omeprazole and sodium bicarbonate (27241-030)

Drug Facts

Product Profile

Brand Name omeprazole and sodium bicarbonate

Generic Name omeprazole and sodium bicarbonate

Labeler ajanta pharma usa inc.

Dosage Form FOR SUSPENSION

Routes

ORAL

Active Ingredients

omeprazole 40 mg/1, sodium bicarbonate 1680 mg/1

Manufacturer

Ajanta Pharma USA Inc.

Identifiers & Regulatory

Product NDC 27241-030

Product ID 27241-030_e627be01-7cc1-4a03-a183-1a5cfe92f9f0

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA205545

Listing Expiration 2027-12-31

Marketing Start 2016-07-27

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 27241030

Hyphenated Format 27241-030

Supplemental Identifiers

RxCUI

753557 753562

UPC

0327241030314

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 ANDA205545 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

40 mg/1
1680 mg/1

source: ndc

Packaging

30 FOR SUSPENSION in 1 CARTON (27241-030-31)
1 FOR SUSPENSION in 1 PACKET (27241-030-62)

source: ndc

Packages (2)

27241-030-31 30 FOR SUSPENSION in 1 CARTON (27241-030-31) 27241-030-62 1 FOR SUSPENSION in 1 PACKET (27241-030-62)

Ingredients (2)

omeprazole (40 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": "e627be01-7cc1-4a03-a183-1a5cfe92f9f0", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000182140"], "upc": ["0327241030314"], "unii": ["KG60484QX9", "8MDF5V39QO"], "rxcui": ["753557", "753562"], "spl_set_id": ["bd84ca00-6352-4cb3-bce2-05f4a5005a94"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]"], "manufacturer_name": ["Ajanta Pharma USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 FOR SUSPENSION in 1 CARTON (27241-030-31)", "package_ndc": "27241-030-31", "marketing_start_date": "20160727"}, {"sample": false, "description": "1 FOR SUSPENSION in 1 PACKET (27241-030-62)", "package_ndc": "27241-030-62", "marketing_start_date": "20160727"}], "brand_name": "Omeprazole and Sodium Bicarbonate", "product_id": "27241-030_e627be01-7cc1-4a03-a183-1a5cfe92f9f0", "dosage_form": "FOR SUSPENSION", "pharm_class": ["Alkalinizing Activity [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "27241-030", "generic_name": "Omeprazole and Sodium Bicarbonate", "labeler_name": "Ajanta Pharma USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Omeprazole and Sodium Bicarbonate", "active_ingredients": [{"name": "OMEPRAZOLE", "strength": "40 mg/1"}, {"name": "SODIUM BICARBONATE", "strength": "1680 mg/1"}], "application_number": "ANDA205545", "marketing_category": "ANDA", "marketing_start_date": "20160727", "listing_expiration_date": "20271231"}