Label: OMEPRAZOLE AND SODIUM BICARBONATE capsule

  • NDC Code(s): 70771-1101-0, 70771-1101-1, 70771-1101-2, 70771-1101-3, view more
    70771-1101-4, 70771-1101-5, 70771-1101-7, 70771-1101-9, 70771-1102-0, 70771-1102-1, 70771-1102-2, 70771-1102-3, 70771-1102-4, 70771-1102-5, 70771-1102-9
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 8, 2020

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

  • MEDICATION GUIDE

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1101-3 in bottle of 30 capsules

     

    Omeprazole and Sodium Bicarbonate Capsules, 20 mg/1100 mg

     

    Rx only

     

    30 capsules

     

    ZYDUS

    Omeprazole capsules

    NDC 70771-1102-3 in bottle of 30 capsules

     

    Omeprazole and Sodium Bicarbonate Capsules, 40 mg/1100 mg

     

    Rx only

     

    30 capsules

     

    ZYDUS

    omeprazole capsules02
  • INGREDIENTS AND APPEARANCE
    OMEPRAZOLE AND SODIUM BICARBONATE 
    omeprazole and sodium bicarbonate capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1101
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE20 mg
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE1100 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    GELATIN (UNII: 2G86QN327L)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
    ALCOHOL (UNII: 3K9958V90M)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SHELLAC (UNII: 46N107B71O)  
    AMMONIA (UNII: 5138Q19F1X)  
    Product Characteristics
    ColorWHITE (OPAQUE WHITE) , WHITE (OPAQUE WHITE) Scoreno score
    ShapeCAPSULE (CAPSULE) Size23mm
    FlavorImprint Code 501
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1101-714 in 1 BOTTLE; Type 0: Not a Combination Product05/29/2018
    2NDC:70771-1101-330 in 1 BOTTLE; Type 0: Not a Combination Product05/29/2018
    3NDC:70771-1101-990 in 1 BOTTLE; Type 0: Not a Combination Product05/29/2018
    4NDC:70771-1101-1100 in 1 BOTTLE; Type 0: Not a Combination Product05/29/2018
    5NDC:70771-1101-5500 in 1 BOTTLE; Type 0: Not a Combination Product05/29/2018
    6NDC:70771-1101-01000 in 1 BOTTLE; Type 0: Not a Combination Product05/29/2018
    7NDC:70771-1101-410 in 1 CARTON05/29/2018
    7NDC:70771-1101-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20329005/29/2018
    OMEPRAZOLE AND SODIUM BICARBONATE 
    omeprazole and sodium bicarbonate capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1102
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE40 mg
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE1100 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    GELATIN (UNII: 2G86QN327L)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
    ALCOHOL (UNII: 3K9958V90M)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SHELLAC (UNII: 46N107B71O)  
    AMMONIA (UNII: 5138Q19F1X)  
    Product Characteristics
    ColorWHITE (OPAQUE WHITE) , WHITE (OPAQUE WHITE) Scoreno score
    ShapeCAPSULE (CAPSULE) Size23mm
    FlavorImprint Code 502
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1102-330 in 1 BOTTLE; Type 0: Not a Combination Product05/29/2018
    2NDC:70771-1102-990 in 1 BOTTLE; Type 0: Not a Combination Product05/29/2018
    3NDC:70771-1102-1100 in 1 BOTTLE; Type 0: Not a Combination Product05/29/2018
    4NDC:70771-1102-5500 in 1 BOTTLE; Type 0: Not a Combination Product05/29/2018
    5NDC:70771-1102-01000 in 1 BOTTLE; Type 0: Not a Combination Product05/29/2018
    6NDC:70771-1102-410 in 1 CARTON05/29/2018
    6NDC:70771-1102-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20329005/29/2018
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198ANALYSIS(70771-1101, 70771-1102) , MANUFACTURE(70771-1101, 70771-1102)