Label: VALACYCLOVIR tablet, film coated

  • NDC Code(s): 65841-629-01, 65841-629-06, 65841-629-10, 65841-629-30, view more
    65841-629-77, 65841-630-06, 65841-630-10, 65841-630-34
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 14, 2020

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

  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 65841-629-06 in bottle of 30 tablets

    Valacyclovir Tablets USP, 500 mg

    Rx only

    30 tablets

    Valacyclovir tablets

    NDC 65841-630-06 in bottle of 30 tablets

    Valacyclovir Tablets USP, 1 gram

    Rx only

    30 tablets

    Valacyclovir tablets
  • INGREDIENTS AND APPEARANCE
    VALACYCLOVIR 
    valacyclovir tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-629
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VALACYCLOVIR HYDROCHLORIDE (UNII: G447S0T1VC) (ACYCLOVIR - UNII:X4HES1O11F) VALACYCLOVIR500 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSPOVIDONE (UNII: 2S7830E561)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POVIDONE (UNII: FZ989GH94E)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorWHITE (WHITE) Scoreno score
    ShapeOVAL (CAPSULE) Size18mm
    FlavorImprint Code 500
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-629-0630 in 1 BOTTLE; Type 0: Not a Combination Product04/05/2018
    2NDC:65841-629-01100 in 1 BOTTLE; Type 0: Not a Combination Product04/05/2018
    3NDC:65841-629-101000 in 1 BOTTLE; Type 0: Not a Combination Product04/05/2018
    4NDC:65841-629-7710 in 1 CARTON04/05/2018
    4NDC:65841-629-3010 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07913704/05/2018
    VALACYCLOVIR 
    valacyclovir tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-630
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VALACYCLOVIR HYDROCHLORIDE (UNII: G447S0T1VC) (ACYCLOVIR - UNII:X4HES1O11F) VALACYCLOVIR1000 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSPOVIDONE (UNII: 2S7830E561)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POVIDONE (UNII: FZ989GH94E)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorWHITE (WHITE) Score2 pieces
    ShapeOVAL (CAPSULE) Size23mm
    FlavorImprint Code 1000
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-630-3421 in 1 BOTTLE; Type 0: Not a Combination Product04/05/2018
    2NDC:65841-630-101000 in 1 BOTTLE; Type 0: Not a Combination Product04/05/2018
    3NDC:65841-630-0630 in 1 BOTTLE; Type 0: Not a Combination Product04/05/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07913704/05/2018
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198ANALYSIS(65841-629, 65841-630) , MANUFACTURE(65841-629, 65841-630)