FDA.reportPublic FDA data

Omeprazole

Product NDC
51407-256
11-digit product format
514070256
Labeler code
51407
Product ID
51407-256_de22b48e-7842-5718-e053-2a95a90a0baa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA075410
Marketing category
ANDA
Marketing start
2002-11-01
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct51407-256DDiscontinued by firm2026-08-03
excluded packagepackage51407-25651407-256-00DDiscontinued by firm2026-08-03
excluded packagepackage51407-25651407-256-01DDiscontinued by firm2026-08-03
excluded packagepackage51407-25651407-256-10DDiscontinued by firm2026-08-03

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
A075410-001OMEPRAZOLEOMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2002-11-01
A075410-002OMEPRAZOLEOMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2002-11-01
A075410-003OMEPRAZOLEOMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075410-001AB
A075410-002AB
A075410-003AB

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 22:54:322026-06A075410-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2002-11-01a50c72e98297…
2026-08-01 22:54:322026-06A075410-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2002-11-01a50c72e98297…
2026-08-01 22:54:322026-06A075410-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-23a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A075410-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A075410-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A075410-003AB1a50c72e98297…

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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OmeprazoleOMEPRAZOLEChartwell RX, LLC10f5502a-2e63-4f2a-a3ba-ddc5bd4030512025-12-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075410
application number: ANDA075410
OmeprazoleOMEPRAZOLEPD-Rx Pharmaceuticals, Inc.ed9895ae-3d18-434c-8b56-47bccdc8fe6d2025-10-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075410
application number: ANDA075410
OmeprazoleOMEPRAZOLENuCare Pharmaceuticals,Inc.ad675ef6-5377-b9f2-e053-2995a90a06e92024-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075410
application number: ANDA075410
OmeprazoleOMEPRAZOLENuCare Pharmaceuticals,Inc.55a1fb3c-f040-2e39-e054-00144ff8d46c2024-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075410
application number: ANDA075410
OmeprazoleOMEPRAZOLENuCare Pharmaceuticals,Inc.8991d464-7abc-4350-e053-2995a90a4ea72024-06-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075410
application number: ANDA075410
OmeprazoleOMEPRAZOLEBryant Ranch Prepack1318a1c1-222d-471a-92d6-3632c82fb9992024-05-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075410
application number: ANDA075410
OmeprazoleOMEPRAZOLEBryant Ranch Prepack18f5a7cc-40d8-4aeb-a601-47bc9024f1302024-05-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075410
application number: ANDA075410
OmeprazoleOMEPRAZOLELannett Company, Inc.92201fb1-4570-42db-8da3-3b8c0e291d322023-04-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075410
application number: ANDA075410
OmeprazoleOMEPRAZOLEProficient Rx LP9786b04f-f827-460b-91bc-c0ac967f95dd2022-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075410
application number: ANDA075410
OmeprazoleOMEPRAZOLEAphena Pharma Solutions - Tennessee, LLC4b188d97-f1b3-468d-9818-b8333bf24b5a2020-12-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075410
application number: ANDA075410

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-256-01EA - Each51407-2567f23313e-3507-47c5-a228-628cdb73c45112020-03-10
51407-256-10EA - Each51407-256299c1661-2631-4ab7-8384-af6a1af6e77d12020-03-10

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSN767a7c15-aa5d-4f49-b337-f507f534746f3
200329omeprazole 40 MG Delayed Release Oral CapsulePSN767a7c15-aa5d-4f49-b337-f507f534746f3
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD767a7c15-aa5d-4f49-b337-f507f534746f3
200329omeprazole 40 MG Delayed Release Oral CapsuleSCD767a7c15-aa5d-4f49-b337-f507f534746f3
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY767a7c15-aa5d-4f49-b337-f507f534746f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51407-256-005140702560052500 CAPSULE, DELAYED RELEASE in 1 DRUM (51407-256-00) 2019-06-060000-00-00NoNoCurrent
51407-256-0151407025601100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (51407-256-01) 2020-02-200000-00-00NoNoCurrent
51407-256-10514070256101000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (51407-256-10) 2020-02-200000-00-00NoNoCurrent