Label: ETOMIDATE injection, solution

  • NDC Code(s): 65841-818-07, 65841-818-08
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL

Drug Label Information

Updated July 28, 2020

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  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Vial Label 10 mL

    Zydus Pharmaceuticals

    NDC 65841-818-07

    Etomidate Injection, USP

    20 mg/10 mL

    (2 mg/mL)

    For Intravenous Use

    10 mL, Single-Dose Vial

    Rx Only

    figure02

    Carton Label 10 mL

    Zydus Pharmaceuticals

    NDC 65841-818-07

    Etomidate injection, USP

    20 mg/10 mL

    (2 mg/mL)

    For Intravenous Use

    10 x 10 mL, Single-Dose Vials

    Rx Only

    figure03

    Vial Label 20 mL

    Zydus Pharmaceuticals

    NDC 65841-818-08

    Etomidate injection, USP

    40 mg/20 mL

    (2 mg/mL)

    For Intravenous Use

    20 mL, Single-Dose Vial

    Rx Only

    figure04

    Carton Label 20 mL

    Zydus Pharmaceuticals

    NDC 65841-818-08

    Etomidate injection, USP

    40 mg/20 mL

    (2 mg/mL)

    For Intravenous Use

    10 x 20 mL, Single-Dose Vials

    Rx Only

    figure05
  • INGREDIENTS AND APPEARANCE
    ETOMIDATE 
    etomidate injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-818
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ETOMIDATE (UNII: Z22628B598) (ETOMIDATE - UNII:Z22628B598) ETOMIDATE2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.35 mL  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-818-0710 in 1 TRAY04/03/2015
    110 mL in 1 VIAL; Type 0: Not a Combination Product
    2NDC:65841-818-0810 in 1 TRAY04/03/2015
    220 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20236004/03/2015
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198MANUFACTURE(65841-818) , ANALYSIS(65841-818)