zegerid

Generic: omeprazole and sodium bicarbonate

Labeler: santarus, inc..
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name zegerid
Generic Name omeprazole and sodium bicarbonate
Labeler santarus, inc..
Dosage Form POWDER, FOR SUSPENSION
Routes
ORAL
Active Ingredients

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

Manufacturer
Santarus, Inc..

Identifiers & Regulatory

Product NDC 68012-054
Product ID 68012-054_bc93408c-bea8-429d-a2f9-d587fd3204c3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021636
Listing Expiration 2026-12-31
Marketing Start 2014-06-15

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 68012054
Hyphenated Format 68012-054

Supplemental Identifiers

RxCUI
616539 616541 646344 646352 753557 753562 753601 753603
UPC
0368012102304 0368012104308
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 zegerid (source: ndc)
Generic Name omeprazole and sodium bicarbonate (source: ndc)
Application Number NDA021636 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
  • 1680 mg/1
source: ndc
Packaging
  • 3 PACKET in 1 CARTON (68012-054-03) / 1 POWDER, FOR SUSPENSION in 1 PACKET
  • 30 PACKET in 1 CARTON (68012-054-30) / 1 POWDER, FOR SUSPENSION in 1 PACKET
source: ndc

Packages (2)

68012-054-03 3 PACKET in 1 CARTON (68012-054-03) / 1 POWDER, FOR SUSPENSION in 1 PACKET 68012-054-30 30 PACKET in 1 CARTON (68012-054-30) / 1 POWDER, FOR SUSPENSION in 1 PACKET

Ingredients (2)

omeprazole (40 mg/1) sodium bicarbonate (1680 mg/1)

Linked Drug Pages (1)

ZEGERID ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "bc93408c-bea8-429d-a2f9-d587fd3204c3", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000182140"], "upc": ["0368012102304", "0368012104308"], "unii": ["KG60484QX9", "8MDF5V39QO"], "rxcui": ["616539", "616541", "646344", "646352", "753557", "753562", "753601", "753603"], "spl_set_id": ["cd6868b9-5824-442b-8d65-4db29ecb70a4"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]"], "manufacturer_name": ["Santarus, Inc.."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 PACKET in 1 CARTON (68012-054-03)  / 1 POWDER, FOR SUSPENSION in 1 PACKET", "package_ndc": "68012-054-03", "marketing_start_date": "20140615"}, {"sample": false, "description": "30 PACKET in 1 CARTON (68012-054-30)  / 1 POWDER, FOR SUSPENSION in 1 PACKET", "package_ndc": "68012-054-30", "marketing_start_date": "20140615"}], "brand_name": "ZEGERID", "product_id": "68012-054_bc93408c-bea8-429d-a2f9-d587fd3204c3", "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": "68012-054", "generic_name": "omeprazole and sodium bicarbonate", "labeler_name": "Santarus, Inc..", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ZEGERID", "active_ingredients": [{"name": "OMEPRAZOLE", "strength": "40 mg/1"}, {"name": "SODIUM BICARBONATE", "strength": "1680 mg/1"}], "application_number": "NDA021636", "marketing_category": "NDA", "marketing_start_date": "20140615", "listing_expiration_date": "20261231"}