FDA.reportPublic FDA data

Omeprazole

Product NDC
60760-489
Requested package NDC
60760-489-60
11-digit product format
607600489
Labeler code
60760
Product ID
60760-489_f19ddbec-d77c-a3f1-e053-2a95a90a65d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
St. Mary's Medical Park Pharmacy
Application
ANDA075410
Marketing category
ANDA
Marketing start
2021-05-21
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
2024-12-31
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 packagepackage60760-48960760-489-60DDiscontinued 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
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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-489-07EA - Each60760-489284c15aa-faf1-4add-8d56-ce63a27e62a612021-08-05
60760-489-30EA - Each60760-48906600252-288f-4108-b59f-5c6d94db2a1d12021-08-05
60760-489-60EA - Each60760-489d3167d40-d4b4-447f-b412-de462466652a12021-08-05
60760-489-90EA - Each60760-489229c114b-9a25-41b9-877e-9c9d6be8139112021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-489OMEPRAZOLE CAPSULE, DELAYED RELEASE [ST. MARY'S MEDICAL PARK PHARMACY]2Legacy NDC20230112_c32d1a5d-bfbd-9604-e053-2995a90a49c5.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60760-489-606076004896060 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (60760-489-60) 2021-06-070000-00-00NoNoCurrent