Home NDC 0536-1448 rugby omeprazole
Product NDC 0536-1448
11-digit product format 005361448
Labeler code 0536
Product ID 0536-1448_bc786388-cb4d-4210-9124-39a4bcbb7d38
Type HUMAN OTC DRUG
Nonproprietary name Omeprazole
Dosage form TABLET, DELAYED RELEASE
Route ORAL
Labeler Rugby Laboratories
Application NDA022032
Marketing category NDA
Marketing start 2025-04-15
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 N022032-001 OMEPRAZOLE OMEPRAZOLE 20MG TABLET, DELAYED RELEASE / ORAL RLD, RS 2007-12-04
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022032-001 12599565 2030-01-31 Drug product 2026-05-11
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 N022032-001 OMEPRAZOLE 20MG TABLET, DELAYED RELEASE / ORAL RLD, RS 2007-12-04 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 N022032-001 12599565 2030-01-31 Drug product 2026-05-11 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 3 · 58 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base rugby 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 402014 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 0536-1448-13 rugby omeprazole 3 in 1 CARTON TABLET, DELAYED RELEASE 3 2 0536-1448-13 rugby omeprazole 14 in 1 BOTTLE TABLET, DELAYED RELEASE 14 2 0536-1448-88 rugby omeprazole 14 in 1 BOTTLE TABLET, DELAYED RELEASE 14 2 0536-1448-88 rugby omeprazole 1 in 1 CARTON TABLET, DELAYED RELEASE 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0536-1448 RUGBY OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [RUGBY LABORATORIES] 2 Current NDC, 4 package rows 20250418_61952807-f38d-4e7a-8646-a8ec85d7fb37.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0536-1448-13 00536144813 3 BOTTLE in 1 CARTON (0536-1448-13) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE 3 bottle 2025-04-15 No No Current 0536-1448-88 00536144888 1 BOTTLE in 1 CARTON (0536-1448-88) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE 1 bottle 2025-04-15 No No Current