Label: RIBAVIRIN capsule

  • NDC Code(s): 65841-260-03, 65841-260-04, 65841-260-07, 65841-260-09, view more
    65841-260-10, 65841-260-12, 65841-260-13, 65841-260-28, 65841-260-30
  • 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.

  • MEDICATION GUIDE

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 65841-260-12 in bottle of 84 capsules

    Ribavirin Capsules USP, 200 mg

    Rx only

    84 capsules

    Ribavirin Capsules, 200 mg
  • INGREDIENTS AND APPEARANCE
    RIBAVIRIN 
    ribavirin capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-260
    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)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    GELATIN (UNII: 2G86QN327L)  
    POVIDONE (UNII: FZ989GH94E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorWHITE (WHITE) Scoreno score
    ShapeCAPSULE (CAPSULE) Size22mm
    FlavorImprint Code ZA;12;200mg
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-260-3010 in 1 CARTON01/25/2006
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:65841-260-0442 in 1 BOTTLE; Type 0: Not a Combination Product01/25/2006
    3NDC:65841-260-0756 in 1 BOTTLE; Type 0: Not a Combination Product01/25/2006
    4NDC:65841-260-0970 in 1 BOTTLE; Type 0: Not a Combination Product01/25/2006
    5NDC:65841-260-1284 in 1 BOTTLE; Type 0: Not a Combination Product01/25/2006
    6NDC:65841-260-13140 in 1 BOTTLE; Type 0: Not a Combination Product01/25/2006
    7NDC:65841-260-03168 in 1 BOTTLE; Type 0: Not a Combination Product01/25/2006
    8NDC:65841-260-28180 in 1 BOTTLE; Type 0: Not a Combination Product01/25/2006
    9NDC:65841-260-101000 in 1 BOTTLE; Type 0: Not a Combination Product01/25/2006
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07722401/25/2006
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198ANALYSIS(65841-260) , MANUFACTURE(65841-260)