FDA.reportPublic FDA data

Application 212977

Type
ANDA
Sponsor
XIROMED

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
A212977-001OMEPRAZOLEOMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-12-10
A212977-002OMEPRAZOLEOMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-12-10
A212977-003OMEPRAZOLEOMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2024-12-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A212977-001AB
A212977-002AB
A212977-003AB

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 22:54:322026-06A212977-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-12-10a50c72e98297…
2026-08-01 22:54:322026-06A212977-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-12-10a50c72e98297…
2026-08-01 22:54:322026-06A212977-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2024-12-27a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A212977-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A212977-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A212977-003AB1a50c72e98297…

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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OmeprazoleOMEPRAZOLEREMEDYREPACK INC.ded0df8b-1813-4595-ac2b-5499704bfd482026-04-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212977
application number: ANDA212977
ndc (product): 70518-3278
OmeprazoleOMEPRAZOLEAphena Pharma Solutions - Tennessee, LLC43090803-37de-77e3-e063-6294a90a8c432025-11-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212977
application number: ANDA212977
OmeprazoleOMEPRAZOLEA-S Medication Solutions6ea9a6f3-b756-4cdf-b3db-f666a2c17d662025-10-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212977
application number: ANDA212977
ndc (product): 50090-5901
OmeprazoleOMEPRAZOLEA-S Medication Solutions530a8a66-48ad-474f-b170-c6fac95753ec2025-10-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212977
application number: ANDA212977
ndc (product): 50090-5902
OmeprazoleOMEPRAZOLEGolden State Medical Supply, Inc.ded71262-d17f-3799-e053-2995a90a54272025-08-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212977
application number: ANDA212977
ndc (product): 51407-641
OmeprazoleOMEPRAZOLEGolden State Medical Supply, Inc.f873dc20-c817-5e4f-e053-6394a90a04f22025-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212977
application number: ANDA212977
OmeprazoleOMEPRAZOLEAphena Pharma Solutions - Tennessee, LLCe87d2206-9c06-438c-947b-10b29a879d7b2025-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212977
application number: ANDA212977
ndc (product): 71610-663
OmeprazoleOMEPRAZOLEAphena Pharma Solutions - Tennessee, LLC2e5d1b21-6b32-0c8d-e063-6294a90a84312025-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212977
application number: ANDA212977
OmeprazoleOMEPRAZOLENCS HealthCare of KY, LLC dba Vangard Labsf226173f-4318-43e0-847a-8ea237e6b41d2025-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212977
application number: ANDA212977
ndc (product): 0615-8406
OmeprazoleOMEPRAZOLEBoswell Pharmacy Services LLC d/b/a BPS Wholesale1ab3d84c-c563-6f04-e063-6394a90a34ff2024-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212977
application number: ANDA212977
OmeprazoleOMEPRAZOLEProficient Rx LP13b379ef-7982-434d-9e6b-e01cd2b398d22023-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212977
application number: ANDA212977
ndc (product): 71205-613
OmeprazoleOMEPRAZOLEProficient Rx LP2fc5065c-5850-469b-b357-fa4df30a8f782022-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212977
application number: ANDA212977
ndc (product): 71205-907
OmeprazoleOMEPRAZOLEXiromed, LLC38bd8e13-591e-f11b-7d8a-11717c56493c2022-02-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212977
application number: ANDA212977
ndc (product): 70700-150
ndc (product): 70700-149

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 34 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-8406OmeprazoleOmeprazoleNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8406OmeprazoleOmeprazoleNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
50090-5901OmeprazoleOmeprazoleA-S Medication SolutionsANDACurrent
50090-5902OmeprazoleOmeprazoleA-S Medication SolutionsANDACurrent
50090-5903OmeprazoleOmeprazoleA-S Medication SolutionsANDACurrent
51407-641OmeprazoleOmeprazoleGolden State Medical Supply, Inc.ANDACurrent
51407-641OmeprazoleOmeprazoleGolden State Medical Supply, Inc.ANDACurrent
70518-3278OmeprazoleOmeprazoleREMEDYREPACK INC.ANDACurrent
70518-3278OmeprazoleOmeprazoleREMEDYREPACK INC.ANDACurrent
70518-3278OmeprazoleOmeprazoleREMEDYREPACK INC.ANDACurrent
70700-149OmeprazoleOmeprazoleXiromed, LLCANDACurrent
70700-149OmeprazoleOmeprazoleXiromed, LLCANDACurrent
70700-149OmeprazoleOmeprazoleXiromed, LLCANDACurrent
70700-149OmeprazoleOmeprazoleXiromed, LLCANDACurrent
70700-149OmeprazoleOmeprazoleXiromed, LLCANDACurrent
70700-149OmeprazoleOmeprazoleXiromed, LLCANDACurrent
70700-149OmeprazoleOmeprazoleXiromed, LLCANDACurrent
70700-149OmeprazoleOmeprazoleXiromed, LLCANDACurrent
70700-150OmeprazoleOmeprazoleXiromed, LLCANDACurrent
70700-150OmeprazoleOmeprazoleXiromed, LLCANDACurrent
70700-150OmeprazoleOmeprazoleXiromed, LLCANDACurrent
70700-150OmeprazoleOmeprazoleXiromed, LLCANDACurrent
70700-150OmeprazoleOmeprazoleXiromed, LLCANDACurrent
70700-150OmeprazoleOmeprazoleXiromed, LLCANDACurrent
70700-150OmeprazoleOmeprazoleXiromed, LLCANDACurrent
70700-150OmeprazoleOmeprazoleXiromed, LLCANDACurrent
71205-613OmeprazoleOmeprazoleProficient Rx LPANDACurrent
71205-613OmeprazoleOmeprazoleProficient Rx LPANDACurrent
71205-613OmeprazoleOmeprazoleProficient Rx LPANDACurrent
71205-907OmeprazoleOmeprazoleProficient Rx LPANDACurrent
71205-907OmeprazoleOmeprazoleProficient Rx LPANDACurrent
71610-663OmeprazoleOmeprazoleAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-663OmeprazoleOmeprazoleAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-663OmeprazoleOmeprazoleAphena Pharma Solutions - Tennessee, LLCANDACurrent