Home NDC 41163-634 equaline omeprazole
Product NDC 41163-634
11-digit product format 411630634
Labeler code 41163
Product ID 41163-634_d806739f-7f7b-42ae-af48-d1b0b22d3eef
Type HUMAN OTC DRUG
Nonproprietary name omeprazole
Dosage form TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
Route ORAL
Labeler United Natural Foods, Inc. dba UNFI
Application NDA209400
Marketing category NDA
Marketing start 2018-10-11
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 equaline 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 41163-634-74 equaline omeprazole 14 in 1 CARTON TABLET, ORALLY DISINTEGRATING, D 14 4 41163-634-74 equaline omeprazole 1 in 1 BLISTER PACK TABLET, ORALLY DISINTEGRATING, D 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 41163-634 EQUALINE OMEPRAZOLE (OMEPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [UNITED NATURAL FOODS, INC. DBA UNFI] 4 Current NDC, Legacy NDC, 2 package rows 20231004_78743f3b-257e-49df-98cd-6cc0e1b4e370.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 41163-634-74 41163063474 14 BLISTER PACK in 1 CARTON (41163-634-74) / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK 14 blister pack 2018-10-11 0000-00-00 No No Current