Label: ACETAZOLAMIDE injection, powder, lyophilized, for solution

  • NDC Code(s): 70771-1490-1
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 16, 2020

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  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Container Label

    NDC 70771-1490-1

    AcetaZOLAMIDE for Injection USP

    500 mg* per vial

    For Intravenous Use

    1 Single-Dose Vial

    Rx Only

    figure02

    Carton Label

    NDC 70771-1490-1

    AcetaZOLAMIDE for Injection USP

    500 mg* per vial

    For Intravenous Use

    1 Single-Dose Vial

    Rx Only

    figure03
  • INGREDIENTS AND APPEARANCE
    ACETAZOLAMIDE 
    acetazolamide injection, powder, lyophilized, for solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1490
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAZOLAMIDE SODIUM (UNII: 429ZT169UH) (ACETAZOLAMIDE - UNII:O3FX965V0I) ACETAZOLAMIDE500 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1490-11 in 1 CARTON01/09/2020
    15 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20653301/09/2020
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198ANALYSIS(70771-1490) , MANUFACTURE(70771-1490)