Home NDC 52959-722 Omeprazole
Product NDC 52959-722
11-digit product format 529590722
Labeler code 52959
Product ID 52959-722_beac7b55-14cd-45b4-8024-bd117222e6cc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Omeprazole
Dosage form CAPSULE, DELAYED RELEASE
Route ORAL
Labeler H.J. Harkins Company, Inc.
Application ANDA075876
Marketing category ANDA
Marketing start 2011-01-14
Marketing end 0000-00-00
Substance OMEPRAZOLE
Active strength 20 mg/1
Pharmacologic classes Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC exclude flag E
Listing certified through 2018-12-31
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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075876-001 OMEPRAZOLE OMEPRAZOLE 10MG CAPSULE, DELAYED REL PELLETS / ORAL 2003-05-29 A075876-002 OMEPRAZOLE OMEPRAZOLE 20MG CAPSULE, DELAYED REL PELLETS / ORAL 2003-05-29 A075876-003 OMEPRAZOLE OMEPRAZOLE 40MG CAPSULE, DELAYED REL PELLETS / ORAL 2009-01-21
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 A075876-001 OMEPRAZOLE 10MG CAPSULE, DELAYED REL PELLETS / ORAL 2003-05-29 a50c72e98297…2026-08-01 22:54:32 2026-06 A075876-002 OMEPRAZOLE 20MG CAPSULE, DELAYED REL PELLETS / ORAL 2003-05-29 a50c72e98297…2026-08-01 22:54:32 2026-06 A075876-003 OMEPRAZOLE 40MG CAPSULE, DELAYED REL PELLETS / ORAL 2009-01-21 a50c72e98297…
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 52959-722-15 Omeprazole 15 in 1 BOTTLE CAPSULE, DELAYED RELEASE 15 3 52959-722-20 Omeprazole 20 in 1 BOTTLE CAPSULE, DELAYED RELEASE 20 3 52959-722-30 Omeprazole 30 in 1 BOTTLE CAPSULE, DELAYED RELEASE 30 3 52959-722-60 Omeprazole 60 in 1 BOTTLE CAPSULE, DELAYED RELEASE 60 3 52959-722-90 Omeprazole 90 in 1 BOTTLE CAPSULE, DELAYED RELEASE 90 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OMEPRAZOLE ACTIVE INGREDIENT KG60484QX9 OMEPRAZOLE CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.] 3 OMEPRAZOLE ACTIVE MOIETY KG60484QX9 OMEPRAZOLE CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.] 3 AMMONIA INACTIVE INGREDIENT 5138Q19F1X OMEPRAZOLE CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.] 3 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G OMEPRAZOLE CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.] 3 DIBUTYL SEBACATE INACTIVE INGREDIENT 4W5IH7FLNY OMEPRAZOLE CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.] 3 ETHYLCELLULOSES INACTIVE INGREDIENT 7Z8S9VYZ4B OMEPRAZOLE CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.] 3 FD&C GREEN NO. 3 INACTIVE INGREDIENT 3P3ONR6O1S OMEPRAZOLE CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.] 3 GELATIN INACTIVE INGREDIENT 2G86QN327L OMEPRAZOLE CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO OMEPRAZOLE CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.] 3 METHACRYLIC ACID INACTIVE INGREDIENT 1CS02G8656 OMEPRAZOLE CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.] 3 OLEIC ACID INACTIVE INGREDIENT 2UMI9U37CP OMEPRAZOLE CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 OMEPRAZOLE CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.] 3 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J OMEPRAZOLE CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.] 3 TALC INACTIVE INGREDIENT 7SEV7J4R1U OMEPRAZOLE CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP OMEPRAZOLE CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.] 3 TRIETHYL CITRATE INACTIVE INGREDIENT 8Z96QXD6UM OMEPRAZOLE CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52959-722 OMEPRAZOLE CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.] 3 Legacy NDC, 5 package rows 20120425_8750bc89-340d-4abf-b0b8-b83012ab7cae.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 52959-722-15 52959072215 15 in 1 BOTTLE Historical 52959-722-20 52959072220 20 in 1 BOTTLE Historical 52959-722-30 52959072230 30 in 1 BOTTLE Historical 52959-722-60 52959072260 60 in 1 BOTTLE Historical 52959-722-90 52959072290 90 in 1 BOTTLE Historical