FDA.reportPublic FDA data

Application 091672

Type
ANDA
Sponsor
GLENMARK GENERICS

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
A091672-001OMEPRAZOLEOMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2014-10-31
A091672-002OMEPRAZOLEOMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALABRS2014-10-31
A091672-003OMEPRAZOLEOMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALABRS2014-10-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A091672-001AB
A091672-002AB
A091672-003AB

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 22:54:322026-06A091672-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2014-10-31a50c72e98297…
2026-08-01 22:54:322026-06A091672-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALABRS2014-10-31a50c72e98297…
2026-08-01 22:54:322026-06A091672-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALABRS2014-10-31a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A091672-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A091672-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A091672-003AB1a50c72e98297…

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 2 · 27 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OmeprazoleOMEPRAZOLEREMEDYREPACK INC.a19ce586-59b7-4c2e-9e8d-12e8f0f058e22026-07-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091672
application number: ANDA091672
OmeprazoleOMEPRAZOLEHAWAII REPACK, INC.9359e826-5263-44fc-8dd3-9d0852fe42d62026-07-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091672
application number: ANDA091672
OmeprazoleOMEPRAZOLEBryant Ranch Prepackdcaadc8c-32d1-476f-b821-973c012b7fa72026-07-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091672
application number: ANDA091672
OmeprazoleOMEPRAZOLEUnit Dose Solutions, Inc.557d4c2c-5541-3a51-e063-6394a90ad2782026-06-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091672
application number: ANDA091672
OmeprazoleOMEPRAZOLEREMEDYREPACK INC.d9b3918c-a66e-4277-8b8f-b7ece93fa7db2026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091672
application number: ANDA091672
OmeprazoleOMEPRAZOLEST. MARY'S MEDICAL PARK PHARMACY4f5c91e6-6377-ca94-e063-6294a90a2f992026-04-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091672
application number: ANDA091672
Omeprazole DROMEPRAZOLEAdvanced Rx Pharmacy of Tennessee, LLCc8bf92c9-1bab-7985-e053-2995a90a02252026-03-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091672
application number: ANDA091672
OmeprazoleOMEPRAZOLEGlenmark Pharmaceuticals Inc., USAc6c22be1-659d-4e71-b292-701e27da201b2026-01-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091672
application number: ANDA091672
ndc (product): 68462-396
ndc (product): 68462-397
ndc (product): 68462-395
OmeprazoleOMEPRAZOLEPreferred Pharmaceuticals Inc.fa0395a7-4353-4d64-9de8-d15857a7031c2026-01-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091672
application number: ANDA091672
OmeprazoleOMEPRAZOLEA-S Medication Solutions17ccdbe0-19c1-498d-8e81-578be549b4e52025-12-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091672
application number: ANDA091672
ndc (product): 50090-5111
OmeprazoleOMEPRAZOLEPreferred Pharmaceuticals Inc.aa8fc2ea-3942-453b-bc19-1e4b14ba69262025-09-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091672
application number: ANDA091672
ndc (product): 68788-6881
OmeprazoleOMEPRAZOLEAphena Pharma Solutions - Tennessee, LLC3d6e07d1-38b1-f2ab-e063-6294a90a34ac2025-08-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091672
application number: ANDA091672
OmeprazoleOMEPRAZOLEAphena Pharma Solutions - Tennessee, LLCbab55f83-ba03-49a0-842a-19c9976b7fe82025-08-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091672
application number: ANDA091672
OmeprazoleOMEPRAZOLEA-S Medication Solutions5bda70ae-c3f6-450b-892f-6814795dd6ca2025-08-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091672
application number: ANDA091672
ndc (product): 50090-3876
OmeprazoleOMEPRAZOLEPHOENIX RX LLC3a9baece-03be-6c77-e063-6394a90a70322025-07-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091672
application number: ANDA091672
OmeprazoleOMEPRAZOLEAsclemed USA, Inc.9c41bcfa-b08b-3ac3-e053-2a95a90ae1c02025-02-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091672
application number: ANDA091672
OmeprazoleOMEPRAZOLENCS HealthCare of KY, LLC dba Vangard Labsd1e0c8fc-1f15-45a4-a80f-653a1dae5e562025-01-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091672
application number: ANDA091672
ndc (product): 0615-8079
Omeprazole DROMEPRAZOLEAdvanced Rx of Tennessee, LLCaf85afda-6b0c-d657-e053-2a95a90afb4b2024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091672
application number: ANDA091672
OmeprazoleOMEPRAZOLEA-S Medication Solutions30e58465-c5d2-4925-85bb-53faa6135c5c2024-09-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091672
application number: ANDA091672
ndc (product): 50090-2769
OmeprazoleOMEPRAZOLEProficient Rx LP5ad413ed-a21b-4f8b-9322-8fbb813b14d32024-09-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091672
application number: ANDA091672
ndc (product): 63187-828

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 140 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-8079OmeprazoleOmeprazoleNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8079OmeprazoleOmeprazoleNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8079OmeprazoleOmeprazoleNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
10544-972OmeprazoleOmeprazoleBlenheim Pharmacal, Inc.ANDACurrent
45865-966OmeprazoleOmeprazolemedsource pharmaceuticalsANDACurrent
50090-2023OmeprazoleOmeprazoleA-S Medication SolutionsANDACurrent
50090-2067OmeprazoleOmeprazoleA-S Medication SolutionsANDACurrent
50090-2769OmeprazoleOmeprazoleA-S Medication SolutionsANDACurrent
50090-2769OmeprazoleOmeprazoleA-S Medication SolutionsANDACurrent
50090-3876OmeprazoleOmeprazoleA-S Medication SolutionsANDACurrent
50090-3876OmeprazoleOmeprazoleA-S Medication SolutionsANDACurrent
50090-3876OmeprazoleOmeprazoleA-S Medication SolutionsANDACurrent
50090-5111OmeprazoleOmeprazoleA-S Medication SolutionsANDACurrent
50090-5501OmeprazoleOmeprazoleA-S Medication SolutionsANDACurrent
50436-0396OmeprazoleOmeprazoleUnit Dose ServicesANDACurrent
50436-0396OmeprazoleOmeprazoleUnit Dose ServicesANDACurrent
60760-396OmeprazoleOmeprazoleSt. Mary's Medical Park PharmacyANDACurrent
61919-807OMEPRAZOLEOMEPRAZOLEDirexctRXANDACurrent
61919-807OMEPRAZOLEOMEPRAZOLEDirexctRXANDACurrent
61919-807OMEPRAZOLEOMEPRAZOLEDirexctRXANDACurrent
61919-847OMEPRAZOLEOMEPRAZOLEDirect RxANDACurrent
61919-847OMEPRAZOLEOMEPRAZOLEDirect RxANDACurrent
63187-509OmeprazoleOmeprazoleProficient Rx LPANDACurrent
63187-787OmeprazoleOmeprazoleProficient Rx LPANDACurrent
63187-787OmeprazoleOmeprazoleProficient Rx LPANDACurrent
63187-820OmeprazoleOmeprazoleProficient Rx LPANDACurrent
63187-820OmeprazoleOmeprazoleProficient Rx LPANDACurrent
63187-820OmeprazoleOmeprazoleProficient Rx LPANDACurrent
63187-820OmeprazoleOmeprazoleProficient Rx LPANDACurrent
63187-820OmeprazoleOmeprazoleProficient Rx LPANDACurrent
63187-820OmeprazoleOmeprazoleProficient Rx LPANDACurrent
63187-828OmeprazoleOmeprazoleProficient Rx LPANDACurrent
63187-828OmeprazoleOmeprazoleProficient Rx LPANDACurrent
63187-828OmeprazoleOmeprazoleProficient Rx LPANDACurrent
63187-828OmeprazoleOmeprazoleProficient Rx LPANDACurrent
63187-828OmeprazoleOmeprazoleProficient Rx LPANDACurrent
63629-8108OmeprazoleOmeprazoleBryant Ranch PrepackANDACurrent
63629-8108OmeprazoleOmeprazoleBryant Ranch PrepackANDACurrent
63629-8108OmeprazoleOmeprazoleBryant Ranch PrepackANDACurrent
67296-1615OmeprazoleOmeprazoleRedPharm Drug, Inc.ANDACurrent
67296-1615OmeprazoleOmeprazoleRedPharm Drug, Inc.ANDACurrent
67296-1615OmeprazoleOmeprazoleRedPharm Drug, Inc.ANDACurrent
68071-1522OmeprazoleOmeprazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1522OmeprazoleOmeprazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1522OmeprazoleOmeprazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2199OmeprazoleOmeprazoleNuCarePharmaceuticals, Inc.ANDACurrent
68071-2199OmeprazoleOmeprazoleNuCarePharmaceuticals, Inc.ANDACurrent
68071-2432OmeprazoleOmeprazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2432OmeprazoleOmeprazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2442OmeprazoleOmeprazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2688OmeprazoleOmeprazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3007OmeprazoleOmeprazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3007OmeprazoleOmeprazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4024OmeprazoleOmeprazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4024OmeprazoleOmeprazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4024OmeprazoleOmeprazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68462-395OmeprazoleOmeprazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-395OmeprazoleOmeprazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-395OmeprazoleOmeprazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-395OmeprazoleOmeprazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-395OmeprazoleOmeprazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-395OmeprazoleOmeprazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-395OmeprazoleOmeprazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-396OmeprazoleOmeprazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-396OmeprazoleOmeprazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-396OmeprazoleOmeprazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-396OmeprazoleOmeprazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-396OmeprazoleOmeprazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-396OmeprazoleOmeprazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-396OmeprazoleOmeprazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-397OmeprazoleOmeprazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-397OmeprazoleOmeprazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-397OmeprazoleOmeprazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-397OmeprazoleOmeprazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-397OmeprazoleOmeprazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-397OmeprazoleOmeprazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-397OmeprazoleOmeprazoleGlenmark Pharmaceuticals Inc., USAANDACurrent
68788-6881OmeprazoleOmeprazolePreferred Pharmaceuticals Inc.ANDACurrent
68788-6881OmeprazoleOmeprazolePreferred Pharmaceuticals Inc.ANDACurrent
68788-6881OmeprazoleOmeprazolePreferred Pharmaceuticals Inc.ANDACurrent