Omeprazole

Product NDC
67296-0882
Requested package NDC
67296-0882-1
11-digit product format
672960882
Labeler code
67296
Product ID
67296-0882_9c9b1dc6-f351-f653-e053-2a95a90a6991
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA076048
Marketing category
ANDA
Marketing start
2003-11-11
Marketing end
0000-00-00
Substance
OMEPRAZOLE
Active strength
20 mg/1
Pharmacologic classes
Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage67296-088267296-0882-1IInactivated by FDA2026-10-05

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 · 18 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…

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
A076048-001OMEPRAZOLEOMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22
A076048-002OMEPRAZOLEOMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22
A076048-003OMEPRAZOLEOMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076048-001AB
A076048-002AB
A076048-003AB

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 22:38:342026-08A076048-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-2284e616aacf4f…
2026-09-14 22:38:342026-08A076048-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-2284e616aacf4f…
2026-09-14 22:38:342026-08A076048-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-2184e616aacf4f…
2026-08-18 06:07:402026-07A076048-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22caaa826d4ba7…
2026-08-18 06:07:402026-07A076048-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22caaa826d4ba7…
2026-08-18 06:07:402026-07A076048-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076048-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076048-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076048-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076048-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076048-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076048-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076048-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076048-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076048-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076048-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076048-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076048-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076048-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076048-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076048-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076048-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076048-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076048-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076048-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076048-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076048-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076048-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076048-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076048-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076048-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076048-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076048-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076048-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A076048-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A076048-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076048-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076048-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076048-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076048-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22301d65b070ca…

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 22:38:342026-08A076048-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A076048-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A076048-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A076048-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076048-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076048-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076048-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076048-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076048-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076048-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076048-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076048-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076048-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076048-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076048-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076048-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076048-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076048-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076048-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076048-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076048-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076048-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076048-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076048-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076048-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076048-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076048-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076048-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076048-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076048-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076048-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076048-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076048-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076048-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076048-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076048-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076048-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076048-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076048-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076048-001AB1301d65b070ca…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
873ef493-6b37-49d8-ac7f-bfca4117d2c1Product name520210607
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67296-0882-12022-01-28C16284748780-1d6a99b39-85cb-a426-e053-dadaa90af4c243028d58-90a1-1bf1-e054-00144ff8d46c
67296-0882-22022-01-28C16284748780-1d6a99b39-85cb-a426-e053-dadaa90af4c243028d58-90a1-1bf1-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-0882-1Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE305
67296-0882-2Omeprazole20 in 1 BOTTLECAPSULE, DELAYED RELEASE205

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-0882OMEPRAZOLE CAPSULE, DELAYED RELEASE [REDPHARM DRUG, INC.]5Legacy NDC, 2 package rows20200121_43028d58-90a1-1bf1-e054-00144ff8d46c.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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OmeprazoleOMEPRAZOLEBryant Ranch Prepack1249c42d-6358-48b3-8fe0-10333c7f501d2024-10-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076048
application number: ANDA076048
OmeprazoleOMEPRAZOLEBryant Ranch Prepack44349466-73ea-4053-8ff6-5b4b7372c9cd2024-10-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076048
application number: ANDA076048
OmeprazoleOMEPRAZOLEProficient Rx LP03ac077f-3873-4087-96d0-89049161dea92024-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076048
application number: ANDA076048
OmeprazoleOMEPRAZOLEProficient Rx LP253451a6-02a9-4b27-aed7-f3dbc2e096822024-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076048
application number: ANDA076048
OmeprazoleOMEPRAZOLEApotex Corpb83329ac-a65e-b3af-a3fb-c5a6c740e5e72024-04-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076048
application number: ANDA076048
OmeprazoleOMEPRAZOLEAphena Pharma Solutions - Tennessee, LLCa0dc4ffa-db18-4871-9d36-51d02e3b2bd92019-03-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076048
application number: ANDA076048

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSN43028d58-90a1-1bf1-e054-00144ff8d46c5
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD43028d58-90a1-1bf1-e054-00144ff8d46c5
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY43028d58-90a1-1bf1-e054-00144ff8d46c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67296-0882-16729608820130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67296-0882-1) 2003-11-110000-00-00NoNoCurrent