Home NDC 36800-915 TopCare Omeprazole
Product NDC 36800-915
11-digit product format 368000915
Labeler code 36800
Product ID 36800-915_e1557259-5889-4677-981e-ebd3970162c8
Type HUMAN OTC DRUG
Nonproprietary name Omeprazole
Dosage form TABLET, DELAYED RELEASE
Route ORAL
Labeler Topco Associates LLC
Application NDA022032
Marketing category NDA
Marketing start 2008-02-29
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 TopCare 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 36800-915-01 TopCare Omeprazole 1 in 1 CARTON TABLET, DELAYED RELEASE 1 8 36800-915-01 TopCare Omeprazole 14 in 1 BOTTLE TABLET, DELAYED RELEASE 14 8 36800-915-03 TopCare Omeprazole 3 in 1 CARTON TABLET, DELAYED RELEASE 3 8 36800-915-03 TopCare Omeprazole 14 in 1 BOTTLE TABLET, DELAYED RELEASE 14 8 36800-915-30 TopCare Omeprazole 14 in 1 CARTON TABLET, DELAYED RELEASE 14 8 36800-915-30 TopCare Omeprazole 2 in 1 CARTON TABLET, DELAYED RELEASE 2 8 36800-915-55 TopCare Omeprazole 3 in 1 CARTON TABLET, DELAYED RELEASE 3 8 36800-915-55 TopCare Omeprazole 14 in 1 CARTON TABLET, DELAYED RELEASE 14 8 36800-915-74 TopCare Omeprazole 1 in 1 BLISTER PACK TABLET, DELAYED RELEASE 1 8 36800-915-74 TopCare Omeprazole 14 in 1 CARTON TABLET, DELAYED RELEASE 14 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OMEPRAZOLE ACTIVE INGREDIENT KG60484QX9 TOPCARE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [TOPCO ASSOCIATES LLC] 4 OMEPRAZOLE ACTIVE MOIETY KG60484QX9 TOPCARE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [TOPCO ASSOCIATES LLC] 4 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ TOPCARE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [TOPCO ASSOCIATES LLC] 4 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 TOPCARE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [TOPCO ASSOCIATES LLC] 4 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT TOPCARE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [TOPCO ASSOCIATES LLC] 4 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO TOPCARE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [TOPCO ASSOCIATES LLC] 4 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X TOPCARE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [TOPCO ASSOCIATES LLC] 4 MONOETHANOLAMINE INACTIVE INGREDIENT 5KV86114PT TOPCARE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [TOPCO ASSOCIATES LLC] 4 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 TOPCARE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [TOPCO ASSOCIATES LLC] 4 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J TOPCARE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [TOPCO ASSOCIATES LLC] 4 SODIUM STEARATE INACTIVE INGREDIENT QU7E2XA9TG TOPCARE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [TOPCO ASSOCIATES LLC] 4 SODIUM STEARYL FUMARATE INACTIVE INGREDIENT 7CV7WJK4UI TOPCARE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [TOPCO ASSOCIATES LLC] 4 TALC INACTIVE INGREDIENT 7SEV7J4R1U TOPCARE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [TOPCO ASSOCIATES LLC] 4 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TOPCARE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [TOPCO ASSOCIATES LLC] 4 TRIETHYL CITRATE INACTIVE INGREDIENT 8Z96QXD6UM TOPCARE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [TOPCO ASSOCIATES LLC] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-915 TOPCARE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [TOPCO ASSOCIATES LLC] 8 Current NDC, Legacy NDC, 10 package rows 20250112_4d98665d-38db-4c08-8406-cc0e45f7ab7c.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 36800-915-01 36800091501 1 BOTTLE in 1 CARTON (36800-915-01) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE 1 bottle 2010-10-11 0000-00-00 No No Current 36800-915-03 36800091503 3 BOTTLE in 1 CARTON (36800-915-03) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE 3 bottle 2011-12-28 0000-00-00 No No Current 36800-915-30 36800091530 2 CARTON in 1 CARTON (36800-915-30) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK 2 carton 2008-02-29 0000-00-00 No No Current 36800-915-55 36800091555 3 CARTON in 1 CARTON (36800-915-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK 3 carton 2008-02-29 0000-00-00 No No Current 36800-915-74 36800091574 14 BLISTER PACK in 1 CARTON (36800-915-74) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK 14 blister pack 2008-02-29 0000-00-00 No No Current