Omeprazole

Product NDC
80175-0715
Requested package NDC
80175-0715-3
11-digit product format
801750715
Labeler code
80175
Product ID
80175-0715_bdc0b6d7-270d-12bd-e053-2a95a90a73ca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Central Packaging
Application
ANDA075576
Marketing category
ANDA
Marketing start
2019-10-25
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
2022-12-31
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 packagepackage80175-071580175-0715-3IInactivated by FDA2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 2 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage80175-071580175-0715-3IInactivated by FDAexcluded / ndc_excluded.zipbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage80175-071580175-0715-3IInactivated by FDAexcluded / ndc_excluded.zip8dfbde2a14a4…c9ff85d89658…

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
A075576-001OMEPRAZOLEOMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-21
A075576-002OMEPRAZOLEOMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22
A075576-003OMEPRAZOLEOMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075576-001AB
A075576-002AB
A075576-003AB

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A075576-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075576-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075576-003OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075576-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075576-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075576-003OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A075576-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075576-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075576-003OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075576-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075576-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075576-003OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075576-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075576-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075576-003OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075576-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075576-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075576-003OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075576-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075576-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075576-003OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075576-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075576-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075576-003OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075576-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075576-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075576-003OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075576-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A075576-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A075576-003OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075576-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075576-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075576-003OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075576-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075576-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075576-003OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075576-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075576-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-221e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075576-003OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075576-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-218072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A075576-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075576-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075576-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075576-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075576-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075576-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075576-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075576-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075576-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075576-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075576-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075576-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075576-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075576-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075576-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075576-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075576-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075576-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075576-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075576-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075576-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075576-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075576-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075576-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075576-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075576-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075576-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075576-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075576-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075576-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075576-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075576-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075576-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075576-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075576-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075576-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075576-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075576-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075576-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075576-001AB18072bd15b7f6…

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 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OmeprazoleOMEPRAZOLESt. Mary's Medical Park Pharmacy1eb57c13-25ed-70bc-e063-6294a90afdac2026-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075576
application number: ANDA075576
OmeprazoleOMEPRAZOLENorthwind Health Company, LLCaae3bf9f-5d05-889f-e053-2995a90a5ff22025-12-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075576
application number: ANDA075576
OmeprazoleOMEPRAZOLEQPharma, Inc.f5dcf0b2-4fa2-023a-e053-2995a90a183a2025-12-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075576
application number: ANDA075576
OmeprazoleOMEPRAZOLEQuallent Pharmaceuticals Health LLC665e9877-85ac-fdb6-54ac-1c47941ceab82025-11-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075576
application number: ANDA075576
OmeprazoleOMEPRAZOLEPD-Rx Pharmaceuticals, Inc.e235ef89-3592-4ca1-8c13-d7ce84b1001c2025-10-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075576
application number: ANDA075576
OmeprazoleOMEPRAZOLEAmerican Health Packaginga17e415e-a559-4a8d-a455-699184a015232025-02-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075576
application number: ANDA075576
Omeprazole DROMEPRAZOLEAdvanced Rx of Tennessee, LLCaf85e324-ef9f-196c-e053-2995a90a384e2024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075576
application number: ANDA075576
OmeprazoleOMEPRAZOLEQuality Care Products, LLC581d1c3d-457a-41f2-8db0-5b6219cdcb092024-12-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075576
application number: ANDA075576
OmeprazoleOMEPRAZOLEProficient Rx LPf0f61a89-700d-481d-9255-6f9a9afa70252024-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075576
application number: ANDA075576
OmeprazoleOMEPRAZOLEAdvanced Rx of Tennessee, LLC1d4ecc1e-5180-f75e-e063-6394a90a51a62024-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075576
application number: ANDA075576
OmeprazoleOMEPRAZOLEBryant Ranch Prepacke1f20429-cfaa-420b-a65a-271be37eb7992024-05-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075576
application number: ANDA075576
OmeprazoleOMEPRAZOLEDr. Reddy's Laboratories Limited72fb11b6-b08c-2f02-d82b-f60f523949032024-04-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075576
application number: ANDA075576
OmeprazoleOMEPRAZOLEA-S Medication Solutionsb129fe93-c8a2-4ae8-ad1b-8f9ae5779b682023-09-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075576
application number: ANDA075576
OmeprazoleOMEPRAZOLENorthStar Rx LLCc5af5f4b-17be-7245-b281-f27c878312422023-06-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075576
application number: ANDA075576

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80175-0715-3Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80175-0715OMEPRAZOLE CAPSULE, DELAYED RELEASE [CENTRAL PACKAGING]1Legacy NDC, 1 package rows20210225_bc1d591a-3835-e251-e053-2a95a90aab89.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSNbc1d591a-3835-e251-e053-2a95a90aab891
198051omeprazole 20 MG Delayed Release Oral CapsuleSCDbc1d591a-3835-e251-e053-2a95a90aab891
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSYbc1d591a-3835-e251-e053-2a95a90aab891

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
80175-0715-38017507150330 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80175-0715-3) 2019-10-250000-00-00NoNoCurrent