Home NDC 45802-888 omeprazole
Product NDC 45802-888
11-digit product format 458020888
Labeler code 45802
Product ID 45802-888_390ed372-f284-46b1-92bd-c2432fe6920b
Type HUMAN OTC DRUG
Nonproprietary name Omeprazole
Dosage form TABLET, DELAYED RELEASE
Route ORAL
Labeler Padagis Israel Pharmaceuticals Ltd
Application NDA022032
Marketing category NDA
Marketing start 2008-02-25
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 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 45802-888-30 omeprazole 14 in 1 CARTON TABLET, DELAYED RELEASE 14 7 45802-888-30 omeprazole 2 in 1 CARTON TABLET, DELAYED RELEASE 2 7 45802-888-55 omeprazole 14 in 1 CARTON TABLET, DELAYED RELEASE 14 7 45802-888-55 omeprazole 3 in 1 CARTON TABLET, DELAYED RELEASE 3 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OMEPRAZOLE ACTIVE INGREDIENT KG60484QX9 OMEPRAZOLE TABLET, DELAYED RELEASE [PERRIGO NEW YORK INC] 3 OMEPRAZOLE ACTIVE MOIETY KG60484QX9 OMEPRAZOLE TABLET, DELAYED RELEASE [PERRIGO NEW YORK INC] 3 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ OMEPRAZOLE TABLET, DELAYED RELEASE [PERRIGO NEW YORK INC] 3 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 OMEPRAZOLE TABLET, DELAYED RELEASE [PERRIGO NEW YORK INC] 3 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT OMEPRAZOLE TABLET, DELAYED RELEASE [PERRIGO NEW YORK INC] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO OMEPRAZOLE TABLET, DELAYED RELEASE [PERRIGO NEW YORK INC] 3 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X OMEPRAZOLE TABLET, DELAYED RELEASE [PERRIGO NEW YORK INC] 3 MONOETHANOLAMINE INACTIVE INGREDIENT 5KV86114PT OMEPRAZOLE TABLET, DELAYED RELEASE [PERRIGO NEW YORK INC] 3 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 OMEPRAZOLE TABLET, DELAYED RELEASE [PERRIGO NEW YORK INC] 3 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J OMEPRAZOLE TABLET, DELAYED RELEASE [PERRIGO NEW YORK INC] 3 SODIUM STEARATE INACTIVE INGREDIENT QU7E2XA9TG OMEPRAZOLE TABLET, DELAYED RELEASE [PERRIGO NEW YORK INC] 3 SODIUM STEARYL FUMARATE INACTIVE INGREDIENT 7CV7WJK4UI OMEPRAZOLE TABLET, DELAYED RELEASE [PERRIGO NEW YORK INC] 3 TALC INACTIVE INGREDIENT 7SEV7J4R1U OMEPRAZOLE TABLET, DELAYED RELEASE [PERRIGO NEW YORK INC] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP OMEPRAZOLE TABLET, DELAYED RELEASE [PERRIGO NEW YORK INC] 3 TRIETHYL CITRATE INACTIVE INGREDIENT 8Z96QXD6UM OMEPRAZOLE TABLET, DELAYED RELEASE [PERRIGO NEW YORK INC] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 45802-888 OMEPRAZOLE TABLET, DELAYED RELEASE [PADAGIS ISRAEL PHARMACEUTICALS LTD] 7 Current NDC, Legacy NDC, 4 package rows 20250305_cb47354c-297b-4dc2-85af-242acc967b56.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 45802-888-30 45802088830 2 CARTON in 1 CARTON (45802-888-30) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK 2 carton 2008-02-25 0000-00-00 No No Current 45802-888-55 45802088855 3 CARTON in 1 CARTON (45802-888-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK 3 carton 2008-11-06 0000-00-00 No No Current