FDA.reportPublic FDA data

Application 075410

Type
ANDA
Sponsor
LANNETT CO INC

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
A075410-001OMEPRAZOLEOMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2002-11-01
A075410-002OMEPRAZOLEOMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2002-11-01
A075410-003OMEPRAZOLEOMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A075410-001AB
A075410-002AB
A075410-003AB

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 22:54:322026-06A075410-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2002-11-01a50c72e98297…
2026-08-01 22:54:322026-06A075410-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2002-11-01a50c72e98297…
2026-08-01 22:54:322026-06A075410-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-23a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A075410-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A075410-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A075410-003AB1a50c72e98297…

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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OmeprazoleOMEPRAZOLEChartwell RX, LLC10f5502a-2e63-4f2a-a3ba-ddc5bd4030512025-12-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075410
application number: ANDA075410
OmeprazoleOMEPRAZOLEPD-Rx Pharmaceuticals, Inc.ed9895ae-3d18-434c-8b56-47bccdc8fe6d2025-10-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075410
application number: ANDA075410
OmeprazoleOMEPRAZOLENuCare Pharmaceuticals,Inc.ad675ef6-5377-b9f2-e053-2995a90a06e92024-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075410
application number: ANDA075410
ndc (product): 68071-2243
OmeprazoleOMEPRAZOLENuCare Pharmaceuticals,Inc.55a1fb3c-f040-2e39-e054-00144ff8d46c2024-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075410
application number: ANDA075410
ndc (product): 68071-4025
OmeprazoleOMEPRAZOLENuCare Pharmaceuticals,Inc.8991d464-7abc-4350-e053-2995a90a4ea72024-06-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075410
application number: ANDA075410
OmeprazoleOMEPRAZOLEBryant Ranch Prepack1318a1c1-222d-471a-92d6-3632c82fb9992024-05-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075410
application number: ANDA075410
OmeprazoleOMEPRAZOLEBryant Ranch Prepack18f5a7cc-40d8-4aeb-a601-47bc9024f1302024-05-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075410
application number: ANDA075410
OmeprazoleOMEPRAZOLELannett Company, Inc.92201fb1-4570-42db-8da3-3b8c0e291d322023-04-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075410
application number: ANDA075410
ndc (product): 62175-136
ndc (product): 62175-118
ndc (product): 62175-114
OmeprazoleOMEPRAZOLEProficient Rx LP9786b04f-f827-460b-91bc-c0ac967f95dd2022-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075410
application number: ANDA075410
OmeprazoleOMEPRAZOLEAphena Pharma Solutions - Tennessee, LLC4b188d97-f1b3-468d-9818-b8333bf24b5a2020-12-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075410
application number: ANDA075410
ndc (product): 43353-829

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 121 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16853-1308OMESECOmeprazoleCorporacion InfarmasaANDACurrent
21695-097OmeprazoleomeprazoleRebel Distributors Corp.ANDACurrent
21695-098OmeprazoleomeprazoleRebel Distributors Corp.ANDACurrent
35356-644OmeprazoleomeprazoleLake Erie Medical DBA Quality Care Products LLCANDACurrent
43353-829OmeprazoleomeprazoleAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-829OmeprazoleomeprazoleAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-829OmeprazoleomeprazoleAphena Pharma Solutions - Tennessee, LLCANDACurrent
50090-0828OmeprazoleomeprazoleA-S Medication SolutionsANDACurrent
50090-0828OmeprazoleomeprazoleA-S Medication SolutionsANDACurrent
50090-1370OmeprazoleomeprazoleA-S Medication SolutionsANDACurrent
50090-1370OmeprazoleomeprazoleA-S Medication SolutionsANDACurrent
50090-1370OmeprazoleomeprazoleA-S Medication SolutionsANDACurrent
50090-1370OmeprazoleomeprazoleA-S Medication SolutionsANDACurrent
50090-4595OmeprazoleomeprazoleA-S Medication SolutionsANDACurrent
50090-4907OmeprazoleomeprazoleA-S Medication SolutionsANDACurrent
50090-4907OmeprazoleomeprazoleA-S Medication SolutionsANDACurrent
50090-5054OmeprazoleomeprazoleA-S Medication SolutionsANDACurrent
50090-5054OmeprazoleomeprazoleA-S Medication SolutionsANDACurrent
50268-619OmeprazoleomeprazoleAvPAKANDACurrent
50268-619OmeprazoleomeprazoleAvPAKANDACurrent
50268-620OmeprazoleomeprazoleAvPAKANDACurrent
50268-620OmeprazoleomeprazoleAvPAKANDACurrent
50436-3125OmeprazoleomeprazoleUnit Dose ServicesANDACurrent
51407-256OmeprazoleomeprazoleGolden State Medical SupplyANDACurrent
51407-256OmeprazoleomeprazoleGolden State Medical SupplyANDACurrent
51407-256OmeprazoleomeprazoleGolden State Medical SupplyANDACurrent
51407-256OmeprazoleomeprazoleGolden State Medical Supply, Inc.ANDACurrent
51407-256OmeprazoleomeprazoleGolden State Medical Supply, Inc.ANDACurrent
51407-303OmeprazoleomeprazoleGolden State Medical SupplyANDACurrent
51407-303OmeprazoleomeprazoleGolden State Medical SupplyANDACurrent
51407-303OmeprazoleomeprazoleGolden State Medical SupplyANDACurrent
51407-303OmeprazoleomeprazoleGolden State Medical Supply, Inc.ANDACurrent
51407-303OmeprazoleomeprazoleGolden State Medical Supply, Inc.ANDACurrent
53002-2688OmeprazoleomeprazoleRPK Pharmaceuticals, Inc.ANDACurrent
53217-353OmeprazoleomeprazoleAidarex Pharmaceuticals LLCANDACurrent
60760-395OmeprazoleomeprazoleSt. Mary's Medical Park PharmacyANDACurrent
60760-489OmeprazoleomeprazoleSt. Mary's Medical Park PharmacyANDACurrent
60760-489OmeprazoleomeprazoleSt. Mary's Medical Park PharmacyANDACurrent
62175-114OmeprazoleomeprazoleLannett Company, Inc.ANDACurrent
62175-114OmeprazoleomeprazoleLannett Company, Inc.ANDACurrent
62175-114OmeprazoleomeprazoleLannett Company, Inc.ANDACurrent
62175-114OmeprazoleomeprazoleLannett Company, Inc.ANDACurrent
62175-114OmeprazoleomeprazoleLannett Company, Inc.ANDACurrent
62175-114OmeprazoleomeprazoleLannett Company, Inc.ANDACurrent
62175-114OmeprazoleomeprazoleLannett Company, Inc.ANDACurrent
62175-114OmeprazoleomeprazoleLannett Company, Inc..ANDACurrent
62175-118OmeprazoleomeprazoleLannett Company, Inc.ANDACurrent
62175-118OmeprazoleomeprazoleLannett Company, Inc.ANDACurrent
62175-118OmeprazoleomeprazoleLannett Company, Inc.ANDACurrent
62175-118OmeprazoleomeprazoleLannett Company, Inc.ANDACurrent
62175-118OmeprazoleomeprazoleLannett Company, Inc.ANDACurrent
62175-118OmeprazoleomeprazoleLannett Company, Inc.ANDACurrent
62175-118OmeprazoleomeprazoleLannett Company, Inc.ANDACurrent
62175-118OmeprazoleomeprazoleLannett Company, Inc..ANDACurrent
62175-136OmeprazoleomeprazoleLannett Company, Inc.ANDACurrent
62175-136OmeprazoleomeprazoleLannett Company, Inc.ANDACurrent
62175-136OmeprazoleomeprazoleLannett Company, Inc.ANDACurrent
62175-136OmeprazoleomeprazoleLannett Company, Inc.ANDACurrent
62175-136OmeprazoleomeprazoleLannett Company, Inc.ANDACurrent
62175-136OmeprazoleomeprazoleLannett Company, Inc.ANDACurrent
62175-136OmeprazoleomeprazoleLannett Company, Inc.ANDACurrent
62175-136OmeprazoleomeprazoleLannett Company, Inc..ANDACurrent
63739-358OmeprazoleomeprazoleMcKesson Corporation dba SKY PackagingANDACurrent
63739-358OmeprazoleomeprazoleMcKesson Corporation dba SKY PackagingANDACurrent
63739-358OmeprazoleomeprazoleMcKesson CorporationANDACurrent
63739-445OmeprazoleomeprazoleMcKesson Corporation dba SKY PackagingANDACurrent
63739-445OmeprazoleomeprazoleMcKesson Corporation dba SKY PackagingANDACurrent
63739-445OmeprazoleomeprazoleMcKesson CorporationANDACurrent
63874-553OmeprazoleomeprazoleAltura Pharmaceuticals, Inc.ANDACurrent
65084-445OmeprazoleomeprazoleMcKesson Corporation dba RX PakANDACurrent
67046-520OmeprazoleOmeprazoleContract Pharmacy Services-PAANDACurrent
67544-510OmeprazoleomeprazoleAphena Pharma Solutions - Tennessee, LLCANDACurrent
67544-510OmeprazoleomeprazoleAphena Pharma Solutions - Tennessee, LLCANDACurrent
68071-2243OmeprazoleomeprazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2243OmeprazoleomeprazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2358OmeprazoleomeprazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2499OmeprazoleomeprazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4025OmeprazoleomeprazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4025OmeprazoleomeprazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4140OmeprazoleomeprazoleNuCare Pharmaceuticals,Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
42992ORIG2005-07-22
8657ORIG2004-06-28