Omeprazole

Product NDC
68071-4906
11-digit product format
680714906
Labeler code
68071
Product ID
68071-4906_1ae2448f-a44a-4611-e063-6294a90aa956
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA075410
Marketing category
ANDA
Marketing start
2009-01-23
Substance
OMEPRAZOLE
Active strength
40 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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68071-4906-98af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68071-4906-9834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68071-4906-91332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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.

Product history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A075410-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2002-11-0184e616aacf4f…
2026-09-14 22:38:342026-08A075410-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2002-11-0184e616aacf4f…
2026-09-14 22:38:342026-08A075410-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-2384e616aacf4f…
2026-08-18 06:07:402026-07A075410-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2002-11-01caaa826d4ba7…
2026-08-18 06:07:402026-07A075410-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2002-11-01caaa826d4ba7…
2026-08-18 06:07:402026-07A075410-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075410-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2002-11-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075410-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2002-11-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075410-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075410-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2002-11-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075410-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2002-11-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075410-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A075410-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2002-11-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075410-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2002-11-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075410-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075410-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2002-11-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075410-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2002-11-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075410-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075410-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2002-11-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075410-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2002-11-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075410-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075410-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2002-11-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075410-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2002-11-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075410-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075410-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2002-11-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075410-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2002-11-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075410-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075410-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2002-11-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075410-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2002-11-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075410-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075410-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2002-11-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075410-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2002-11-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075410-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075410-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2002-11-01d06236e962d9…
2024-10-29 15:01 UTC2024-10A075410-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2002-11-01d06236e962d9…
2024-10-29 15:01 UTC2024-10A075410-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075410-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2002-11-0179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075410-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2002-11-0179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075410-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075410-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2002-11-01301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A075410-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A075410-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A075410-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A075410-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075410-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075410-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075410-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075410-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075410-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075410-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075410-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075410-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075410-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075410-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075410-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075410-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075410-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075410-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075410-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075410-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075410-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075410-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075410-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075410-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075410-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075410-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075410-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075410-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075410-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075410-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075410-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075410-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075410-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075410-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075410-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075410-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075410-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075410-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075410-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075410-001AB1301d65b070ca…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OMEPRAZOLE40 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
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
8991d464-7abc-4350-e053-2995a90a4ea7Available on FDA.report

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4906-9Omeprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4906OMEPRAZOLE CAPSULE, DELAYED RELEASE [NUCARE PHARMACEUTICALS,INC.]3Current NDC, Legacy NDC, 1 package rows20240627_8991d464-7abc-4350-e053-2995a90a4ea7.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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
ndc (product): 68071-4906
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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200329omeprazole 40 MG Delayed Release Oral CapsulePSN8991d464-7abc-4350-e053-2995a90a4ea73
200329omeprazole 40 MG Delayed Release Oral CapsuleSCD8991d464-7abc-4350-e053-2995a90a4ea73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-4906-96807149060990 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-4906-9) 2019-05-230000-00-00NoNoCurrent