omeprazole

Generic: omeprazole

Labeler: walgreen company
NDC Directory HUMAN OTC DRUG NDA Inactive Finished

Drug Facts

Product Profile

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

omeprazole 20 mg/1

Manufacturer
Walgreen Company

Identifiers & Regulatory

Product NDC 0363-0915
Product ID 0363-0915_364bb6a8-58c8-460d-92db-c25b9eed8d2b
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA022032
Listing Expiration 2026-12-31
Marketing Start 2008-02-27

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 03630915
Hyphenated Format 0363-0915

Supplemental Identifiers

RxCUI
402014
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 NDA022032 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (0363-0915-01) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE
  • 3 BOTTLE in 1 CARTON (0363-0915-03) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE
  • 2 CARTON in 1 CARTON (0363-0915-30) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK
  • 3 CARTON in 1 CARTON (0363-0915-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK
source: ndc

Packages (4)

0363-0915-01 1 BOTTLE in 1 CARTON (0363-0915-01) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE 0363-0915-03 3 BOTTLE in 1 CARTON (0363-0915-03) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE 0363-0915-30 2 CARTON in 1 CARTON (0363-0915-30) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK 0363-0915-55 3 CARTON in 1 CARTON (0363-0915-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK

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": "364bb6a8-58c8-460d-92db-c25b9eed8d2b", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000182140"], "unii": ["KG60484QX9"], "rxcui": ["402014"], "spl_set_id": ["30a893d2-198a-4184-81b4-02399324ff29"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]"], "manufacturer_name": ["Walgreen Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0363-0915-01)  / 14 TABLET, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "0363-0915-01", "marketing_start_date": "20101006"}, {"sample": false, "description": "3 BOTTLE in 1 CARTON (0363-0915-03)  / 14 TABLET, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "0363-0915-03", "marketing_start_date": "20110325"}, {"sample": false, "description": "2 CARTON in 1 CARTON (0363-0915-30)  / 14 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK", "package_ndc": "0363-0915-30", "marketing_start_date": "20080227"}, {"sample": false, "description": "3 CARTON in 1 CARTON (0363-0915-55)  / 14 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK", "package_ndc": "0363-0915-55", "marketing_start_date": "20080227"}], "brand_name": "omeprazole", "product_id": "0363-0915_364bb6a8-58c8-460d-92db-c25b9eed8d2b", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "0363-0915", "generic_name": "Omeprazole", "labeler_name": "Walgreen Company", "product_type": "HUMAN OTC DRUG", "brand_name_base": "omeprazole", "active_ingredients": [{"name": "OMEPRAZOLE", "strength": "20 mg/1"}], "application_number": "NDA022032", "marketing_category": "NDA", "marketing_start_date": "20080227", "listing_expiration_date": "20261231"}