FDA.reportPublic FDA data

Omeprazole

Product NDC
50090-5901
Requested package NDC
50090-5901-8
11-digit product format
500905901
Labeler code
50090
Product ID
50090-5901_83204a11-3cda-4a40-96f7-5dc3907310e3
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
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
2026-12-31
Current FDA listing
Yes

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 packagepackage50090-590150090-5901-8DDiscontinued 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
ndc (package): 50090-5901-8
ndc (product): 50090-5901
ndc11 (package): 50090590108
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

Additional Listing Data#

Finished product
Yes
Brand name base
Omeprazole
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OMEPRAZOLE20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
KG60484QX9Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198051Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6ea9a6f3-b756-4cdf-b3db-f666a2c17d66Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
873ef493-6b37-49d8-ac7f-bfca4117d2c1Product name520210607
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5901-0Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE305
50090-5901-2Omeprazole15 in 1 BOTTLECAPSULE, DELAYED RELEASE155
50090-5901-3Omeprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE605
50090-5901-4Omeprazole20 in 1 BOTTLECAPSULE, DELAYED RELEASE205
50090-5901-5Omeprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE905
50090-5901-6Omeprazole200 in 1 BOTTLECAPSULE, DELAYED RELEASE2005
50090-5901-7Omeprazole180 in 1 BOTTLECAPSULE, DELAYED RELEASE1805
50090-5901-8Omeprazole7 in 1 BOTTLECAPSULE, DELAYED RELEASE75

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5901-0EA - Each50090-590135ed557c-5e14-47c4-9463-c6b23d55f72d12022-06-06
50090-5901-2EA - Each50090-5901fe9a2dc0-55e3-4b5a-b2b7-c4ef2f64012c12022-06-06
50090-5901-3EA - Each50090-5901f5f87219-197c-445e-beda-feb7eec5458f12022-06-06
50090-5901-4EA - Each50090-59019a255aff-51bc-4bab-8a23-05cb033b19a512022-06-06
50090-5901-5EA - Each50090-5901a271c011-69f8-4122-9d5e-8b860f428d7f12022-06-06
50090-5901-6EA - Each50090-59018193a30f-586c-49c8-82f5-049f814d094e12022-06-06
50090-5901-7EA - Each50090-59017632a720-0655-4e10-bf87-d120ebeb9f7512022-06-06
50090-5901-8EA - Each50090-5901eaea8505-37e0-477b-9d1c-61826c6ac28f12022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5901OMEPRAZOLE CAPSULE, DELAYED RELEASE [A-S MEDICATION SOLUTIONS]3Current NDC, Legacy NDC, 8 package rows20240103_6ea9a6f3-b756-4cdf-b3db-f666a2c17d66.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSN6ea9a6f3-b756-4cdf-b3db-f666a2c17d665
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD6ea9a6f3-b756-4cdf-b3db-f666a2c17d665
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY6ea9a6f3-b756-4cdf-b3db-f666a2c17d665

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5901-8500905901087 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-5901-8) 2022-01-210000-00-00NoNoCurrent