Label: AMLODIPINE BESYLATE tablet

  • NDC Code(s): 65841-620-01, 65841-620-05, 65841-620-16, 65841-620-77, view more
    65841-621-01, 65841-621-05, 65841-621-16, 65841-621-77, 65841-622-01, 65841-622-05, 65841-622-16, 65841-622-77
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 5, 2020

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 65841-620-16 in bottle of 90 tablets

    Amlodipine Besylate Tablets USP, 2.5 mg

    Rx only

    90 tablets

    Amlodipine Besylate Tablets USP, 2.5 mg

    NDC 65841-621-16 in bottle of 90 tablets

    Amlodipine Besylate Tablets USP, 5 mg

    Rx only

    90 tablets

    Amlodipine Besylate Tablets USP, 5 mg

    NDC 65841-622-16 in bottle of 90 tablets

    Amlodipine Besylate Tablets USP, 10 mg

    Rx only

    90 tablets

    Amlodipine Besylate Tablets USP, 10 mg
  • INGREDIENTS AND APPEARANCE
    AMLODIPINE BESYLATE 
    amlodipine besylate tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-620
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288) AMLODIPINE2.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
    ShapeROUND (ROUND) Size4mm
    FlavorImprint Code Z;7
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-620-1690 in 1 BOTTLE; Type 0: Not a Combination Product09/21/2007
    2NDC:65841-620-01100 in 1 BOTTLE; Type 0: Not a Combination Product09/21/2007
    3NDC:65841-620-05500 in 1 BOTTLE; Type 0: Not a Combination Product09/21/2007
    4NDC:65841-620-7710 in 1 CARTON09/21/2007
    410 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07822609/21/2007
    AMLODIPINE BESYLATE 
    amlodipine besylate tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-621
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288) AMLODIPINE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
    ShapeROUND (ROUND) Size6mm
    FlavorImprint Code Z;3
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-621-1690 in 1 BOTTLE; Type 0: Not a Combination Product09/21/2007
    2NDC:65841-621-01100 in 1 BOTTLE; Type 0: Not a Combination Product09/21/2007
    3NDC:65841-621-05500 in 1 BOTTLE; Type 0: Not a Combination Product09/21/2007
    4NDC:65841-621-7710 in 1 CARTON09/21/2007
    410 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07822609/21/2007
    AMLODIPINE BESYLATE 
    amlodipine besylate tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-622
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288) AMLODIPINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
    ShapeROUND (ROUND) Size8mm
    FlavorImprint Code Z;5
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-622-1690 in 1 BOTTLE; Type 0: Not a Combination Product09/21/2007
    2NDC:65841-622-01100 in 1 BOTTLE; Type 0: Not a Combination Product09/21/2007
    3NDC:65841-622-05500 in 1 BOTTLE; Type 0: Not a Combination Product09/21/2007
    4NDC:65841-622-7710 in 1 CARTON09/21/2007
    410 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07822609/21/2007
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    CADILA HEALTHCARE LIMITED677605858ANALYSIS(65841-620, 65841-621, 65841-622) , MANUFACTURE(65841-620, 65841-621, 65841-622)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198ANALYSIS(65841-620, 65841-621, 65841-622) , MANUFACTURE(65841-620, 65841-621, 65841-622)