FDA.reportPublic FDA data

Application 091352

Type
ANDA
Sponsor
ZYDUS PHARMS USA 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
A091352-001OMEPRAZOLEOMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-11-19
A091352-002OMEPRAZOLEOMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-11-19
A091352-003OMEPRAZOLEOMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-11-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A091352-001AB
A091352-002AB
A091352-003AB

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 22:54:322026-06A091352-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-11-19a50c72e98297…
2026-08-01 22:54:322026-06A091352-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-11-19a50c72e98297…
2026-08-01 22:54:322026-06A091352-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-11-19a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A091352-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A091352-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A091352-003AB1a50c72e98297…

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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OmeprazoleOMEPRAZOLEMajor Pharmaceuticalsafda9d2c-b141-4c32-a5b4-e850974b30a32025-09-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091352
application number: ANDA091352
ndc (product): 0904-6917
OmeprazoleOMEPRAZOLECardinal Health 107, LLCfbd71fd8-3f36-46a1-bc76-53f6820d42a22025-06-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091352
application number: ANDA091352
ndc (product): 55154-2332
OmeprazoleOMEPRAZOLEZydus Lifesciences Limited2aaaf0fd-7f2a-4533-b3ad-f35c6c19cca22024-12-03Exact identifier
application applno (ANDA): 091352
application number: ANDA091352
ndc (product): 65841-761
ndc (product): 65841-759
ndc (product): 65841-760
OmeprazoleOMEPRAZOLEA-S Medication Solutions9724601b-bb12-4eb2-bc2e-0532976bf5d12024-07-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091352
application number: ANDA091352
OmeprazoleOMEPRAZOLEA-S Medication Solutions0ef8d55f-6cae-4b58-844b-968d8e5b8c242024-02-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091352
application number: ANDA091352
OmeprazoleOMEPRAZOLEA-S Medication Solutions1c99e189-93c0-4461-82c2-4521e6c4d5142024-02-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091352
application number: ANDA091352
OmeprazoleOMEPRAZOLEBryant Ranch Prepack39e3b45a-8e9b-49d6-976a-6668f4e276492023-07-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091352
application number: ANDA091352
OmeprazoleOMEPRAZOLEZydus Pharmaceuticals USA Inc.9c22ceb2-2c34-43c3-9a35-2589c90787412023-05-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091352
application number: ANDA091352
ndc (product): 68382-500
ndc (product): 68382-411
ndc (product): 68382-412

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 41 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-6917OmeprazoleOmeprazoleMajor PharmaceuticalsANDACurrent
0904-6917OmeprazoleOmeprazoleMajor PharmaceuticalsANDACurrent
0904-6917OmeprazoleOmeprazoleMajor PharmaceuticalsANDACurrent
55154-2332OmeprazoleOmeprazoleCardinal HealthANDACurrent
55154-2332OmeprazoleOmeprazoleCardinal HealthANDACurrent
55154-2332OmeprazoleOmeprazoleCardinal HealthANDACurrent
55154-2332OmeprazoleOmeprazoleCardinal Health 107, LLCANDACurrent
55154-2332OmeprazoleOmeprazoleCardinal HealthANDACurrent
65841-759OmeprazoleOmeprazoleCadila Healthcare LimitedANDACurrent
65841-759OmeprazoleOmeprazoleCadila Healthcare LimitedANDACurrent
65841-759OmeprazoleOmeprazoleZydus Lifesciences LimitedANDACurrent
65841-759OmeprazoleOmeprazoleCadila Healthcare LimitedANDACurrent
65841-760OmeprazoleOmeprazoleCadila Healthcare LimitedANDACurrent
65841-760OmeprazoleOmeprazoleCadila Healthcare LimitedANDACurrent
65841-760OmeprazoleOmeprazoleZydus Lifesciences LimitedANDACurrent
65841-760OmeprazoleOmeprazoleCadila Healthcare LimitedANDACurrent
65841-761OmeprazoleOmeprazoleCadila Healthcare LimitedANDACurrent
65841-761OmeprazoleOmeprazoleCadila Healthcare LimitedANDACurrent
65841-761OmeprazoleOmeprazoleZydus Lifesciences LimitedANDACurrent
65841-761OmeprazoleOmeprazoleCadila Healthcare LimitedANDACurrent
68382-411OmeprazoleOmeprazoleZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-411OmeprazoleOmeprazoleZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-411OmeprazoleOmeprazoleZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-411OmeprazoleOmeprazoleZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-411OmeprazoleOmeprazoleZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-411OmeprazoleOmeprazoleZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-411OmeprazoleOmeprazoleZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-412OmeprazoleOmeprazoleZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-412OmeprazoleOmeprazoleZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-412OmeprazoleOmeprazoleZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-412OmeprazoleOmeprazoleZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-412OmeprazoleOmeprazoleZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-412OmeprazoleOmeprazoleZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-412OmeprazoleOmeprazoleZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-500OmeprazoleOmeprazoleZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-500OmeprazoleOmeprazoleZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-500OmeprazoleOmeprazoleZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-500OmeprazoleOmeprazoleZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-500OmeprazoleOmeprazoleZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-500OmeprazoleOmeprazoleZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-500OmeprazoleOmeprazoleZydus Pharmaceuticals (USA) Inc.ANDACurrent