omeprazole, sodium bicarbonate (53041-663)

Drug Facts

Product Profile

Brand Name omeprazole, sodium bicarbonate

Generic Name omeprazole, sodium bicarbonate

Labeler guardian drug company

Dosage Form CAPSULE

Routes

ORAL

Active Ingredients

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

Manufacturer

Guardian Drug Company

Identifiers & Regulatory

Product NDC 53041-663

Product ID 53041-663_27536955-37df-4dcc-ad75-2b364fe95460

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA212587

Listing Expiration 2026-12-31

Marketing Start 2020-05-07

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 53041663

Hyphenated Format 53041-663

Supplemental Identifiers

RxCUI

616539 616541

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 ANDA212587 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

40 mg/1
1100 mg/1

source: ndc

Packaging

30 CAPSULE in 1 BOTTLE (53041-663-77)

source: ndc

Packages (1)

53041-663-77 30 CAPSULE in 1 BOTTLE (53041-663-77)

Ingredients (2)

omeprazole (40 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": "27536955-37df-4dcc-ad75-2b364fe95460", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000182140"], "unii": ["KG60484QX9", "8MDF5V39QO"], "rxcui": ["616539", "616541"], "spl_set_id": ["e5c6c2cf-fb3b-456a-a0a0-be396d6f8319"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]"], "manufacturer_name": ["Guardian Drug Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (53041-663-77)", "package_ndc": "53041-663-77", "marketing_start_date": "20200507"}], "brand_name": "Omeprazole, Sodium bicarbonate", "product_id": "53041-663_27536955-37df-4dcc-ad75-2b364fe95460", "dosage_form": "CAPSULE", "pharm_class": ["Alkalinizing Activity [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "53041-663", "generic_name": "Omeprazole, Sodium bicarbonate", "labeler_name": "Guardian Drug Company", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Omeprazole, Sodium bicarbonate", "active_ingredients": [{"name": "OMEPRAZOLE", "strength": "40 mg/1"}, {"name": "SODIUM BICARBONATE", "strength": "1100 mg/1"}], "application_number": "ANDA212587", "marketing_category": "ANDA", "marketing_start_date": "20200507", "listing_expiration_date": "20261231"}