Cisatracurium Besalayte Injection, USP

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]

CISATRACURIUM BESYLATE- cisatracurium besylate injection 
Zydus Lifesciences Limited

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Cisatracurium Besalayte Injection, USP

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

vial label

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 for 1 vial

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

carton of 10 vials
CISATRACURIUM BESYLATE 
cisatracurium besylate injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 72785-0011
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CISATRACURIUM BESYLATE (UNII: 80YS8O1MBS) (CISATRACURIUM - UNII:QX62KLI41N) CISATRACURIUM2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZENESULFONIC ACID (UNII: 685928Z18A)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 72785-0011-610 in 1 CARTON11/05/202003/25/2025
1NDC: 72785-0011-110 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21352711/05/202005/31/2025
Labeler - Zydus Lifesciences Limited (873671928)
Registrant - Zydus Lifesciences Limited (873671928)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited873671928MANUFACTURE(72785-0011) , ANALYSIS(72785-0011)

Revised: 5/2025
Document Id: 2f5a1479-0707-4b89-b2e0-b61d55ae6503
Set id: ac58faa8-7291-4128-9646-c00be0ce3f81
Version: 3
Effective Time: 20250531