omeprazole

Generic: omeprazole magnesium

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

Drug Facts

Product Profile

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

omeprazole magnesium 20 mg/1

Manufacturer
Walgreen Company

Identifiers & Regulatory

Product NDC 0363-6089
Product ID 0363-6089_cc051c20-36b7-4eb6-95e5-65734ef65458
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA216096
Listing Expiration 2026-12-31
Marketing Start 2024-04-09

Pharmacologic Class

Classes
cytochrome p450 2c19 inhibitors [moa] proton pump inhibitor [epc] proton pump inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03636089
Hyphenated Format 0363-6089

Supplemental Identifiers

RxCUI
198051
UPC
0311917042213
UNII
426QFE7XLK

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 magnesium (source: ndc)
Application Number ANDA216096 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0363-6089-01)
  • 3 BOTTLE in 1 CARTON (0363-6089-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
source: ndc

Packages (2)

0363-6089-01 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0363-6089-01) 0363-6089-03 3 BOTTLE in 1 CARTON (0363-6089-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE

Ingredients (1)

omeprazole magnesium (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": "cc051c20-36b7-4eb6-95e5-65734ef65458", "openfda": {"upc": ["0311917042213"], "unii": ["426QFE7XLK"], "rxcui": ["198051"], "spl_set_id": ["f56ff74d-116d-4a75-87dc-41c309f03918"], "manufacturer_name": ["Walgreen Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0363-6089-01)", "package_ndc": "0363-6089-01", "marketing_start_date": "20240409"}, {"sample": false, "description": "3 BOTTLE in 1 CARTON (0363-6089-03)  / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE", "package_ndc": "0363-6089-03", "marketing_start_date": "20240409"}], "brand_name": "omeprazole", "product_id": "0363-6089_cc051c20-36b7-4eb6-95e5-65734ef65458", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "0363-6089", "generic_name": "Omeprazole magnesium", "labeler_name": "Walgreen Company", "product_type": "HUMAN OTC DRUG", "brand_name_base": "omeprazole", "active_ingredients": [{"name": "OMEPRAZOLE MAGNESIUM", "strength": "20 mg/1"}], "application_number": "ANDA216096", "marketing_category": "ANDA", "marketing_start_date": "20240409", "listing_expiration_date": "20261231"}