Label: RIBAVIRIN tablet, film coated

  • NDC Code(s): 65841-046-03, 65841-046-10, 65841-046-28, 65841-046-77, view more
    65841-129-07, 65841-129-14, 65841-129-17, 65841-603-07, 65841-603-14, 65841-603-17, 65841-632-07, 65841-632-14, 65841-632-17
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 27, 2023

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  • MEDICATION GUIDE

  • SPL MEDGUIDE

  • PRINCIPAL DISPLAY PANEL

    NDC 65841-046-03 in bottle of 168 tablets

    Ribavirin  Tablets , 200 mg

    Rx only

    168 tablets

    Ribavirin tablets, 200 mg

    NDC 65841-603-07 in bottle of 56 tablets

    Ribavirin  Tablets , 400 mg

    Rx only

    56 tablets

    Ribavirin tablet ,400 mg

    NDC 65841-632-07 in bottle of 56 tablets

    Ribavirin  Tablets , 500 mg

    Rx only

    56 tablets

    Ribavirin Tablet 500 mg

    NDC 65841-129-07 in bottle of 56 tablets

    Ribavirin Tablets, 600 mg

    Rx only

    56 tablets

    Ribavirin tablet 600 mg
  • INGREDIENTS AND APPEARANCE
    RIBAVIRIN 
    ribavirin tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-046
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    RIBAVIRIN (UNII: 49717AWG6K) (RIBAVIRIN - UNII:49717AWG6K) RIBAVIRIN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorPINK (LIGHT PINK TO PINK) Scoreno score
    ShapeROUND (ROUND) Size10mm
    FlavorImprint Code ZC19
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-046-03168 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2005
    2NDC:65841-046-28180 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2005
    3NDC:65841-046-101000 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2005
    4NDC:65841-046-7710 in 1 CARTON12/05/2005
    410 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07709412/05/2005
    RIBAVIRIN 
    ribavirin tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-603
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    RIBAVIRIN (UNII: 49717AWG6K) (RIBAVIRIN - UNII:49717AWG6K) RIBAVIRIN400 mg
    Inactive Ingredients
    Ingredient NameStrength
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorPINK (LIGHT PINK TO PINK) Scoreno score
    ShapeOVAL (CAPSULE) Size17mm
    FlavorImprint Code ZD;07
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-603-1728 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2005
    2NDC:65841-603-0756 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2005
    3NDC:65841-603-1460 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2005
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07709412/05/2005
    RIBAVIRIN 
    ribavirin tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-632
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    RIBAVIRIN (UNII: 49717AWG6K) (RIBAVIRIN - UNII:49717AWG6K) RIBAVIRIN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSPOVIDONE (UNII: 2S7830E561)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorPINK (LIGHT PINK TO PINK) Scoreno score
    ShapeOVAL (CAPSULE) Size18mm
    FlavorImprint Code ZC56
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-632-1728 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2005
    2NDC:65841-632-0756 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2005
    3NDC:65841-632-1460 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2005
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07709412/05/2005
    RIBAVIRIN 
    ribavirin tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-129
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    RIBAVIRIN (UNII: 49717AWG6K) (RIBAVIRIN - UNII:49717AWG6K) RIBAVIRIN600 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSPOVIDONE (UNII: 2S7830E561)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorPINK (LIGHT PINK TO PINK) Scoreno score
    ShapeOVAL (CAPSULE) Size21mm
    FlavorImprint Code ZD;08
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-129-1728 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2005
    2NDC:65841-129-0756 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2005
    3NDC:65841-129-1460 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2005
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07709412/05/2005
    Labeler - Zydus Lifesciences Limited (918596198)
    Registrant - Zydus Lifesciences Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited918596198ANALYSIS(65841-046, 65841-603, 65841-632, 65841-129) , MANUFACTURE(65841-046, 65841-603, 65841-632, 65841-129)
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