Label: AMIODARONE HYDROCHLORIDE tablet

  • NDC Code(s): 65841-631-05, 65841-631-06, 65841-631-10, 65841-631-14, view more
    65841-631-77, 65841-840-06, 65841-841-06
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 27, 2023

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  • MEDICATION GUIDE

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 65841-840-06

    Amiodarone Hydrochloride Tablets USP, 100 mg

    30 Tablets

    Rx only

    100 mg label

    NDC 65841-631-14 in bottle of 60 tablets

    Amiodarone Hydrochloride Tablets, 200 mg

    Rx only

    Amiodarone Hydrochloride Tablets, 200 mg

    NDC 65841-841-06

    Amiodarone Hydrochloride Tablets USP, 400 mg

    30 Tablets

    Rx only

    400 mg label
  • INGREDIENTS AND APPEARANCE
    AMIODARONE HYDROCHLORIDE 
    amiodarone hydrochloride tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-840
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AMIODARONE HYDROCHLORIDE (UNII: 976728SY6Z) (AMIODARONE - UNII:N3RQ532IUT) AMIODARONE HYDROCHLORIDE100 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 (OFF-WHITE) Scoreno score
    ShapeROUND (ROUND) Size8mm
    FlavorImprint Code 297
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-840-0630 in 1 BOTTLE; Type 0: Not a Combination Product02/09/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07902902/09/2023
    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:65841-631-7710 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
    AMIODARONE HYDROCHLORIDE 
    amiodarone hydrochloride tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-841
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AMIODARONE HYDROCHLORIDE (UNII: 976728SY6Z) (AMIODARONE - UNII:N3RQ532IUT) AMIODARONE HYDROCHLORIDE400 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)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE (UNII: FZ989GH94E)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Product Characteristics
    ColorYELLOW (PALE YELLOW TO YELLOW) Score2 pieces
    ShapeROUND (ROUND) Size13mm
    FlavorImprint Code 2;98
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-841-0630 in 1 BOTTLE; Type 0: Not a Combination Product02/09/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07902902/09/2023
    Labeler - Zydus Lifesciences Limited (918596198)
    Registrant - Zydus Lifesciences Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited918596198ANALYSIS(65841-631, 65841-840, 65841-841) , MANUFACTURE(65841-631, 65841-840, 65841-841)
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