CISATRACURIUM BESYLATE- cisatracurium besylate injection 
Hikma Farmaceutica

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HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use CISATRACURIUM BESYLATE INJECTION safely and effectively. See full prescribing information for CISATRACURIUM BESYLATE INJECTION.
 CISATRACURIUM BESYLATE injection for intravenous use
Initial U.S. Approval: 1995

ADVERSE REACTIONS

to report suspected adverse reactions (1)

1-800-FDA-1088 (1)

Revised: 2/2024

FULL PRESCRIBING INFORMATION: CONTENTS*

ADVERSE REACTIONS

*
Sections or subsections omitted from the full prescribing information are not listed.

FULL PRESCRIBING INFORMATION

ADVERSE REACTIONS

PRINCIPAL DISPLAY PANEL

 

NDC 0143-9396-01  Rx only

Cisatracurium Besylate Injection, USP

10 mg per 5 mL

(2 mg/mL)

WARNING: Paralyzing Agent

For Intravenous Use

5 mL Single-Dose Vial

Cisatra unit label

NDC 0143-9396-01  Rx only

Cisatracurium Besylate Injection, USP

10 mg per 5 mL

(2 mg/mL)

WARNING: Paralyzing Agent

For Intravenous Use

5 mL Single-Dose Vial x 1

Cisatra carton
CISATRACURIUM BESYLATE 
cisatracurium besylate injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:62778-165
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
WATER (UNII: 059QF0KO0R)  
BENZENESULFINIC ACID (UNII: G9560D97PI)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62778-165-011 in 1 CARTON06/01/202306/01/2023
15 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20307806/01/202306/01/2023
Labeler - Hikma Farmaceutica (452742943)
Registrant - Hikma Pharmaceuticals USA Inc. (001230762)

Revised: 2/2024
Document Id: 2a5216c8-0277-430c-a4de-d058f38a7b46
Set id: 0273051b-fbeb-451c-b240-c524101181f4
Version: 7
Effective Time: 20240209
 
Hikma Farmaceutica