Label: RAMIPRIL tablet

  • NDC Code(s): 65841-699-01, 65841-699-05, 65841-699-06, 65841-699-10, view more
    65841-699-16, 65841-699-77, 65841-700-01, 65841-700-05, 65841-700-06, 65841-700-10, 65841-700-16, 65841-700-77, 65841-701-01, 65841-701-05, 65841-701-06, 65841-701-10, 65841-701-16, 65841-701-77, 65841-702-01, 65841-702-05, 65841-702-06, 65841-702-10, 65841-702-16, 65841-702-77
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 14, 2022

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  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 65841-699-05 in bottle of 500 tablets

    Ramipril Tablets, 1.25 mg

    Rx only

    500 tablets

    Ramipril Tablets, 1.25 mg

    NDC 65841-700-05 in bottle of 500 tablets

    Ramipril Tablets, 2.5 mg

    Rx only

    500 tablets

    Ramipril Tablets, 2.5 mg

    NDC 65841-701-05 in bottle of 500 tablets

    Ramipril Tablets, 5 mg

    Rx only

    500 tablets

    Ramipril Tablets, 5 mg

    NDC 65841-702- 05 in bottle of 500 tablets

    Ramipril Tablets, 10 mg

    Rx only

    500 tablets

    Ramipril Tablets, 10 mg
  • INGREDIENTS AND APPEARANCE
    RAMIPRIL 
    ramipril tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-699
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    RAMIPRIL (UNII: L35JN3I7SJ) (RAMIPRILAT - UNII:6N5U4QFC3G) RAMIPRIL1.25 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
    Product Characteristics
    ColorYELLOW (YELLOW) Scoreno score
    ShapeCAPSULE (CAPSULE) Size8mm
    FlavorImprint Code 374
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-699-0630 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
    2NDC:65841-699-1690 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
    3NDC:65841-699-01100 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
    4NDC:65841-699-05500 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
    5NDC:65841-699-101000 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
    6NDC:65841-699-7710 in 1 CARTON12/05/2017
    610 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09069712/05/2017
    RAMIPRIL 
    ramipril tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-700
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    RAMIPRIL (UNII: L35JN3I7SJ) (RAMIPRILAT - UNII:6N5U4QFC3G) RAMIPRIL2.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
    Product Characteristics
    ColorORANGE (PEACH) Scoreno score
    ShapeCAPSULE (CAPSULE) Size8mm
    FlavorImprint Code 375
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-700-0630 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
    2NDC:65841-700-1690 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
    3NDC:65841-700-01100 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
    4NDC:65841-700-05500 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
    5NDC:65841-700-101000 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
    6NDC:65841-700-7710 in 1 CARTON12/05/2017
    610 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09069712/05/2017
    RAMIPRIL 
    ramipril tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-701
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    RAMIPRIL (UNII: L35JN3I7SJ) (RAMIPRILAT - UNII:6N5U4QFC3G) RAMIPRIL5 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
    Product Characteristics
    ColorRED (PINK TO RED) Scoreno score
    ShapeCAPSULE (CAPSULE) Size8mm
    FlavorImprint Code 376
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-701-0630 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
    2NDC:65841-701-1690 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
    3NDC:65841-701-01100 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
    4NDC:65841-701-05500 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
    5NDC:65841-701-101000 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
    6NDC:65841-701-7710 in 1 CARTON12/05/2017
    610 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09069712/05/2017
    RAMIPRIL 
    ramipril tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-702
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    RAMIPRIL (UNII: L35JN3I7SJ) (RAMIPRILAT - UNII:6N5U4QFC3G) RAMIPRIL10 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
    ShapeCAPSULE (CAPSULE) Size8mm
    FlavorImprint Code 377
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-702-0630 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
    2NDC:65841-702-1690 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
    3NDC:65841-702-01100 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
    4NDC:65841-702-05500 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
    5NDC:65841-702-101000 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
    6NDC:65841-702-7710 in 1 CARTON12/05/2017
    610 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09069712/05/2017
    Labeler - Zydus Lifesciences Limited (918596198)
    Registrant - Zydus Lifesciences Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited918596198ANALYSIS(65841-699, 65841-700, 65841-701, 65841-702) , MANUFACTURE(65841-699, 65841-700, 65841-701, 65841-702)
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