Label: ACYCLOVIR injection, solution

  • NDC Code(s): 70771-1383-1, 70771-1383-6, 70771-1384-1, 70771-1384-6
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 11, 2020

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    PACKAGE LABEL - PRINCIPAL DISPLAY - 10 mL Single-Use Container Label

    NDC 70771-1383-1

    Acyclovir Sodium Injection

    500 mg/10 mL*

    (50 mg/mL)

    For Intravenous Infusion Only

    MUST BE DILUTED PRIOR TO USE

    10 mL Single-Use Vial

    Rx only

    zydus pharmaceuticals

     

    figure02

    PACKAGE LABEL - PRINCIPAL DISPLAY - 10 mL Single-Use Carton Label

    NDC 70771-1383-6

    Acyclovir Sodium Injection

    500 mg/10 mL*

    (50 mg/mL)

    For Intravenous Infusion Only

    MUST BE DILUTED PRIOR TO USE

    10 x 10 mL Single-Use Vial

    Rx only

    zydus pharmaceuticals

    figure03

    PACKAGE LABEL - PRINCIPAL DISPLAY - 20 mL Single-Use Container Label

    NDC 70771-1384-1

    Acyclovir Sodium Injection

    1000 mg/20 mL*

    (50 mg/mL)

    For Intravenous Infusion Only

    MUST BE DILUTED PRIOR TO USE

    20 mL Single-Use Vial

    Rx only

    zydus pharmaceuticals

     

    figure04

    PACKAGE LABEL - PRINCIPAL DISPLAY - 20 mL Single-Use Carton Label

    NDC 70771-1384-6

    Acyclovir Sodium Injection

    1000 mg/20 mL*

    (50 mg/mL)

    For Intravenous Infusion Only

    MUST BE DILUTED PRIOR TO USE

    10 x 20 mL Single-Use Vial

    Rx only

    zydus pharmaceuticals

    figure05
  • INGREDIENTS AND APPEARANCE
    ACYCLOVIR 
    acyclovir injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1383
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACYCLOVIR SODIUM (UNII: 927L42J563) (ACYCLOVIR - UNII:X4HES1O11F) ACYCLOVIR50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1383-610 in 1 CARTON11/27/2018
    1NDC:70771-1383-110 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20653511/27/2018
    ACYCLOVIR 
    acyclovir injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1384
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACYCLOVIR SODIUM (UNII: 927L42J563) (ACYCLOVIR - UNII:X4HES1O11F) ACYCLOVIR50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1384-610 in 1 CARTON11/27/2018
    1NDC:70771-1384-120 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20653511/27/2018
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198ANALYSIS(70771-1383, 70771-1384) , MANUFACTURE(70771-1383, 70771-1384)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited873671928MANUFACTURE(70771-1383, 70771-1384) , ANALYSIS(70771-1383, 70771-1384)