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

Cisatracurium Besylate by

Drug Labeling and Warnings

Cisatracurium Besylate by is a Prescription medication manufactured, distributed, or labeled by Hikma Farmaceutica, Hikma Pharmaceuticals USA Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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
     
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