Label: OMEPRAZOLE AND SODIUM BICARBONATE capsule
-
NDC Code(s):
70771-1101-0,
70771-1101-1,
70771-1101-2,
70771-1101-3, view more70771-1101-4, 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: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated September 27, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Medication Guide: HTML
- Official Label (Printer Friendly)
- MEDICATION GUIDE
- SPL MEDGUIDE
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
OMEPRAZOLE AND SODIUM BICARBONATE
omeprazole and sodium bicarbonate capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1101 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE 20 mg SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE 1100 mg Inactive Ingredients Ingredient Name Strength 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 Color WHITE (OPAQUE WHITE) , WHITE (OPAQUE WHITE) Score no score Shape CAPSULE (CAPSULE) Size 23mm Flavor Imprint Code 501 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1101-7 14 in 1 BOTTLE; Type 0: Not a Combination Product 05/29/2018 2 NDC:70771-1101-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 05/29/2018 3 NDC:70771-1101-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 05/29/2018 4 NDC:70771-1101-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/29/2018 5 NDC:70771-1101-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 05/29/2018 6 NDC:70771-1101-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 05/29/2018 7 NDC:70771-1101-4 10 in 1 CARTON 05/29/2018 7 NDC:70771-1101-2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA203290 05/29/2018 OMEPRAZOLE AND SODIUM BICARBONATE
omeprazole and sodium bicarbonate capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1102 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9) OMEPRAZOLE 40 mg SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE 1100 mg Inactive Ingredients Ingredient Name Strength 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 Color WHITE (OPAQUE WHITE) , WHITE (OPAQUE WHITE) Score no score Shape CAPSULE (CAPSULE) Size 23mm Flavor Imprint Code 502 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1102-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 05/29/2018 2 NDC:70771-1102-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 05/29/2018 3 NDC:70771-1102-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/29/2018 4 NDC:70771-1102-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 05/29/2018 5 NDC:70771-1102-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 05/29/2018 6 NDC:70771-1102-4 10 in 1 CARTON 05/29/2018 6 NDC:70771-1102-2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA203290 05/29/2018 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(70771-1101, 70771-1102) , MANUFACTURE(70771-1101, 70771-1102)