Home NDC 0904-6144-61 Omeprazole
Product NDC 0904-6144
Requested package NDC 0904-6144-61
11-digit product format 009046144
Labeler code 0904
Product ID 0904-6144_bd975546-1306-4e76-8493-d0735369589b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Omeprazole
Dosage form CAPSULE, DELAYED RELEASE
Route ORAL
Labeler Major Pharmaceuticals
Application ANDA076515
Marketing category ANDA
Marketing start 2010-07-16
Marketing end 0000-00-00
Substance OMEPRAZOLE
Active strength 40 mg/1
Pharmacologic classes Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record 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 A076515-001 OMEPRAZOLE OMEPRAZOLE 40MG CAPSULE, DELAYED REL PELLETS / ORAL AB 2009-01-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076515-001 AB
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 A076515-001 OMEPRAZOLE 40MG CAPSULE, DELAYED REL PELLETS / ORAL AB 2009-01-21 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A076515-001 AB 1 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 · 1 matching rows.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OMEPRAZOLE ACTIVE INGREDIENT KG60484QX9 OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS] 3 OMEPRAZOLE ACTIVE MOIETY KG60484QX9 OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS] 3 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS] 3 CARRAGEENAN INACTIVE INGREDIENT 5C69YCD2YJ OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS] 3 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS] 3 DIBUTYL SEBACATE INACTIVE INGREDIENT 4W5IH7FLNY OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS] 3 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS] 3 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS] 3 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS] 3 HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED INACTIVE INGREDIENT 2165RE0K14 OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS] 3 HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST) INACTIVE INGREDIENT 87Y6436BKR OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS] 3 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS] 3 POTASSIUM CHLORIDE INACTIVE INGREDIENT 660YQ98I10 OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS] 3 POVIDONES INACTIVE INGREDIENT FZ989GH94E OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS] 3 TALC INACTIVE INGREDIENT 7SEV7J4R1U OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS] 3
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0904-6144-61 00904614461 100 BLISTER PACK in 1 CARTON (0904-6144-61) > 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK 100 blister pack 2010-07-16 0000-00-00 No No Current