FDA.reportPublic FDA data

Application 075876

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OMEPRAZOLEOMEPRAZOLECAPSULE, DELAYED REL PELLETS;ORAL10MGNoNo
002OMEPRAZOLEOMEPRAZOLECAPSULE, DELAYED REL PELLETS;ORAL20MGNoNo
003OMEPRAZOLEOMEPRAZOLECAPSULE, DELAYED REL PELLETS;ORAL40MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075876-001OMEPRAZOLEOMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORAL2003-05-29
A075876-002OMEPRAZOLEOMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORAL2003-05-29
A075876-003OMEPRAZOLEOMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORAL2009-01-21

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.

Product history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A075876-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORAL2003-05-2984e616aacf4f…
2026-09-14 22:38:342026-08A075876-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORAL2003-05-2984e616aacf4f…
2026-09-14 22:38:342026-08A075876-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORAL2009-01-2184e616aacf4f…
2026-08-18 06:07:402026-07A075876-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORAL2003-05-29caaa826d4ba7…
2026-08-18 06:07:402026-07A075876-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORAL2003-05-29caaa826d4ba7…
2026-08-18 06:07:402026-07A075876-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORAL2009-01-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075876-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORAL2003-05-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075876-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORAL2003-05-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075876-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORAL2009-01-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075876-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORAL2003-05-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075876-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORAL2003-05-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075876-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORAL2009-01-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075876-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORAL2003-05-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075876-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORAL2003-05-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075876-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORAL2009-01-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075876-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORAL2003-05-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075876-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORAL2003-05-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075876-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORAL2009-01-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075876-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORAL2003-05-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075876-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORAL2003-05-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075876-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORAL2009-01-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075876-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORAL2003-05-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075876-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORAL2003-05-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075876-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORAL2009-01-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075876-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORAL2003-05-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075876-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORAL2003-05-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075876-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORAL2009-01-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075876-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORAL2003-05-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075876-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORAL2003-05-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075876-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORAL2009-01-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075876-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORAL2003-05-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075876-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORAL2003-05-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075876-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORAL2009-01-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075876-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORAL2003-05-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A075876-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORAL2003-05-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A075876-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORAL2009-01-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075876-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORAL2003-05-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075876-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORAL2003-05-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075876-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORAL2009-01-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075876-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORAL2003-05-29301d65b070ca…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A075876-002AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A075876-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A075876-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A075876-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A075876-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A075876-003AB1ea99ee380514…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 7 of 15 · 287 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OmeprazoleOMEPRAZOLECVS Pharmacy01bde9ca-0114-426d-8188-c55aefaa09612025-03-05WarningsName fallback
brand name: Omeprazole
generic name: OMEPRAZOLE
omeprazoleOMEPRAZOLEH E B501d80c0-68ee-4fd9-bc56-0b214dbf72b52025-02-27WarningsName fallback
brand name: omeprazole
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLEAphena Pharma Solutions - Tennessee, LLC40f66cac-bc23-43f9-9966-87cce458c9962025-02-17Warnings, Adverse reactionsName fallback
brand name: Omeprazole
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLEAsclemed USA, Inc.9c41bcfa-b08b-3ac3-e053-2a95a90ae1c02025-02-13Warnings, Adverse reactionsName fallback
brand name: Omeprazole
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLEChartwell RX, LLC4b1a6f05-ae3e-4f29-bc2d-8e9f51e5fe3e2025-02-12Warnings, Adverse reactionsName fallback
brand name: Omeprazole
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLEAphena Pharma Solutions - Tennessee, LLC2dcd48e4-9ffc-9cc2-e063-6294a90ae17e2025-02-10Warnings, Adverse reactionsName fallback
brand name: Omeprazole
generic name: OMEPRAZOLE
omeprazoleOMEPRAZOLEPadagis Israel Pharmaceuticals Ltdcb47354c-297b-4dc2-85af-242acc967b562025-02-06WarningsName fallback
brand name: omeprazole
generic name: OMEPRAZOLE
Signature Care OmeprazoleOMEPRAZOLESafeway6361a492-782f-4608-a20f-1bd86afbd8642025-02-06WarningsName fallback
generic name: OMEPRAZOLE
omeprazoleOMEPRAZOLEH E B5ceaec04-3ca3-4c7c-9184-51a42686a5952025-02-05WarningsName fallback
brand name: omeprazole
generic name: OMEPRAZOLE
kirkland signature omeprazoleOMEPRAZOLECostco Wholesale Company48a44d0c-3502-430b-8b75-188a49d14da22025-02-05WarningsName fallback
generic name: OMEPRAZOLE
omeprazoleOMEPRAZOLEMeijer Distribution Inc925399c7-dcbc-4546-9111-2a98a11ba5382025-02-05WarningsName fallback
brand name: omeprazole
generic name: OMEPRAZOLE
topcare omeprazoleOMEPRAZOLETopco Associates LLC436c5ea1-c5ee-481f-803d-439f65873b1c2025-01-31WarningsName fallback
generic name: OMEPRAZOLE
up and up omeprazoleOMEPRAZOLETarget Corporation8f2eb5e8-80f2-4c40-a8ad-e1d9c10d0c562025-01-31WarningsName fallback
generic name: OMEPRAZOLE
DG health omperazoleOMEPRAZOLEDolgencorp Inc99fdfeed-6828-4bf6-bb81-cd29a4ec610b2025-01-31WarningsName fallback
generic name: OMEPRAZOLE
omeprazoleOMEPRAZOLEH E B344b5548-e5c0-45bf-bc3f-73af50bd59132025-01-30WarningsName fallback
brand name: omeprazole
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLECoupler LLC2cdc6809-3b1b-046a-e063-6394a90ae02a2025-01-29Warnings, Adverse reactionsName fallback
brand name: Omeprazole
generic name: OMEPRAZOLE
Basic Care OmeprazoleOMEPRAZOLEAmazon.com Services LLC87a2aa9b-c681-41c7-8a59-b359efd443cb2025-01-22WarningsName fallback
generic name: OMEPRAZOLE
good sense omeprazoleOMEPRAZOLEL. Perrigo Companydcd93796-8904-415d-a379-c4ea590cf5442025-01-22WarningsName fallback
generic name: OMEPRAZOLE
omeprazoleOMEPRAZOLEWalgreen Company064f048c-eddd-4370-9ee4-706f9f00c8d22025-01-22WarningsName fallback
brand name: omeprazole
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLEPreferred Pharmaceuticals Inc.a806da8c-5f84-454d-966c-da1c48710f802025-01-20Warnings, Adverse reactionsName fallback
brand name: Omeprazole
generic name: OMEPRAZOLE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-5211OmeprazoleomeprazoleMylan Pharmaceuticals Inc.ANDACurrent
0378-5222OmeprazoleomeprazoleMylan Pharmaceuticals Inc.ANDACurrent
0378-6150OmeprazoleomeprazoleMylan Pharmaceuticals Inc.ANDACurrent
10544-295OmeprazoleomeprazoleBlenheim Pharmacal, Inc.ANDACurrent
10544-299OmeprazoleomeprazoleBlenheim Pharmacal, Inc.ANDACurrent
35356-811OmeprazoleOmeprazoleLake Erie Medical DBA Quality Care Products LLCANDACurrent
51079-007OmeprazoleomeprazoleMylan Institutional Inc.ANDACurrent
52959-722OmeprazoleOmeprazoleH.J. Harkins Company, Inc.ANDACurrent
53808-0746OmeprazoleomeprazoleState of Florida DOH Central PharmacyANDACurrent
55154-5681OmeprazoleomeprazoleCardinal HealthANDACurrent
60429-270OmeprazoleomeprazoleGolden State Medical Supply, Inc.ANDACurrent
60429-270OmeprazoleomeprazoleGolden State Medical Supply, Inc.ANDACurrent
60429-270OmeprazoleomeprazoleGolden State Medical Supply, Inc.ANDACurrent
60429-271OmeprazoleomeprazoleGolden State Medical Supply, Inc.ANDACurrent
60429-271OmeprazoleomeprazoleGolden State Medical Supply, Inc.ANDACurrent
63629-2607OmeprazoleomeprazoleBryant Ranch PrepackANDACurrent
63629-2607OmeprazoleomeprazoleBryant Ranch PrepackANDACurrent
66336-706OmeprazoleomeprazoleDispensing Solutions, Inc.ANDACurrent