omeprazole and sodium bicarbonate (58602-725)

Drug Facts

Product Profile

Brand Name omeprazole and sodium bicarbonate

Generic Name omeprazole and sodium bicarbonate

Labeler aurohealth llc

Dosage Form CAPSULE

Routes

ORAL

Active Ingredients

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

Manufacturer

Aurohealth LLC

Identifiers & Regulatory

Product NDC 58602-725

Product ID 58602-725_48c99760-39f6-4e1f-ae95-16a52fc10898

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA204923

Listing Expiration 2026-12-31

Marketing Start 2023-12-22

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 58602725

Hyphenated Format 58602-725

Supplemental Identifiers

RxCUI

616539

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 and sodium bicarbonate (source: ndc)

Generic Name omeprazole and sodium bicarbonate (source: ndc)

Application Number ANDA204923 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

20 mg/1
1100 mg/1

source: ndc

Packaging

1 BOTTLE in 1 CARTON (58602-725-05) / 14 CAPSULE in 1 BOTTLE
2 BOTTLE in 1 CARTON (58602-725-57) / 14 CAPSULE in 1 BOTTLE
3 BOTTLE in 1 CARTON (58602-725-60) / 14 CAPSULE in 1 BOTTLE

source: ndc

Packages (3)

58602-725-05 1 BOTTLE in 1 CARTON (58602-725-05) / 14 CAPSULE in 1 BOTTLE 58602-725-57 2 BOTTLE in 1 CARTON (58602-725-57) / 14 CAPSULE in 1 BOTTLE 58602-725-60 3 BOTTLE in 1 CARTON (58602-725-60) / 14 CAPSULE in 1 BOTTLE

Ingredients (2)

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

Linked Drug Pages (1)

OMEPRAZOLE AND SODIUM BICARBONATE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "48c99760-39f6-4e1f-ae95-16a52fc10898", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000182140"], "unii": ["KG60484QX9", "8MDF5V39QO"], "rxcui": ["616539"], "spl_set_id": ["88ad2e92-2228-49b2-bcee-1770fd30cb14"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]"], "manufacturer_name": ["Aurohealth LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-725-05)  / 14 CAPSULE in 1 BOTTLE", "package_ndc": "58602-725-05", "marketing_start_date": "20231222"}, {"sample": false, "description": "2 BOTTLE in 1 CARTON (58602-725-57)  / 14 CAPSULE in 1 BOTTLE", "package_ndc": "58602-725-57", "marketing_start_date": "20231222"}, {"sample": false, "description": "3 BOTTLE in 1 CARTON (58602-725-60)  / 14 CAPSULE in 1 BOTTLE", "package_ndc": "58602-725-60", "marketing_start_date": "20231222"}], "brand_name": "OMEPRAZOLE AND SODIUM BICARBONATE", "product_id": "58602-725_48c99760-39f6-4e1f-ae95-16a52fc10898", "dosage_form": "CAPSULE", "pharm_class": ["Alkalinizing Activity [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "58602-725", "generic_name": "OMEPRAZOLE AND SODIUM BICARBONATE", "labeler_name": "Aurohealth LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "OMEPRAZOLE AND SODIUM BICARBONATE", "active_ingredients": [{"name": "OMEPRAZOLE", "strength": "20 mg/1"}, {"name": "SODIUM BICARBONATE", "strength": "1100 mg/1"}], "application_number": "ANDA204923", "marketing_category": "ANDA", "marketing_start_date": "20231222", "listing_expiration_date": "20261231"}