omeprazole

Generic: omeprazole

Labeler: allegiant health
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name omeprazole
Generic Name omeprazole
Labeler allegiant health
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

omeprazole 20 mg/1

Manufacturer
Allegiant Health

Identifiers & Regulatory

Product NDC 69168-476
Product ID 69168-476_37309c28-8650-401e-9a39-6b52112e0baf
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA211732
Listing Expiration 2026-12-31
Marketing Start 2025-03-21

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 69168476
Hyphenated Format 69168-476

Supplemental Identifiers

RxCUI
402014
UPC
0369168476141
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 ANDA211732 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (69168-476-14) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE
  • 14 TABLET, DELAYED RELEASE in 1 BOTTLE (69168-476-15)
  • 3 BOTTLE in 1 CARTON (69168-476-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (69168-476-61) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE
source: ndc

Packages (4)

69168-476-14 1 BOTTLE in 1 CARTON (69168-476-14) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE 69168-476-15 14 TABLET, DELAYED RELEASE in 1 BOTTLE (69168-476-15) 69168-476-42 3 BOTTLE in 1 CARTON (69168-476-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE 69168-476-61 1 BOTTLE in 1 CARTON (69168-476-61) / 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": "37309c28-8650-401e-9a39-6b52112e0baf", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000182140"], "upc": ["0369168476141"], "unii": ["KG60484QX9"], "rxcui": ["402014"], "spl_set_id": ["3344c589-c4ac-4f2d-8d32-828db4e825a6"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]"], "manufacturer_name": ["Allegiant Health"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (69168-476-14)  / 14 TABLET, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "69168-476-14", "marketing_start_date": "20250321"}, {"sample": false, "description": "14 TABLET, DELAYED RELEASE in 1 BOTTLE (69168-476-15)", "package_ndc": "69168-476-15", "marketing_start_date": "20250321"}, {"sample": false, "description": "3 BOTTLE in 1 CARTON (69168-476-42)  / 14 TABLET, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "69168-476-42", "marketing_start_date": "20250321"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (69168-476-61)  / 14 TABLET, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "69168-476-61", "marketing_start_date": "20250321"}], "brand_name": "Omeprazole", "product_id": "69168-476_37309c28-8650-401e-9a39-6b52112e0baf", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "69168-476", "generic_name": "Omeprazole", "labeler_name": "Allegiant Health", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Omeprazole", "active_ingredients": [{"name": "OMEPRAZOLE", "strength": "20 mg/1"}], "application_number": "ANDA211732", "marketing_category": "ANDA", "marketing_start_date": "20250321", "listing_expiration_date": "20261231"}