intravenous injection only. Each 10 mL vial contains 10 mg of vecuronium bromide USP, 20.75 mg citric acid anhydrous, 16.25 mg dibasic sodium phosphate anhydrous, 97 mg mannitol (to adjust tonicity), sodium hydroxide and/or phosphoric acid to buffer and adjust to a pH range of 3.5 to 4.5. Each 20 mL vial contains 20 mg of vecuronium bromide USP, 41.5 mg citric acid anhydrous, 32.5 mg dibasic sodium phosphate anhydrous, 194 mg mannitol (to adjust tonicity), sodium hydroxide and/or phosphoric acid to buffer and adjust to a pH range of 3.5 to 4.5. Vecuronium Bromide Chemcal Structure

VECURONIUM BROMIDE VECURONIUM BROMIDE
EUGIA US LLC FDA Rx Only

Vecuronium Bromide for Injection is a nondepolarizing neuromuscular blocking agent of intermediate duration, chemically designated as 1-(3α,17β-Dihydroxy-2β-piperidino-5α-androstan-16β,5α-yl)-1-methylpiperidinium bromide, diacetate. Vecuronium Bromide USP is a white or creamy white crystalline powder. The structural formula is: Its chemical formula is C 34 H 57 BrN 2 O 4 with molecular weight 637.75. Vecuronium Bromide for Injection is supplied as a sterile, nonpyrogenic, white to off-white lyophilized cake or powder for intravenous injection only. Each 10 mL vial contains 10 mg of vecuronium bromide USP, 20.75 mg citric acid anhydrous, 16.25 mg dibasic sodium phosphate anhydrous, 97 mg mannitol (to adjust tonicity), sodium hydroxide and/or phosphoric acid to buffer and adjust to a pH range of 3.5 to 4.5. Each 20 mL vial contains 20 mg of vecuronium bromide USP, 41.5 mg citric acid anhydrous, 32.5 mg dibasic sodium phosphate anhydrous, 194 mg mannitol (to adjust tonicity), sodium hydroxide and/or phosphoric acid to buffer and adjust to a pH range of 3.5 to 4.5. Vecuronium Bromide Chemcal Structure

VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE
EUGIA US LLC FDA Rx Only

Verapamil hydrochloride is a calcium antagonist or slow channel inhibitor. Verapamil hydrochloride injection, USP is a sterile, clear colorless solution and is available in 5 mg/2 mL and 10 mg/4 mL single-dose vials (for intravenous administration). Each 1 mL of solution contains 2.5 mg verapamil hydrochloride, USP and 8.5 mg sodium chloride in water for injection. Hydrochloric acid and/or sodium hydroxide is used for pH adjustment. The pH of solution is between 4.0 and 6.5. Protect contents from light. Verapamil hydrochloride injection, USP vials are sterile. The structural formula of verapamil hydrochloride is given below: The chemical name of verapamil hydrochloride is Benzeneacetonitrile, α-[3-[[2-(3,4-dimethoxyphenyl)ethyl] methylamino] propyl]-3,4-dimethoxy-α-(1-methylethyl) hydrochloride. Verapamil hydrochloride, USP is white or practically white, crystalline powder. It is soluble in water, freely soluble in chloroform, sparingly soluble in alcohol, practically insoluble in ether. Verapamil hydrochloride is not chemically related to other antiarrhythmic drugs. Chemical Structure

Voriconazole VORICONAZOLE
200 mg Injection
EUGIA US LLC FDA Rx Only

Voriconazole, an azole antifungal agent is available as a lyophilized powder for solution for intravenous infusion. The structural formula is: Voriconazole USP is designated chemically as (2R,3S)-2-(2,4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1 H -1,2,4-triazol-1-yl)-2-butanol with a molecular formula of C 16 H 14 F 3 N 5 O and a molecular weight of 349.3. Voriconazole USP drug substance is a white or almost white powder. Voriconazole for injection is a white lyophilized powder containing nominally 200 mg voriconazole and 3,200 mg sulfobutyl ether beta-cyclodextrin sodium in a 30 mL Type I clear glass vial. Voriconazole for injection is intended for administration by intravenous infusion. It is a single-dose, unpreserved product. Vials containing 200 mg lyophilized voriconazole are intended for reconstitution with Water for Injection to produce a solution containing 10 mg/mL voriconazole and 160 mg/mL of sulfobutyl ether beta-cyclodextrin sodium. The resultant solution is further diluted prior to administration as an intravenous infusion [see Dosage and Administration (2) ] . Chemical Structure

Zoledronic Acid ZOLEDRONIC ACID
5 mg Liquid
EUGIA US LLC FDA Rx Only

Zoledronic acid injection contains zoledronic acid, a bisphosphonic acid which is an inhibitor of osteoclastic bone resorption. Zoledronic acid is designated chemically as (1-Hydroxy-2-imidazol-1-yl-phosphonoethyl) phosphonic acid monohydrate and its structural formula is: Zoledronic acid monohydrate is a white to off white crystalline powder. Its molecular formula is C 5 H 10 N 2 O 7 P 2 • H 2 O and a molar mass of 290.1 g/Mol. Zoledronic acid monohydrate is highly soluble in 0.1N sodium hydroxide solution, sparingly soluble in water and 0.1N hydrochloric acid, and practically insoluble in organic solvents. The pH of the zoledronic acid injection solution for infusion is approximately 6.0 to 7.0. Zoledronic acid injection is available as a sterile, clear, colorless solution in bottles for intravenous infusion. One bottle with 100 mL solution contains 5.33 mg zoledronic acid monohydrate, equivalent to 5 mg zoledronic acid on an anhydrous basis. Inactive Ingredients : 4,950 mg of mannitol, USP; 30 mg of sodium citrate; and water for injection q.s. to 100 mL. Zoledronic Acid Monohydrate Chemical Structure

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