omeprazole/sodiium bicarbonate (72189-568)

Drug Facts

Product Profile

Brand Name omeprazole/sodiium bicarbonate

Generic Name omeprazole/sodiium bicarbonate

Labeler direct_rx

Dosage Form CAPSULE

Routes

ORAL

Active Ingredients

omeprazole 40 mg/1, sodium bicarbonate 1100 mg/1

Manufacturer

Direct_rx

Identifiers & Regulatory

Product NDC 72189-568

Product ID 72189-568_1f7f63c1-17c3-9a05-e063-6394a90abc6f

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA204228

Listing Expiration 2026-12-31

Marketing Start 2024-08-12

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 72189568

Hyphenated Format 72189-568

Supplemental Identifiers

RxCUI

616541

UNII

KG60484QX9 8MDF5V39QO

NUI

N0000175525 N0000000147 N0000182140

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/sodiium bicarbonate (source: ndc)

Generic Name omeprazole/sodiium bicarbonate (source: ndc)

Application Number ANDA204228 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

40 mg/1
1100 mg/1

source: ndc

Packaging

30 CAPSULE in 1 BOTTLE (72189-568-30)

source: ndc

Packages (1)

72189-568-30 30 CAPSULE in 1 BOTTLE (72189-568-30)

Ingredients (2)

omeprazole (40 mg/1) sodium bicarbonate (1100 mg/1)

Linked Drug Pages (1)

Omeprazole/Sodiium Bicarbonate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "1f7f63c1-17c3-9a05-e063-6394a90abc6f", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000182140"], "unii": ["KG60484QX9", "8MDF5V39QO"], "rxcui": ["616541"], "spl_set_id": ["1f7f63c1-17c2-9a05-e063-6394a90abc6f"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]"], "manufacturer_name": ["Direct_rx"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (72189-568-30)", "package_ndc": "72189-568-30", "marketing_start_date": "20240812"}], "brand_name": "Omeprazole/Sodiium Bicarbonate", "product_id": "72189-568_1f7f63c1-17c3-9a05-e063-6394a90abc6f", "dosage_form": "CAPSULE", "pharm_class": ["Alkalinizing Activity [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "72189-568", "generic_name": "Omeprazole/Sodiium Bicarbonate", "labeler_name": "Direct_rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Omeprazole/Sodiium Bicarbonate", "active_ingredients": [{"name": "OMEPRAZOLE", "strength": "40 mg/1"}, {"name": "SODIUM BICARBONATE", "strength": "1100 mg/1"}], "application_number": "ANDA204228", "marketing_category": "ANDA", "marketing_start_date": "20240812", "listing_expiration_date": "20261231"}