Label: CISATRACURIUM BESYLATE injection

  • NDC Code(s): 72785-0011-1, 72785-0011-6
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 7, 2020

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  • 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

    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
  • INGREDIENTS AND APPEARANCE
    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)