Home NDC 0615-1359 Omeprazole
Product NDC 0615-1359
11-digit product format 006151359
Labeler code 0615
Product ID 0615-1359_d8c173e5-5cd0-4243-8599-e9fc0bd57acc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Omeprazole
Dosage form CAPSULE, DELAYED RELEASE
Route ORAL
Labeler NCS HealthCare of KY, Inc dba Vangard Labs
Application ANDA075757
Marketing category ANDA
Marketing start 2003-01-28
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 2017-12-31
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075757-001 OMEPRAZOLE OMEPRAZOLE 10MG CAPSULE, DELAYED REL PELLETS / ORAL AB 2003-01-28 A075757-002 OMEPRAZOLE OMEPRAZOLE 20MG CAPSULE, DELAYED REL PELLETS / ORAL AB 2003-01-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 A075757-001 OMEPRAZOLE 10MG CAPSULE, DELAYED REL PELLETS / ORAL AB 2003-01-28 a50c72e98297…2026-08-01 22:54:32 2026-06 A075757-002 OMEPRAZOLE 20MG CAPSULE, DELAYED REL PELLETS / ORAL AB 2003-01-28 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 A075757-001 AB 1 a50c72e98297…2026-08-01 22:54:32 2026-06 A075757-002 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 · 9 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Omeprazole OMEPRAZOLE St. Mary's Medical Park Pharmacy db9f071b-85f4-061f-e053-2995a90a3ff5 2026-06-26 Warnings, Adverse reactions Exact identifier application applno (ANDA): 075757 application number: ANDA075757 Omeprazole OMEPRAZOLE QPharma Inc f6f6ad19-ff6a-7cd3-e053-6294a90ae1bf 2026-05-11 Warnings, Adverse reactions Exact identifier application applno (ANDA): 075757 application number: ANDA075757 Omeprazole OMEPRAZOLE Northwind Health Company, LLC f76c23d5-26b6-cfb2-e053-6294a90aea42 2026-01-01 Warnings, Adverse reactions Exact identifier application applno (ANDA): 075757 application number: ANDA075757 Omeprazole OMEPRAZOLE Preferred Pharmaceuticals Inc. 0fb314cb-6291-422c-98ff-24d8449992f6 2025-04-23 Warnings, Adverse reactions Exact identifier application applno (ANDA): 075757 application number: ANDA075757 Omeprazole OMEPRAZOLE Chartwell RX, LLC 4b1a6f05-ae3e-4f29-bc2d-8e9f51e5fe3e 2025-02-12 Warnings, Adverse reactions Exact identifier application applno (ANDA): 075757 application number: ANDA075757 Omeprazole OMEPRAZOLE Sandoz Inc 516170d4-4913-4577-a2d2-f5c52d1e79c6 2024-12-31 Warnings, Adverse reactions Exact identifier application applno (ANDA): 075757 application number: ANDA075757 Omeprazole OMEPRAZOLE Proficient Rx LP ee0598a1-0e5e-40ff-ad88-b0adfc533ca0 2024-12-01 Warnings, Adverse reactions Exact identifier application applno (ANDA): 075757 application number: ANDA075757 Omeprazole OMEPRAZOLE Bryant Ranch Prepack 17664f71-154a-47c6-b83c-b349bbc8a98f 2024-08-08 Warnings, Adverse reactions Exact identifier application applno (ANDA): 075757 application number: ANDA075757 Omeprazole OMEPRAZOLE Sandoz Inc e4562da8-9d94-4417-9f80-c1ffd4247259 2023-04-30 Warnings, Adverse reactions Exact identifier application applno (ANDA): 075757 application number: ANDA075757
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Action table NDC Effective Action Document Indexing SPL Related label 0615-1359-05 2022-10-26 C162847 48780-1 9d75b9d0-8653-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use omeprazole delayed-release capsules safely and effectively. See full prescribing information for omeprazole delayed-release capsules Omeprazole delayed-release capsules, USP, for oral administration Initial U.S. Approval: 1989 0615-1359-31 2022-10-26 C162847 48780-1 9d75b9d0-8653-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use omeprazole delayed-release capsules safely and effectively. See full prescribing information for omeprazole delayed-release capsules Omeprazole delayed-release capsules, USP, for oral administration Initial U.S. Approval: 1989 0615-1359-39 2022-10-26 C162847 48780-1 9d75b9d0-8653-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use omeprazole delayed-release capsules safely and effectively. See full prescribing information for omeprazole delayed-release capsules Omeprazole delayed-release capsules, USP, for oral administration Initial U.S. Approval: 1989 0615-1359-05 2020-01-31 C162847 48780-1 9d75b9d0-8653-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use omeprazole delayed-release capsules safely and effectively. See full prescribing information for omeprazole delayed-release capsules Omeprazole delayed-release capsules, USP, for oral administration Initial U.S. Approval: 1989 0615-1359-31 2020-01-31 C162847 48780-1 9d75b9d0-8653-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use omeprazole delayed-release capsules safely and effectively. See full prescribing information for omeprazole delayed-release capsules Omeprazole delayed-release capsules, USP, for oral administration Initial U.S. Approval: 1989 0615-1359-39 2020-01-31 C162847 48780-1 9d75b9d0-8653-f424-e053-dadaa90a57ce These highlights do not include all the information needed to use omeprazole delayed-release capsules safely and effectively. See full prescribing information for omeprazole delayed-release capsules Omeprazole delayed-release capsules, USP, for oral administration Initial U.S. Approval: 1989
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OMEPRAZOLE ACTIVE INGREDIENT KG60484QX9 OMEPRAZOLE CAPSULE, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 12 OMEPRAZOLE ACTIVE MOIETY KG60484QX9 OMEPRAZOLE CAPSULE, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 12 ACETONE INACTIVE INGREDIENT 1364PS73AF OMEPRAZOLE CAPSULE, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 12 ALCOHOL INACTIVE INGREDIENT 3K9958V90M OMEPRAZOLE CAPSULE, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 12 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK OMEPRAZOLE CAPSULE, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 12 CARRAGEENAN INACTIVE INGREDIENT 5C69YCD2YJ OMEPRAZOLE CAPSULE, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 12 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U OMEPRAZOLE CAPSULE, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 12 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 OMEPRAZOLE CAPSULE, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 12 DIBUTYL SEBACATE INACTIVE INGREDIENT 4W5IH7FLNY OMEPRAZOLE CAPSULE, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 12 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 OMEPRAZOLE CAPSULE, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 12 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P OMEPRAZOLE CAPSULE, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 12 HYPROMELLOSE 2208 (100 MPA.S) INACTIVE INGREDIENT B1QE5P712K OMEPRAZOLE CAPSULE, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 12 HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST) INACTIVE INGREDIENT 87Y6436BKR OMEPRAZOLE CAPSULE, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 12 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H OMEPRAZOLE CAPSULE, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 12 POTASSIUM CHLORIDE INACTIVE INGREDIENT 660YQ98I10 OMEPRAZOLE CAPSULE, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 12 POVIDONES INACTIVE INGREDIENT FZ989GH94E OMEPRAZOLE CAPSULE, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 12 TALC INACTIVE INGREDIENT 7SEV7J4R1U OMEPRAZOLE CAPSULE, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 12 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP OMEPRAZOLE CAPSULE, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 12