FDA.reportPublic FDA data

Omeprazole

Product NDC
51407-641
11-digit product format
514070641
Labeler code
51407
Product ID
51407-641_3ba5e1e5-159d-2492-e063-6294a90a6c8b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA212977
Marketing category
ANDA
Marketing start
2020-12-10
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

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
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
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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198051Internal RxNorm lookup
200329Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ded71262-d17f-3799-e053-2995a90a5427Available 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51407-641-002023-08-14C16284748780-10191ceaa-63eb-198a-e063-dbdaa90aec3eOMEPRAZOLE DELAYED-RELEASE CAPSULES. These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1989
51407-641-012023-08-14C16284748780-10191ceaa-63eb-198a-e063-dbdaa90aec3eOMEPRAZOLE DELAYED-RELEASE CAPSULES. These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1989
51407-641-102023-08-14C16284748780-10191ceaa-63eb-198a-e063-dbdaa90aec3eOMEPRAZOLE DELAYED-RELEASE CAPSULES. These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1989
51407-641-002023-07-28C16284748780-10191ceaa-63eb-198a-e063-dbdaa90aec3eOMEPRAZOLE DELAYED-RELEASE CAPSULES. These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1989
51407-641-012023-07-28C16284748780-10191ceaa-63eb-198a-e063-dbdaa90aec3eOMEPRAZOLE DELAYED-RELEASE CAPSULES. These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1989
51407-641-102023-07-28C16284748780-10191ceaa-63eb-198a-e063-dbdaa90aec3eOMEPRAZOLE DELAYED-RELEASE CAPSULES. These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1989

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51407-641-00Omeprazole1 in 1 PAILCAPSULE, DELAYED RELEASE17
51407-641-01Omeprazole100 in 1 BOTTLECAPSULE, DELAYED RELEASE1007
51407-641-10Omeprazole1000 in 1 BOTTLECAPSULE, DELAYED RELEASE10007
51407-641-90Omeprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-641-01EA - Each51407-64137d62e4f-8169-4221-bbc8-a11b75b4feb512022-06-06
51407-641-10EA - Each51407-641e6d03d5c-3b3d-4f00-880e-6b268d510b4b12022-06-06
51407-641-90EA - Each51407-641acf4aaba-7ea0-4060-9009-3475ce9c0e5f12025-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-641OMEPRAZOLE CAPSULE, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]6Current NDC, Legacy NDC, 4 package rows20250501_ded71262-d17f-3799-e053-2995a90a5427.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSNe87d2206-9c06-438c-947b-10b29a879d7b8
198051omeprazole 20 MG Delayed Release Oral CapsuleSCDe87d2206-9c06-438c-947b-10b29a879d7b8
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSYe87d2206-9c06-438c-947b-10b29a879d7b8
198051omeprazole 20 MG Delayed Release Oral CapsulePSNded71262-d17f-3799-e053-2995a90a54277
200329omeprazole 40 MG Delayed Release Oral CapsulePSNded71262-d17f-3799-e053-2995a90a54277
198051omeprazole 20 MG Delayed Release Oral CapsuleSCDded71262-d17f-3799-e053-2995a90a54277
200329omeprazole 40 MG Delayed Release Oral CapsuleSCDded71262-d17f-3799-e053-2995a90a54277
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSYded71262-d17f-3799-e053-2995a90a54277

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51407-641-00514070641001 CAPSULE, DELAYED RELEASE in 1 PAIL (51407-641-00) 2022-05-110000-00-00NoNoCurrent
51407-641-0151407064101100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (51407-641-01) 2022-05-110000-00-00NoNoCurrent
51407-641-10514070641101000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (51407-641-10) 2022-05-110000-00-00NoNoCurrent
51407-641-905140706419090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (51407-641-90) 2025-02-03NoNoCurrent