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 6 of 15 · 287 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
omeprazoleOMEPRAZOLEKroger Companyda18d91c-5fe9-44d4-9d6f-602900af3f082025-06-04WarningsName fallback
brand name: omeprazole
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLEP & L Development, LLC44a92926-1941-4fe8-9b2a-31a45289456f2025-06-02WarningsName fallback
brand name: Omeprazole
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLESun Pharmaceutical Industries, Inc.51c3ef34-b7c1-419e-a784-ae82540c7a222025-04-28WarningsName fallback
brand name: Omeprazole
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLEPreferred Pharmaceuticals Inc.0fb314cb-6291-422c-98ff-24d8449992f62025-04-23Warnings, Adverse reactionsName fallback
brand name: Omeprazole
generic name: OMEPRAZOLE
careone omeprazoleOMEPRAZOLERetail Business Services, LLC063cfad8-3ca6-4b72-a4c9-512b8047bae32025-04-17WarningsName fallback
generic name: OMEPRAZOLE
leader omeprazoleOMEPRAZOLECardinal Health 110, LLC. dba Leader19beab17-ca25-4be3-bada-20a2e9aa26b52025-04-16WarningsName fallback
generic name: OMEPRAZOLE
rugby omeprazoleOMEPRAZOLERugby Laboratories61952807-f38d-4e7a-8646-a8ec85d7fb372025-04-15WarningsName fallback
generic name: OMEPRAZOLE
careone omeprazoleOMEPRAZOLEAmerican Sales Companya5ec923a-dbc7-43e0-b3b8-f61dcaa6765d2025-04-14WarningsName fallback
generic name: OMEPRAZOLE
signature care omeprazoleOMEPRAZOLESafeway85ece978-3cfb-4c09-bf0f-3217fda8e7d42025-04-14WarningsName fallback
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLEBI-MARTfb089d15-daa4-477a-be83-ecd55c3283d42025-04-03WarningsName fallback
brand name: Omeprazole
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLEAphena Pharma Solutions - Tennessee, LLCe87d2206-9c06-438c-947b-10b29a879d7b2025-04-03Warnings, Adverse reactionsName fallback
brand name: Omeprazole
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLEAphena Pharma Solutions - Tennessee, LLC2e5d1b21-6b32-0c8d-e063-6294a90a84312025-04-03Warnings, Adverse reactionsName fallback
brand name: Omeprazole
generic name: OMEPRAZOLE
omeprazoleOMEPRAZOLE MAGNESIUMCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED8edfcc08-a14e-4579-bd44-045267de5b792025-04-02WarningsName fallback
brand name: omeprazole
omeprazoleOMEPRAZOLEKroger Company083841e8-482d-4e5b-90ab-1139b576d6912025-03-31WarningsName fallback
brand name: omeprazole
generic name: OMEPRAZOLE
good neighbor pharmacy omeprazoleOMEPRAZOLEAmerisource Bergen54fd9f84-9c67-4846-b79d-eb9e6720a3152025-03-31WarningsName fallback
generic name: OMEPRAZOLE
Signature Care OmeprazoleOMEPRAZOLESafewayc76c4235-92d4-4384-8ddc-ceed0b928c482025-03-31WarningsName fallback
generic name: OMEPRAZOLE
equate omeprazoleOMEPRAZOLEWALMART INC.dcfe8e94-9c88-464e-9a80-3baa9c4755d92025-03-27WarningsName fallback
generic name: OMEPRAZOLE
equate omeprazoleOMEPRAZOLEWal-Mart Stores Inc504b8282-d93f-454f-9f93-84cb8a9105d72025-03-25WarningsName fallback
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLEAllegiant Health3344c589-c4ac-4f2d-8d32-828db4e825a62025-03-19WarningsName fallback
brand name: Omeprazole
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLEAdvanced Rx of Tennessee, LLC30955530-56d2-174d-e063-6294a90a413c2025-03-06Warnings, 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