omeprazole

Generic: omeprazole

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

Drug Facts

Product Profile

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

omeprazole 20 mg/1

Manufacturer
Walgreens Company

Identifiers & Regulatory

Product NDC 0363-1607
Product ID 0363-1607_663561b1-18c8-7edf-9559-d226dc32a683
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA207740
Listing Expiration 2026-12-31
Marketing Start 2020-01-15

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 03631607
Hyphenated Format 0363-1607

Supplemental Identifiers

RxCUI
402014
UNII
KG60484QX9
NUI
N0000175525 N0000000147 N0000182140

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 ANDA207740 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 14 TABLET, DELAYED RELEASE in 1 BOTTLE (0363-1607-14)
  • 2 BOTTLE in 1 CARTON (0363-1607-28) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (0363-1607-14)
  • 3 BOTTLE in 1 CARTON (0363-1607-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (0363-1607-14)
source: ndc

Packages (3)

0363-1607-14 14 TABLET, DELAYED RELEASE in 1 BOTTLE (0363-1607-14) 0363-1607-28 2 BOTTLE in 1 CARTON (0363-1607-28) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (0363-1607-14) 0363-1607-42 3 BOTTLE in 1 CARTON (0363-1607-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (0363-1607-14)

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": "663561b1-18c8-7edf-9559-d226dc32a683", "openfda": {"nui": ["N0000175525", "N0000000147", "N0000182140"], "unii": ["KG60484QX9"], "rxcui": ["402014"], "spl_set_id": ["5e2994fc-8f44-f6e4-71fe-44a215aa93a9"], "pharm_class_epc": ["Proton Pump Inhibitor [EPC]"], "pharm_class_moa": ["Proton Pump Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]"], "manufacturer_name": ["Walgreens Company"]}, "finished": true, "packaging": [{"sample": false, "description": "14 TABLET, DELAYED RELEASE in 1 BOTTLE (0363-1607-14)", "package_ndc": "0363-1607-14", "marketing_start_date": "20200115"}, {"sample": false, "description": "2 BOTTLE in 1 CARTON (0363-1607-28)  / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (0363-1607-14)", "package_ndc": "0363-1607-28", "marketing_start_date": "20200115"}, {"sample": false, "description": "3 BOTTLE in 1 CARTON (0363-1607-42)  / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (0363-1607-14)", "package_ndc": "0363-1607-42", "marketing_start_date": "20200115"}], "brand_name": "Omeprazole", "product_id": "0363-1607_663561b1-18c8-7edf-9559-d226dc32a683", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Cytochrome P450 2C19 Inhibitors [MoA]", "Proton Pump Inhibitor [EPC]", "Proton Pump Inhibitors [MoA]"], "product_ndc": "0363-1607", "generic_name": "Omeprazole", "labeler_name": "Walgreens Company", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Omeprazole", "active_ingredients": [{"name": "OMEPRAZOLE", "strength": "20 mg/1"}], "application_number": "ANDA207740", "marketing_category": "ANDA", "marketing_start_date": "20200115", "listing_expiration_date": "20261231"}