Label: RIBAVIRIN - ribavirin capsule

  • NDC Code(s): 65862-290-39
  • Packager: Aurobindo Pharma Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 24, 2018

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    Ribavirin Capsules

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  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg Bulk Capsule Label



    3000 Capsules 

    Batch      :

    Mfg         :

    Expiry      :

    To be repacked within six months from the date of manufacturing

    NDC 65862-290-39

    BULK SHIPMENT
    PLEASE HANDLE CAREFULLY

    Rx only
      

    Ribavirin Capsules 200 mg


    Each capsule contains:
    Ribavirin USP 200 mg.

    CAUTION:
    FOR REPACKAGING ONLY

    Store at
     20º to 25ºC (68º to 77ºF); excursions permitted to
    15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature].

    Manufactured by:
    Aurobindo Pharma Limited
    Hyderabad-500 072, India

    M.L.No.: 19/HD/AP/95/F/R 



    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg Bulk Capsule Label
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  • INGREDIENTS AND APPEARANCE
    RIBAVIRIN 
    ribavirin capsule
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-290
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    RIBAVIRIN (UNII: 49717AWG6K) (RIBAVIRIN - UNII:49717AWG6K) RIBAVIRIN 200 mg
    Inactive Ingredients
    Ingredient Name Strength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    POVIDONE K30 (UNII: U725QWY32X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    GELATIN (UNII: 2G86QN327L)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Product Characteristics
    Color WHITE Score no score
    Shape CAPSULE Size 19mm
    Flavor Imprint Code E;81
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:65862-290-39 3000 in 1 BAG; Type 0: Not a Combination Product 09/17/2009
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA079117 09/17/2009
    Labeler - Aurobindo Pharma Limited (650082092)
    Establishment
    Name Address ID/FEI Business Operations
    Aurobindo Pharma Limited 918917642 ANALYSIS(65862-290) , MANUFACTURE(65862-290)
    Establishment
    Name Address ID/FEI Business Operations
    Aurobindo Pharma Limited 918917647 API MANUFACTURE(65862-290)
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