Label: LANSOPRAZOLE capsule, delayed release pellets

  • NDC Code(s): 65841-769-06, 65841-769-10, 65841-769-30, 65841-770-01, view more
    65841-770-06, 65841-770-10, 65841-770-16, 65841-770-30
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 31, 2020

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

  • MEDICATION GUIDE

    Manufactured by:

    Cadila Healthcare Ltd.

    India.

  • PRINCIPAL DISPLAY PANEL

    NDC 65841-769-10 in bottle of 1000 Capsules

    Lansoprazole Delayed-release Capsules USP, 15 mg

    Rx only

    1000 Capsules

    Structured formula for lansoprazole

    NDC 65841-770-10 in bottle of 1000 Capsules

    Lansoprazole Delayed-release Capsules USP, 30 mg

    Rx only

    1000 Capsules

    Structured formula for lansoprazole
  • INGREDIENTS AND APPEARANCE
    LANSOPRAZOLE 
    lansoprazole capsule, delayed release pellets
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-769
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LANSOPRAZOLE (UNII: 0K5C5T2QPG) (LANSOPRAZOLE - UNII:0K5C5T2QPG) LANSOPRAZOLE15 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    AMMONIA (UNII: 5138Q19F1X)  
    BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    SHELLAC (UNII: 46N107B71O)  
    MAGNESIUM CARBONATE (UNII: 0E53J927NA)  
    METHACRYLIC ACID (UNII: 1CS02G8656)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    GELATIN (UNII: 2G86QN327L)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorPINK (PINK) , WHITE (WHITE) Scoreno score
    ShapeCAPSULE (CAPSULE) Size16mm
    FlavorImprint Code ZA;50;15mg
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-769-0630 in 1 BOTTLE; Type 0: Not a Combination Product08/23/2013
    2NDC:65841-769-101000 in 1 BOTTLE; Type 0: Not a Combination Product08/23/2013
    3NDC:65841-769-3010 in 1 CARTON08/23/2013
    310 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20236608/23/2013
    LANSOPRAZOLE 
    lansoprazole capsule, delayed release pellets
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-770
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LANSOPRAZOLE (UNII: 0K5C5T2QPG) (LANSOPRAZOLE - UNII:0K5C5T2QPG) LANSOPRAZOLE30 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    AMMONIA (UNII: 5138Q19F1X)  
    BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    SHELLAC (UNII: 46N107B71O)  
    MAGNESIUM CARBONATE (UNII: 0E53J927NA)  
    METHACRYLIC ACID (UNII: 1CS02G8656)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    GELATIN (UNII: 2G86QN327L)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorPINK (PINK) , WHITE (WHITE) Scoreno score
    ShapeCAPSULE (CAPSULE) Size20mm
    FlavorImprint Code ZA;51;30mg
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-770-0630 in 1 BOTTLE; Type 0: Not a Combination Product08/23/2013
    2NDC:65841-770-1690 in 1 BOTTLE; Type 0: Not a Combination Product08/23/2013
    3NDC:65841-770-01100 in 1 BOTTLE; Type 0: Not a Combination Product08/23/2013
    4NDC:65841-770-101000 in 1 BOTTLE; Type 0: Not a Combination Product08/23/2013
    5NDC:65841-770-3010 in 1 CARTON08/23/2013
    510 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20236608/23/2013
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198ANALYSIS(65841-769, 65841-770) , MANUFACTURE(65841-769, 65841-770)