CISATRACURIUM BESYLATE- cisatracurium besylate injection 
Cadila Healthcare 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 CARTON11/05/2020
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
ANDAANDA21352711/05/2020
Labeler - Cadila Healthcare Limited (873671928)
Registrant - Cadila Healthcare Limited (873671928)
Establishment
NameAddressID/FEIBusiness Operations
Cadila Healthcare Limited873671928MANUFACTURE(72785-0011) , ANALYSIS(72785-0011)

Revised: 9/2020
Document Id: d5e8ae7e-43a4-41b2-9916-755941da2339
Set id: ac58faa8-7291-4128-9646-c00be0ce3f81
Version: 1
Effective Time: 20200907
 
Cadila Healthcare Limited