FDA.reportPublic FDA data

Omeprazole

Product NDC
50090-5903
Requested package NDC
50090-5903-0
11-digit product format
500905903
Labeler code
50090
Product ID
50090-5903_95b7e297-fda2-4e1e-ac9a-6fb571173687
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA212977
Marketing category
ANDA
Marketing start
2019-02-20
Marketing end
0000-00-00
Substance
OMEPRAZOLE
Active strength
20 mg/1
Pharmacologic classes
Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50090-590350090-5903-0DDiscontinued by firm2026-07-31

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
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
OmeprazoleOMEPRAZOLEA-S Medication Solutions530a8a66-48ad-474f-b170-c6fac95753ec2025-10-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212977
application number: ANDA212977
OmeprazoleOMEPRAZOLEGolden State Medical Supply, Inc.ded71262-d17f-3799-e053-2995a90a54272025-08-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212977
application number: ANDA212977
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
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
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
OmeprazoleOMEPRAZOLEProficient Rx LP2fc5065c-5850-469b-b357-fa4df30a8f782022-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212977
application number: ANDA212977
OmeprazoleOMEPRAZOLEXiromed, LLC38bd8e13-591e-f11b-7d8a-11717c56493c2022-02-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212977
application number: ANDA212977

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5903-0EA - Each50090-5903999cdc4c-1f87-4d64-b9fc-72e464273cc212022-06-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5903-05009059030032 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-5903-0) 2022-01-130000-00-00NoNoCurrent