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 9 of 15 · 287 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Good Sense OmeprazoleOMEPRAZOLEL. Perrigo Company11dfbf6c-59bf-4a30-b627-f49ccd31c0d02024-12-19WarningsName fallback
generic name: OMEPRAZOLE
basic care omeprazoleOMEPRAZOLEAmazon.com Services LLC548629d3-8d93-465d-b6ac-2a42bc0baebf2024-12-19WarningsName fallback
generic name: OMEPRAZOLE
exchange select omeprazoleOMEPRAZOLEArmy & Air Force Exchange Service22b4492d-7afe-410f-97bf-57e4a57b1c272024-12-19WarningsName fallback
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLEDr. Reddys Laboratories Inc4b3b389d-a151-d851-cb05-64eb49979e5e2024-12-19WarningsName fallback
brand name: Omeprazole
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLEA-S Medication Solutions59d8be3f-ba13-4897-9ceb-f8ac6ccc16242024-12-16Warnings, Adverse reactionsName fallback
brand name: Omeprazole
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLEA-S Medication Solutions487ff32f-943e-458b-b898-bd7b0290cc492024-12-16Warnings, Adverse reactionsName fallback
brand name: Omeprazole
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLEQuality Care Products, LLC581d1c3d-457a-41f2-8db0-5b6219cdcb092024-12-16Warnings, Adverse reactionsName fallback
brand name: Omeprazole
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLEA-S Medication Solutionsc8f2e604-74fa-4205-b41f-32401e2dc59e2024-12-16Warnings, Adverse reactionsName fallback
brand name: Omeprazole
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLEBryant Ranch Prepack064b1418-0f42-4b18-9dee-cda40c5e1fca2024-12-11Warnings, Adverse reactionsName fallback
brand name: Omeprazole
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLEBryant Ranch Prepackc311c1b9-8ec2-4ac0-baa2-a5063fba2d802024-12-11Warnings, Adverse reactionsName fallback
brand name: Omeprazole
generic name: OMEPRAZOLE
Equate omeprazole delayed release acid reducerOMEPRAZOLEWal-Mart Stores Inc9a0f2d8a-eaad-403b-90c3-0fd275abe4dc2024-12-08WarningsName fallback
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLEZydus Lifesciences Limited2aaaf0fd-7f2a-4533-b3ad-f35c6c19cca22024-12-03Name fallback
brand name: Omeprazole
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLEProficient Rx LPee0598a1-0e5e-40ff-ad88-b0adfc533ca02024-12-01Warnings, Adverse reactionsName fallback
brand name: Omeprazole
generic name: OMEPRAZOLE
Leader OmeprazoleOMEPRAZOLECardinal Health 110, LLC. dba Leaderb2dd3c63-3875-4a9b-9b78-b5b3eba2aa1a2024-11-26WarningsName fallback
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLEGERI-CARE PHARMACEUTICALS, CORP8a77aea7-912e-43a3-bce3-f666b9b9c9bc2024-11-22WarningsName fallback
brand name: Omeprazole
generic name: OMEPRAZOLE
foster and thrive omeprazoleOMEPRAZOLEStrategic Sourcing Services LLC51bcc19d-acfc-487b-870b-251c8953741f2024-11-20WarningsName fallback
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLERising Pharma Holdings, Inc.a1b1c61b-d4fe-433d-ad31-0b11758976fa2024-11-12Warnings, Adverse reactionsName fallback
brand name: Omeprazole
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLEWalgreens Company5e2994fc-8f44-f6e4-71fe-44a215aa93a92024-11-10WarningsName fallback
brand name: Omeprazole
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLEDr. Reddys Laboratories Incb377cb0b-14b2-04bb-f276-fd69a257f9ca2024-11-10WarningsName fallback
brand name: Omeprazole
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLEBryant Ranch Prepack1249c42d-6358-48b3-8fe0-10333c7f501d2024-10-31Warnings, 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