Home NDC 0363-1819 omeprazole
Product NDC 0363-1819
11-digit product format 003631819
Labeler code 0363
Product ID 0363-1819_d56182bb-d424-4890-93c6-bca29194af8c
Type HUMAN OTC DRUG
Nonproprietary name omeprazole
Dosage form TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
Route ORAL
Labeler Walgreen Company
Application NDA209400
Marketing category NDA
Marketing start 2018-03-01
Substance OMEPRAZOLE
Active strength 20 mg/1
Pharmacologic classes Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N209400-001 OMEPRAZOLE OMEPRAZOLE 20MG TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL RLD, RS 2017-07-05
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N209400-001 10076494 2036-12-08 Drug product 2018-09-18 N209400-001 10835488 2036-12-08 Drug product 2020-11-23
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N209400-001 OMEPRAZOLE 20MG TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL RLD, RS 2017-07-05 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-01 22:54:32 2026-06 N209400-001 10076494 2036-12-08 Drug product 2018-09-18 a50c72e98297…2026-08-01 22:54:32 2026-06 N209400-001 10835488 2036-12-08 Drug product 2020-11-23 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 18 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base omeprazole
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OMEPRAZOLE 20 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination KG60484QX9 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2003656 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0363-1819-55 omeprazole 14 in 1 CARTON TABLET, ORALLY DISINTEGRATING, D 14 5 0363-1819-55 omeprazole 3 in 1 CARTON TABLET, ORALLY DISINTEGRATING, D 3 5 0363-1819-74 omeprazole 1 in 1 BLISTER PACK TABLET, ORALLY DISINTEGRATING, D 1 5 0363-1819-74 omeprazole 14 in 1 CARTON TABLET, ORALLY DISINTEGRATING, D 14 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0363-1819 OMEPRAZOLE TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [WALGREEN COMPANY] 5 Current NDC, Legacy NDC, 4 package rows 20250125_064f048c-eddd-4370-9ee4-706f9f00c8d2.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0363-1819-55 00363181955 3 CARTON in 1 CARTON (0363-1819-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK 3 carton 2018-03-01 0000-00-00 No No Current 0363-1819-74 00363181974 14 BLISTER PACK in 1 CARTON (0363-1819-74) / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK 14 blister pack 2018-03-06 0000-00-00 No No Current