CISATRACURIUM BESYLATE injection

cisatracurium besylate by

Drug Labeling and Warnings

cisatracurium besylate by is a Prescription medication manufactured, distributed, or labeled by Zydus Lifesciences Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Container Label (20 mg/10 mL)

NDC: 72758-0011-1

Cisatracurium Besylate Injection, USP

20 mg/10 mL*

(2 mg/mL)

WARNING: Paralyzing Agent

For Intravenous Injection

0.9% benzyl alcohol (added as a preservative)

10 mL Multiple-Dose Vial

Rx only

Carton Label (20 mg/10 mL)

NDC: 72758-0011-1

Cisatracurium Besylate Injection, USP

20 mg/10 mL*

(2 mg/mL)

WARNING: Paralyzing Agent

For Intravenous Injection

0.9% benzyl alcohol (added as a preservative)

10 mL Multiple-Dose Vial

Rx only

Carton Label (20 mg/10 mL)

NDC: 72758-0011-6

Cisatracurium Besylate Injection, USP

20 mg/10 mL*

(2 mg/mL)

WARNING: Paralyzing Agent

For Intravenous Injection

0.9% benzyl alcohol (added as a preservative)

10 x 10 mL Multiple-Dose Vial

Rx only

INGREDIENTS AND APPEARANCE

CISATRACURIUM BESYLATE 
cisatracurium besylate injection

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 72785-0011
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CISATRACURIUM BESYLATE (UNII: 80YS8O1MBS) (CISATRACURIUM - UNII:QX62KLI41N)	CISATRACURIUM	2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZENESULFONIC ACID (UNII: 685928Z18A)
BENZYL ALCOHOL (UNII: LKG8494WBH)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72785-0011-6	10 in 1 CARTON	11/05/2020
1	NDC: 72785-0011-1	10 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA213527	11/05/2020

Labeler - Zydus Lifesciences Limited (873671928)

Registrant - Zydus Lifesciences Limited (873671928)

Establishment
Name	Address	ID/FEI	Business Operations
Zydus Lifesciences Limited		873671928	MANUFACTURE(72785-0011) , ANALYSIS(72785-0011)