omeprazole sodium bicarbonate (69097-913)

Drug Facts

Product Profile

Brand Name omeprazole sodium bicarbonate

Generic Name omeprazole sodium bicarbonate

Labeler cipla usa inc.

Dosage Form CAPSULE

Routes

ORAL

Active Ingredients

omeprazole 20 mg/1, sodium bicarbonate 1100 mg/1

Manufacturer

Cipla USA Inc.

Identifiers & Regulatory

Product NDC 69097-913

Product ID 69097-913_d7eae0fc-9dfd-48d5-9491-e785fd66d5ec

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA207476

Listing Expiration 2026-12-31

Marketing Start 2017-01-30

Pharmacologic Class

Established (EPC)

proton pump inhibitor [epc]

Mechanism of Action

proton pump inhibitors [moa] cytochrome p450 2c19 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69097913

Hyphenated Format 69097-913

Supplemental Identifiers

RxCUI

616539 616541

UPC

0369097914028 0369097913021

UNII

KG60484QX9 8MDF5V39QO

NUI

N0000175525 N0000000147 N0000182140

Packaging Origin

Original Packager

true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name omeprazole sodium bicarbonate (source: ndc)

Generic Name omeprazole sodium bicarbonate (source: ndc)

Application Number ANDA207476 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

20 mg/1
1100 mg/1

source: ndc

Packaging

30 CAPSULE in 1 BOTTLE (69097-913-02)
500 CAPSULE in 1 BOTTLE (69097-913-12)

source: ndc

Packages (2)

69097-913-02 30 CAPSULE in 1 BOTTLE (69097-913-02) 69097-913-12 500 CAPSULE in 1 BOTTLE (69097-913-12)

Ingredients (2)

omeprazole (20 mg/1) sodium bicarbonate (1100 mg/1)

Linked Drug Pages (1)

omeprazole sodium bicarbonate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "d7eae0fc-9dfd-48d5-9491-e785fd66d5ec", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000182140"], "upc": ["0369097914028", "0369097913021"], "unii": ["KG60484QX9", "8MDF5V39QO"], "rxcui": ["616539", "616541"], "spl_set_id": ["9cdde58a-ae8a-451f-92cf-cab178e4ba92"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]"], "manufacturer_name": ["Cipla USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (69097-913-02)", "package_ndc": "69097-913-02", "marketing_start_date": "20170130"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (69097-913-12)", "package_ndc": "69097-913-12", "marketing_start_date": "20170130"}], "brand_name": "omeprazole sodium bicarbonate", "product_id": "69097-913_d7eae0fc-9dfd-48d5-9491-e785fd66d5ec", "dosage_form": "CAPSULE", "pharm_class": ["Alkalinizing Activity [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "69097-913", "generic_name": "omeprazole sodium bicarbonate", "labeler_name": "Cipla USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "omeprazole sodium bicarbonate", "active_ingredients": [{"name": "OMEPRAZOLE", "strength": "20 mg/1"}, {"name": "SODIUM BICARBONATE", "strength": "1100 mg/1"}], "application_number": "ANDA207476", "marketing_category": "ANDA", "marketing_start_date": "20170130", "listing_expiration_date": "20261231"}