omeprazole

Generic: omeprazole

Labeler: valu merchandisers company
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name omeprazole
Generic Name omeprazole
Labeler valu merchandisers company
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

omeprazole 20 mg/1

Manufacturer
VALU MERCHANDISERS COMPANY

Identifiers & Regulatory

Product NDC 63941-997
Product ID 63941-997_9c033207-ae1c-4212-aeef-3bb5bfef6fca
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA207891
Listing Expiration 2026-12-31
Marketing Start 2018-07-20

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 63941997
Hyphenated Format 63941-997

Supplemental Identifiers

RxCUI
402014
UPC
0070038655015
UNII
KG60484QX9
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 (source: ndc)
Generic Name omeprazole (source: ndc)
Application Number ANDA207891 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (63941-997-14) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE
  • 3 BOTTLE in 1 CARTON (63941-997-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE
source: ndc

Packages (2)

63941-997-14 1 BOTTLE in 1 CARTON (63941-997-14) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE 63941-997-42 3 BOTTLE in 1 CARTON (63941-997-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE

Ingredients (1)

omeprazole (20 mg/1)

Linked Drug Pages (1)

Omeprazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "9c033207-ae1c-4212-aeef-3bb5bfef6fca", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000182140"], "upc": ["0070038655015"], "unii": ["KG60484QX9"], "rxcui": ["402014"], "spl_set_id": ["7b2d41b6-3e36-4973-b5f6-adf9b828f40d"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]"], "manufacturer_name": ["VALU MERCHANDISERS COMPANY"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (63941-997-14)  / 14 TABLET, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "63941-997-14", "marketing_start_date": "20180721"}, {"sample": false, "description": "3 BOTTLE in 1 CARTON (63941-997-42)  / 14 TABLET, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "63941-997-42", "marketing_start_date": "20180721"}], "brand_name": "Omeprazole", "product_id": "63941-997_9c033207-ae1c-4212-aeef-3bb5bfef6fca", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "63941-997", "generic_name": "Omeprazole", "labeler_name": "VALU MERCHANDISERS COMPANY", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Omeprazole", "active_ingredients": [{"name": "OMEPRAZOLE", "strength": "20 mg/1"}], "application_number": "ANDA207891", "marketing_category": "ANDA", "marketing_start_date": "20180720", "listing_expiration_date": "20261231"}