Omeprazole and Sodium Bicarbonate

OMEPRAZOLE AND SODIUM BICARBONATE — omeprazole and sodium bicarbonate capsule
Zydus Lifesciences Limited

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
(click image for full-size original)

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
(click image for full-size original)
OMEPRAZOLE AND SODIUM BICARBONATE
omeprazole and sodium bicarbonate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1101
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OMEPRAZOLE (OMEPRAZOLE) OMEPRAZOLE 20 mg
SODIUM BICARBONATE (BICARBONATE ION) SODIUM BICARBONATE 1100 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
GELATIN
SODIUM LAURYL SULFATE
SODIUM STEARYL FUMARATE
TITANIUM DIOXIDE
FERROSOFERRIC OXIDE
BUTYL ALCOHOL
ALCOHOL
ISOPROPYL ALCOHOL
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
WATER
SHELLAC
AMMONIA
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 Multilevel Packaging
1 NDC:70771-1101-7 14 CAPSULE in 1 BOTTLE None
2 NDC:70771-1101-3 30 CAPSULE in 1 BOTTLE None
3 NDC:70771-1101-9 90 CAPSULE in 1 BOTTLE None
4 NDC:70771-1101-1 100 CAPSULE in 1 BOTTLE None
5 NDC:70771-1101-5 500 CAPSULE in 1 BOTTLE None
6 NDC:70771-1101-0 1000 CAPSULE in 1 BOTTLE None
7 NDC:70771-1101-4 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (70771-1101-2)
7 NDC:70771-1101-2 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (70771-1101-4)
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 capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1102
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OMEPRAZOLE (OMEPRAZOLE) OMEPRAZOLE 40 mg
SODIUM BICARBONATE (BICARBONATE ION) SODIUM BICARBONATE 1100 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
GELATIN
SODIUM LAURYL SULFATE
SODIUM STEARYL FUMARATE
TITANIUM DIOXIDE
FERROSOFERRIC OXIDE
BUTYL ALCOHOL
ALCOHOL
ISOPROPYL ALCOHOL
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
WATER
SHELLAC
AMMONIA
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 Multilevel Packaging
1 NDC:70771-1102-3 30 CAPSULE in 1 BOTTLE None
2 NDC:70771-1102-9 90 CAPSULE in 1 BOTTLE None
3 NDC:70771-1102-1 100 CAPSULE in 1 BOTTLE None
4 NDC:70771-1102-5 500 CAPSULE in 1 BOTTLE None
5 NDC:70771-1102-0 1000 CAPSULE in 1 BOTTLE None
6 NDC:70771-1102-4 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (70771-1102-2)
6 NDC:70771-1102-2 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (70771-1102-4)
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 Operations
Zydus Lifesciences Limited 918596198 ANALYSIS (70771-1101), ANALYSIS (70771-1102), MANUFACTURE (70771-1101), MANUFACTURE (70771-1102)

Revised: 10/2022 Zydus Lifesciences Limited

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