Label: CISATRACURIUM BESYLATE injection

  • NDC Code(s): 72785-0008-1, 72785-0008-6, 72785-0009-1, 72785-0009-6
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL

Drug Label Information

Updated October 12, 2020

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  • SPL UNCLASSIFIED SECTION

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel – Container Label (10 mg/5 mL)

    NDC 72785-0008-1

    Cisatracurium Besylate Injection, USP

    10 mg/5 mL*

    (2 mg/mL)

    WARNING: Paralyzing Agent

    For Intravenous Injection

    Preservative free

    5 mL Single-Dose Vial

    Rx only

    Zydus Pharmaceuticals

    image10

    Principal Display Panel – Container Label (200 mg/20 mL)

    NDC 72785-0009-1

    Cisatracurium Besylate Injection, USP

    200 mg/20 mL*

    (10 mg/mL)

    WARNING: Paralyzing Agent

    For ICU use only.

    For Intravenous Injection

    Preservative free

    20 mL Single-Dose Vial

    Rx only

    Zydus Pharmaceuticals

    image11

    Principal Display Panel – Carton Label (10 mg/5 mL)

    NDC 72785-0008-6

    Cisatracurium Besylate Injection, USP

    10 mg/5 mL*

    (2 mg/mL)

    WARNING: Paralyzing Agent

    For Intravenous Injection

    Preservative free

    10 x 5 mL Single-Dose Vials

    Rx only

    Zydus Pharmaceuticals

    image12

    Principal Display Panel – Carton Label (200 mg/20 mL)

    NDC 72785-0009-6

    Cisatracurium Besylate Injection, USP

    200 mg/20 mL*

    (10 mg/mL)

    WARNING: Paralyzing Agent

    For ICU use only.

    For Intravenous Injection

    Preservative free

    10 x 20 mL Single-Dose Vials

    Rx only

    Zydus Pharmaceuticals

    image13
  • INGREDIENTS AND APPEARANCE
    CISATRACURIUM BESYLATE 
    cisatracurium besylate injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72785-0008
    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)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72785-0008-610 in 1 CARTON02/12/2020
    1NDC:72785-0008-15 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21217102/12/2020
    CISATRACURIUM BESYLATE 
    cisatracurium besylate injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72785-0009
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CISATRACURIUM BESYLATE (UNII: 80YS8O1MBS) (CISATRACURIUM - UNII:QX62KLI41N) CISATRACURIUM10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZENESULFONIC ACID (UNII: 685928Z18A)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72785-0009-610 in 1 CARTON02/12/2020
    1NDC:72785-0009-120 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21217102/12/2020
    Labeler - Cadila Healthcare Limited (873671928)