Label: ACYCLOVIR injection, powder, lyophilized, for solution

  • NDC Code(s): 70771-1081-6, 70771-1082-6
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 12, 2020

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  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL - PRINCIPAL DISPLAY PANEL

    Acyclovir for Injection, USP 500 mg/vial - Vial Label

    NDC 70771-1081-1

    Acyclovir for Injection, USP

    Equivalent to

    500 mg/vial

    acyclovir

    For Intravenous Infusion Only

    Rx only

    zydus pharmaceuticals

    Acyclovir sodium Injection, 500 mg/vial

    Acyclovir for Injection, USP 500 mg/vial - Carton Label

    NDC 70771-1081-6

    Acyclovir for Injection, USP

    Equivalent to

    500 mg/vial

    acyclovir

    For Intravenous Infusion Only

    10 x 500 mg vials

    Rx only

    zydus pharmaceuticals

    Acyclovir for Injection USP, 500 mg/Vial

    Acyclovir for Injection, USP 1000 mg/vial - Vial Label

    NDC 70771-1082-1

    Acyclovir for Injection, USP

    Equivalent to

    1000 mg/vial

    acyclovir

    For Intravenous Infusion Only

    Rx only

    zydus pharmaceuticals

    Acyclovir for Injection USP, 1000 mg/vial


Vial Label

Rx Only

							Acyclovir sodium Injection, 50 mg/mL

    Acyclovir for Injection, USP 1000 mg/vial - Carton Label

    NDC 70771-1082-6

    Acyclovir for Injection, USP

    Equivalent to

    1000 mg/vial

    acyclovir

    For Intravenous Infusion Only

    10 x 1000 mg vials

    Rx only

    zydus pharmaceuticals

    Acyclovir for Injection USP, 1000 mg/vial
  • INGREDIENTS AND APPEARANCE
    ACYCLOVIR 
    acyclovir injection, powder, lyophilized, for solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1081
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACYCLOVIR SODIUM (UNII: 927L42J563) (ACYCLOVIR - UNII:X4HES1O11F) ACYCLOVIR500 mg
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1081-610 in 1 CARTON; Type 0: Not a Combination Product08/17/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20660608/17/2017
    ACYCLOVIR 
    acyclovir injection, powder, lyophilized, for solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1082
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACYCLOVIR SODIUM (UNII: 927L42J563) (ACYCLOVIR - UNII:X4HES1O11F) ACYCLOVIR1000 mg
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1082-610 in 1 CARTON; Type 0: Not a Combination Product08/17/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20660608/17/2017
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198ANALYSIS(70771-1081, 70771-1082) , MANUFACTURE(70771-1081, 70771-1082)