Label: AMLODIPINE AND OLMESARTAN MEDOXOMIL tablet, film coated

  • NDC Code(s): 70771-1186-0, 70771-1186-1, 70771-1186-3, 70771-1186-5, view more
    70771-1186-9, 70771-1187-0, 70771-1187-1, 70771-1187-2, 70771-1187-3, 70771-1187-4, 70771-1187-5, 70771-1187-9, 70771-1188-0, 70771-1188-1, 70771-1188-2, 70771-1188-3, 70771-1188-4, 70771-1188-5, 70771-1188-9, 70771-1189-0, 70771-1189-1, 70771-1189-2, 70771-1189-3, 70771-1189-4, 70771-1189-5, 70771-1189-9
  • 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 70771-1186-3

    Amlodipine and olmesartan medoxomil tablets, 5/20 mg

    Rx only

    30 tablets

    Amlodipine and olmesartan medoxomil  tablets

    NDC 70771-1187-3

    Amlodipine and olmesartan medoxomil tablets, 10/20 mg

    Rx only

    30 tablets

    Amlodipine and olmesartan medoxomil  tablets

    NDC 70771-1188-3

    Amlodipine and olmesartan medoxomil tablets, 5/40 mg

    Rx only

    30 tablets

    Amlodipine and olmesartan medoxomil  tablets

    NDC 70771-1189-3

    Amlodipine and olmesartan medoxomil tablets, 10/40 mg

    Rx only

    30 tablets

    Amlodipine and olmesartan medoxomil  tablets
  • INGREDIENTS AND APPEARANCE
    AMLODIPINE AND OLMESARTAN MEDOXOMIL 
    amlodipine and olmesartan medoxomil tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1186
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288) AMLODIPINE5 mg
    OLMESARTAN MEDOXOMIL (UNII: 6M97XTV3HD) (OLMESARTAN - UNII:8W1IQP3U10) OLMESARTAN MEDOXOMIL20 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITE (WHITE) Scoreno score
    ShapeROUND (ROUND) Size7mm
    FlavorImprint Code 927
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1186-330 in 1 BOTTLE; Type 0: Not a Combination Product01/04/2018
    2NDC:70771-1186-990 in 1 BOTTLE; Type 0: Not a Combination Product01/04/2018
    3NDC:70771-1186-1100 in 1 BOTTLE; Type 0: Not a Combination Product01/04/2018
    4NDC:70771-1186-5500 in 1 BOTTLE; Type 0: Not a Combination Product01/04/2018
    5NDC:70771-1186-01000 in 1 BOTTLE; Type 0: Not a Combination Product01/04/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20777101/04/2018
    AMLODIPINE AND OLMESARTAN MEDOXOMIL 
    amlodipine and olmesartan medoxomil tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1187
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288) AMLODIPINE10 mg
    OLMESARTAN MEDOXOMIL (UNII: 6M97XTV3HD) (OLMESARTAN - UNII:8W1IQP3U10) OLMESARTAN MEDOXOMIL20 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorORANGE (ORANGE) Scoreno score
    ShapeROUND (ROUND) Size7mm
    FlavorImprint Code 928
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1187-330 in 1 BOTTLE; Type 0: Not a Combination Product01/04/2018
    2NDC:70771-1187-990 in 1 BOTTLE; Type 0: Not a Combination Product01/04/2018
    3NDC:70771-1187-1100 in 1 BOTTLE; Type 0: Not a Combination Product01/04/2018
    4NDC:70771-1187-5500 in 1 BOTTLE; Type 0: Not a Combination Product01/04/2018
    5NDC:70771-1187-01000 in 1 BOTTLE; Type 0: Not a Combination Product01/04/2018
    6NDC:70771-1187-410 in 1 CARTON01/04/2018
    6NDC:70771-1187-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20777101/04/2018
    AMLODIPINE AND OLMESARTAN MEDOXOMIL 
    amlodipine and olmesartan medoxomil tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1188
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288) AMLODIPINE5 mg
    OLMESARTAN MEDOXOMIL (UNII: 6M97XTV3HD) (OLMESARTAN - UNII:8W1IQP3U10) OLMESARTAN MEDOXOMIL40 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorYELLOW (PALE YELLOW) Scoreno score
    ShapeROUND (ROUND) Size9mm
    FlavorImprint Code 929
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1188-330 in 1 BOTTLE; Type 0: Not a Combination Product01/04/2018
    2NDC:70771-1188-990 in 1 BOTTLE; Type 0: Not a Combination Product01/04/2018
    3NDC:70771-1188-1100 in 1 BOTTLE; Type 0: Not a Combination Product01/04/2018
    4NDC:70771-1188-5500 in 1 BOTTLE; Type 0: Not a Combination Product01/04/2018
    5NDC:70771-1188-01000 in 1 BOTTLE; Type 0: Not a Combination Product01/04/2018
    6NDC:70771-1188-410 in 1 CARTON01/04/2018
    6NDC:70771-1188-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20777101/04/2018
    AMLODIPINE AND OLMESARTAN MEDOXOMIL 
    amlodipine and olmesartan medoxomil tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1189
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288) AMLODIPINE10 mg
    OLMESARTAN MEDOXOMIL (UNII: 6M97XTV3HD) (OLMESARTAN - UNII:8W1IQP3U10) OLMESARTAN MEDOXOMIL40 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorORANGE (ORANGE) Scoreno score
    ShapeROUND (ROUND) Size9mm
    FlavorImprint Code 930
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1189-330 in 1 BOTTLE; Type 0: Not a Combination Product01/04/2018
    2NDC:70771-1189-990 in 1 BOTTLE; Type 0: Not a Combination Product01/04/2018
    3NDC:70771-1189-1100 in 1 BOTTLE; Type 0: Not a Combination Product01/04/2018
    4NDC:70771-1189-5500 in 1 BOTTLE; Type 0: Not a Combination Product01/04/2018
    5NDC:70771-1189-01000 in 1 BOTTLE; Type 0: Not a Combination Product01/04/2018
    6NDC:70771-1189-410 in 1 CARTON01/04/2018
    6NDC:70771-1189-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20777101/04/2018
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited863362789ANALYSIS(70771-1186, 70771-1187, 70771-1188, 70771-1189) , MANUFACTURE(70771-1186, 70771-1187, 70771-1188, 70771-1189)