Label: AMIODARONE HYDROCHLORIDE tablet

  • NDC Code(s): 65841-631-05, 65841-631-06, 65841-631-10, 65841-631-14, view more
    65841-631-30
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL

Drug Label Information

Updated August 7, 2020

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  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 65841-631-14 in bottle of 60 tablets

    Amiodarone Hydrochloride Tablets, 200 mg

    Rx only

    Amiodarone Hydrochloride Tablets, 200 mg
  • INGREDIENTS AND APPEARANCE
    AMIODARONE HYDROCHLORIDE 
    amiodarone hydrochloride tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-631
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AMIODARONE HYDROCHLORIDE (UNII: 976728SY6Z) (AMIODARONE - UNII:N3RQ532IUT) AMIODARONE HYDROCHLORIDE200 mg
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    POVIDONE (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Score2 pieces
    ShapeROUND (ROUND) Size10mm
    FlavorImprint Code ZE;65
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-631-0630 in 1 BOTTLE; Type 0: Not a Combination Product08/10/2009
    2NDC:65841-631-1460 in 1 BOTTLE; Type 0: Not a Combination Product08/10/2009
    3NDC:65841-631-05500 in 1 BOTTLE; Type 0: Not a Combination Product08/10/2009
    4NDC:65841-631-101000 in 1 BOTTLE; Type 0: Not a Combination Product08/10/2009
    5NDC:65841-631-3010 in 1 CARTON08/10/2009
    510 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07902908/10/2009
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198ANALYSIS(65841-631) , MANUFACTURE(65841-631)