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 1.

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A075876-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORAL2003-05-29a50c72e98297…
2026-08-01 22:54:322026-06A075876-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORAL2003-05-29a50c72e98297…
2026-08-01 22:54:322026-06A075876-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORAL2009-01-21a50c72e98297…

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 15 · 287 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OmeprazoleOMEPRAZOLEREMEDYREPACK INC.a19ce586-59b7-4c2e-9e8d-12e8f0f058e22026-07-21Warnings, Adverse reactionsName fallback
brand name: Omeprazole
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLEPD-Rx Pharmaceuticals, Inc.0344268f-d8e6-48d5-b1e1-f750ed1d8a522026-07-17Warnings, Adverse reactionsName fallback
brand name: Omeprazole
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLEP & L Development, LLC883e428a-e157-4bbf-8657-e7a93dc99e8c2026-07-14WarningsName fallback
brand name: Omeprazole
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLEWALMART INC. (see also Equate)d3c1ba08-680d-4e39-875c-1f1d42ae787c2026-07-13WarningsName fallback
brand name: Omeprazole
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLEHAWAII REPACK, INC.9359e826-5263-44fc-8dd3-9d0852fe42d62026-07-13Warnings, Adverse reactionsName fallback
brand name: Omeprazole
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLEBryant Ranch Prepackdcaadc8c-32d1-476f-b821-973c012b7fa72026-07-10Warnings, Adverse reactionsName fallback
brand name: Omeprazole
generic name: OMEPRAZOLE
careone omeprazoleOMEPRAZOLEAmerican Sales Company5b88717a-e90c-4e74-ae2a-29270e14a3cc2026-07-08WarningsName fallback
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLESt. Mary's Medical Park Pharmacy4c0cf466-f9e8-390e-e063-6294a90a2ed82026-07-02Warnings, Adverse reactionsName fallback
brand name: Omeprazole
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLEUnit Dose Solutions, Inc.557d4c2c-5541-3a51-e063-6394a90ad2782026-06-30Warnings, Adverse reactionsName fallback
brand name: Omeprazole
generic name: OMEPRAZOLE
GOOD SENSE OMEPRAZOLEOMEPRAZOLEL. Perrigo Companyb840439b-540b-465a-8faa-f7b1024c628e2026-06-29WarningsName fallback
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLEPLD Acquisitions LLC DBA Avma Pharma Solutionsd9c8a242-bdba-4f92-8629-692b47ebba212026-06-26WarningsName fallback
brand name: Omeprazole
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLEPLD Acquisitions LLC DBA Avma Pharma Solutions71add294-ff24-4bbf-9067-7c56ed7c9f1a2026-06-26WarningsName fallback
brand name: Omeprazole
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLEPLD Acquisitions LLC DBA Avma Pharma Solutionse67bf2c6-0618-48e0-aa08-705501d864312026-06-26WarningsName fallback
brand name: Omeprazole
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLESt. Mary's Medical Park Pharmacydb9f071b-85f4-061f-e053-2995a90a3ff52026-06-26Warnings, Adverse reactionsName fallback
brand name: Omeprazole
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLEPLD Acquisitions LLC DBA Avma Pharma Solutions6a1aeb95-5760-4363-816a-fa8305979c502026-06-26WarningsName fallback
brand name: Omeprazole
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLEP & L Development, LLC911a08c4-ba73-4600-a5f2-7f26ba8c86042026-06-25WarningsName fallback
brand name: Omeprazole
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLEREMEDYREPACK INC.d9b3918c-a66e-4277-8b8f-b7ece93fa7db2026-06-24Warnings, Adverse reactionsName fallback
brand name: Omeprazole
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLESt. Mary's Medical Park Pharmacy1eb57c13-25ed-70bc-e063-6294a90afdac2026-06-10Warnings, Adverse reactionsName fallback
brand name: Omeprazole
generic name: OMEPRAZOLE
OmeprazoleOMEPRAZOLEQPharma Inc50115204-74f7-17c1-e063-6394a90ab6652026-06-08Warnings, Adverse reactionsName fallback
brand name: Omeprazole
generic name: OMEPRAZOLE
Acid ReducerOMEPRAZOLEINNOVUS PHARMACEUTICALS, INC.a4e92bd2-8f75-4acc-9b75-df8332bd4cc42026-06-04WarningsName fallback
generic name: OMEPRAZOLE

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