Label: RAMIPRIL capsule

  • NDC Code(s): 65841-655-01, 65841-655-05, 65841-655-06, 65841-655-16, view more
    65841-655-30, 65841-656-01, 65841-656-05, 65841-656-06, 65841-656-16, 65841-656-30, 65841-657-01, 65841-657-05, 65841-657-06, 65841-657-16, 65841-657-30, 65841-658-01, 65841-658-05, 65841-658-06, 65841-658-16, 65841-658-30
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 31, 2022

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  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 65841-655-06 in bottle of 30 Capsules

    Ramipril Capsules, 1.25 mg

    Rx only

    30 Capsules

    Ramipril Capsules, 1.25 mg

    NDC 65841-656-01 in bottle of 100 Capsules

    Ramipril Capsules, 2.5 mg

    Rx only

    100 Capsules

    Ramipril Capsules, 2.5 mg

    NDC 65841-657-01 in bottle of 100 Capsules

    Ramipril Capsules, 5 mg

    Rx only

    100 Capsules

    Ramipril Capsules, 5 mg

    NDC 65841-658-01 in bottle of 100 Capsules

    Ramipril Capsules, 10 mg

    Rx only

    100 Capsules

    Ramipril Capsules, 10 mg
  • INGREDIENTS AND APPEARANCE
    RAMIPRIL 
    ramipril capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-655
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    RAMIPRIL (UNII: L35JN3I7SJ) (RAMIPRILAT - UNII:6N5U4QFC3G) RAMIPRIL1.25 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Product Characteristics
    ColorWHITE (WHITE) , YELLOW (YELLOW) Scoreno score
    ShapeCAPSULE (CAPSULE) Size14mm
    FlavorImprint Code ZA;43;1;25mg
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-655-0630 in 1 BOTTLE; Type 0: Not a Combination Product11/20/2010
    2NDC:65841-655-1690 in 1 BOTTLE; Type 0: Not a Combination Product11/20/2010
    3NDC:65841-655-01100 in 1 BOTTLE; Type 0: Not a Combination Product11/20/2010
    4NDC:65841-655-05500 in 1 BOTTLE; Type 0: Not a Combination Product11/20/2010
    5NDC:65841-655-3010 in 1 CARTON11/20/2010
    510 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07883211/20/2010
    RAMIPRIL 
    ramipril capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-656
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    RAMIPRIL (UNII: L35JN3I7SJ) (RAMIPRILAT - UNII:6N5U4QFC3G) RAMIPRIL2.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Product Characteristics
    ColorWHITE (WHITE) , ORANGE (ORANGE) Scoreno score
    ShapeCAPSULE (CAPSULE) Size14mm
    FlavorImprint Code ZA;44;2;5mg
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-656-0630 in 1 BOTTLE; Type 0: Not a Combination Product11/20/2010
    2NDC:65841-656-1690 in 1 BOTTLE; Type 0: Not a Combination Product11/20/2010
    3NDC:65841-656-01100 in 1 BOTTLE; Type 0: Not a Combination Product11/20/2010
    4NDC:65841-656-05500 in 1 BOTTLE; Type 0: Not a Combination Product11/20/2010
    5NDC:65841-656-3010 in 1 CARTON11/20/2010
    510 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07883211/20/2010
    RAMIPRIL 
    ramipril capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-657
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    RAMIPRIL (UNII: L35JN3I7SJ) (RAMIPRILAT - UNII:6N5U4QFC3G) RAMIPRIL5 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Product Characteristics
    ColorWHITE (WHITE) , RED (RED) Scoreno score
    ShapeCAPSULE (CAPSULE) Size14mm
    FlavorImprint Code ZA;45;5mg
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-657-0630 in 1 BOTTLE; Type 0: Not a Combination Product11/20/2010
    2NDC:65841-657-1690 in 1 BOTTLE; Type 0: Not a Combination Product11/20/2010
    3NDC:65841-657-01100 in 1 BOTTLE; Type 0: Not a Combination Product11/20/2010
    4NDC:65841-657-05500 in 1 BOTTLE; Type 0: Not a Combination Product11/20/2010
    5NDC:65841-657-3010 in 1 CARTON11/20/2010
    510 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07883211/20/2010
    RAMIPRIL 
    ramipril capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-658
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    RAMIPRIL (UNII: L35JN3I7SJ) (RAMIPRILAT - UNII:6N5U4QFC3G) RAMIPRIL10 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Product Characteristics
    ColorWHITE (WHITE) , BLUE (BLUE) Scoreno score
    ShapeCAPSULE (CAPSULE) Size14mm
    FlavorImprint Code ZA;46;10mg
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-658-0630 in 1 BOTTLE; Type 0: Not a Combination Product11/20/2010
    2NDC:65841-658-1690 in 1 BOTTLE; Type 0: Not a Combination Product11/20/2010
    3NDC:65841-658-01100 in 1 BOTTLE; Type 0: Not a Combination Product11/20/2010
    4NDC:65841-658-05500 in 1 BOTTLE; Type 0: Not a Combination Product11/20/2010
    5NDC:65841-658-3010 in 1 CARTON11/20/2010
    510 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07883211/20/2010
    Labeler - Zydus Lifesciences Limited (918596198)
    Registrant - Zydus Lifesciences Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited918596198ANALYSIS(65841-655, 65841-656, 65841-657, 65841-658) , MANUFACTURE(65841-655, 65841-656, 65841-657, 65841-658)
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