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FDA Drug information

Omeprazole and sodium bicarbonate

Read time: 1 mins
Marketing start date: 29 Apr 2024
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Summary of product characteristics


Effective Time

20230927

Version

6

Spl Product Data Elements

omeprazole and sodium bicarbonate omeprazole and sodium bicarbonate OMEPRAZOLE OMEPRAZOLE SODIUM BICARBONATE BICARBONATE ION 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 OPAQUE WHITE OPAQUE WHITE CAPSULE 501 omeprazole and sodium bicarbonate omeprazole and sodium bicarbonate OMEPRAZOLE OMEPRAZOLE SODIUM BICARBONATE BICARBONATE ION 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 OPAQUE WHITE OPAQUE WHITE CAPSULE 502

Application Number

ANDA203290

Brand Name

Omeprazole and sodium bicarbonate

Generic Name

omeprazole and sodium bicarbonate

Product Ndc

70771-1101

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1101-3 in bottle of 30 capsules Omeprazole and Sodium Bicarbonate Capsules, 20 mg/1100 mg R x only 30 capsules ZYDUS NDC 70771-1102-3 in bottle of 30 capsules Omeprazole and Sodium Bicarbonate Capsules, 40 mg/1100 mg R x only 30 capsules ZYDUS Omeprazole capsules omeprazole capsules02

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