omeprazole and sodium bicarbonate (70954-797)

Drug Facts

Product Profile

Brand Name omeprazole and sodium bicarbonate

Generic Name omeprazole and sodium bicarbonate

Labeler ani pharmaceuticals, inc.

Dosage Form POWDER, FOR SUSPENSION

Routes

ORAL

Active Ingredients

omeprazole 20 mg/1, sodium bicarbonate 1680 mg/1

Manufacturer

ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 70954-797

Product ID 70954-797_63c3bd6c-a586-4ec0-8f45-ed936936dfeb

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA219161

Listing Expiration 2026-12-31

Marketing Start 2026-01-15

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 70954797

Hyphenated Format 70954-797

Supplemental Identifiers

RxCUI

753557 753562

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 ANDA219161 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

20 mg/1
1680 mg/1

source: ndc

Packaging

30 PACKET in 1 CARTON (70954-797-20) / 1 POWDER, FOR SUSPENSION in 1 PACKET (70954-797-10)

source: ndc

Packages (1)

70954-797-20 30 PACKET in 1 CARTON (70954-797-20) / 1 POWDER, FOR SUSPENSION in 1 PACKET (70954-797-10)

Ingredients (2)

omeprazole (20 mg/1) sodium bicarbonate (1680 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": "63c3bd6c-a586-4ec0-8f45-ed936936dfeb", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000182140"], "unii": ["KG60484QX9", "8MDF5V39QO"], "rxcui": ["753557", "753562"], "spl_set_id": ["63c3bd6c-a586-4ec0-8f45-ed936936dfeb"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]"], "manufacturer_name": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 PACKET in 1 CARTON (70954-797-20)  / 1 POWDER, FOR SUSPENSION in 1 PACKET (70954-797-10)", "package_ndc": "70954-797-20", "marketing_start_date": "20260115"}], "brand_name": "Omeprazole and Sodium Bicarbonate", "product_id": "70954-797_63c3bd6c-a586-4ec0-8f45-ed936936dfeb", "dosage_form": "POWDER, FOR SUSPENSION", "pharm_class": ["Alkalinizing Activity [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "70954-797", "generic_name": "Omeprazole and Sodium Bicarbonate", "labeler_name": "ANI Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Omeprazole and Sodium Bicarbonate", "active_ingredients": [{"name": "OMEPRAZOLE", "strength": "20 mg/1"}, {"name": "SODIUM BICARBONATE", "strength": "1680 mg/1"}], "application_number": "ANDA219161", "marketing_category": "ANDA", "marketing_start_date": "20260115", "listing_expiration_date": "20261231"}