Omeprazole

Product NDC
63187-787
Requested package NDC
63187-787-72
11-digit product format
631870787
Labeler code
63187
Product ID
63187-787_83ca8d89-bbd6-4a72-aeb3-ac1b4f93cc88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA091672
Marketing category
ANDA
Marketing start
2014-10-31
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
2020-12-31
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 packagepackage63187-78763187-787-72DDiscontinued by firm2026-08-03

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63187-78763187-787-72DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63187-78763187-787-72DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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
A091672-001OMEPRAZOLEOMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2014-10-31
A091672-002OMEPRAZOLEOMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALABRS2014-10-31
A091672-003OMEPRAZOLEOMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALABRS2014-10-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A091672-001AB
A091672-002AB
A091672-003AB

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 UTC2026-02A091672-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2014-10-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091672-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2014-10-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091672-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2014-10-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091672-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2014-10-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091672-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2014-10-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091672-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2014-10-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091672-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2014-10-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091672-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2014-10-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091672-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2014-10-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091672-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2014-10-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091672-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2014-10-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091672-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2014-10-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091672-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2014-10-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091672-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2014-10-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091672-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2014-10-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091672-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2014-10-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091672-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2014-10-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091672-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2014-10-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091672-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2014-10-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091672-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2014-10-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091672-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2014-10-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091672-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2014-10-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091672-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2014-10-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091672-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2014-10-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091672-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2014-10-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091672-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2014-10-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091672-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2014-10-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091672-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2014-10-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A091672-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2014-10-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A091672-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2014-10-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091672-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2014-10-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091672-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2014-10-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091672-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2014-10-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091672-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2014-10-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091672-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2014-10-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091672-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2014-10-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091672-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2014-10-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091672-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2014-10-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091672-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2014-10-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091672-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2014-10-318072bd15b7f6…

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 UTC2026-02A091672-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091672-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091672-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091672-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091672-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091672-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091672-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091672-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091672-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091672-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091672-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091672-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091672-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091672-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091672-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091672-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091672-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091672-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091672-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091672-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091672-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091672-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091672-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091672-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091672-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091672-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091672-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091672-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091672-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091672-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091672-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091672-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091672-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091672-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091672-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091672-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091672-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091672-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091672-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091672-001AB18072bd15b7f6…

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 2 · 27 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OmeprazoleOMEPRAZOLEREMEDYREPACK INC.a19ce586-59b7-4c2e-9e8d-12e8f0f058e22026-07-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091672
application number: ANDA091672
OmeprazoleOMEPRAZOLEHAWAII REPACK, INC.9359e826-5263-44fc-8dd3-9d0852fe42d62026-07-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091672
application number: ANDA091672
OmeprazoleOMEPRAZOLEBryant Ranch Prepackdcaadc8c-32d1-476f-b821-973c012b7fa72026-07-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091672
application number: ANDA091672
OmeprazoleOMEPRAZOLEUnit Dose Solutions, Inc.557d4c2c-5541-3a51-e063-6394a90ad2782026-06-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091672
application number: ANDA091672
OmeprazoleOMEPRAZOLEREMEDYREPACK INC.d9b3918c-a66e-4277-8b8f-b7ece93fa7db2026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091672
application number: ANDA091672
OmeprazoleOMEPRAZOLEST. MARY'S MEDICAL PARK PHARMACY4f5c91e6-6377-ca94-e063-6294a90a2f992026-04-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091672
application number: ANDA091672
Omeprazole DROMEPRAZOLEAdvanced Rx Pharmacy of Tennessee, LLCc8bf92c9-1bab-7985-e053-2995a90a02252026-03-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091672
application number: ANDA091672
OmeprazoleOMEPRAZOLEGlenmark Pharmaceuticals Inc., USAc6c22be1-659d-4e71-b292-701e27da201b2026-01-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091672
application number: ANDA091672
OmeprazoleOMEPRAZOLEPreferred Pharmaceuticals Inc.fa0395a7-4353-4d64-9de8-d15857a7031c2026-01-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091672
application number: ANDA091672
OmeprazoleOMEPRAZOLEA-S Medication Solutions17ccdbe0-19c1-498d-8e81-578be549b4e52025-12-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091672
application number: ANDA091672
OmeprazoleOMEPRAZOLEPreferred Pharmaceuticals Inc.aa8fc2ea-3942-453b-bc19-1e4b14ba69262025-09-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091672
application number: ANDA091672
OmeprazoleOMEPRAZOLEAphena Pharma Solutions - Tennessee, LLC3d6e07d1-38b1-f2ab-e063-6294a90a34ac2025-08-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091672
application number: ANDA091672
OmeprazoleOMEPRAZOLEAphena Pharma Solutions - Tennessee, LLCbab55f83-ba03-49a0-842a-19c9976b7fe82025-08-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091672
application number: ANDA091672
OmeprazoleOMEPRAZOLEA-S Medication Solutions5bda70ae-c3f6-450b-892f-6814795dd6ca2025-08-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091672
application number: ANDA091672
OmeprazoleOMEPRAZOLEPHOENIX RX LLC3a9baece-03be-6c77-e063-6394a90a70322025-07-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091672
application number: ANDA091672
OmeprazoleOMEPRAZOLEAsclemed USA, Inc.9c41bcfa-b08b-3ac3-e053-2a95a90ae1c02025-02-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091672
application number: ANDA091672
OmeprazoleOMEPRAZOLENCS HealthCare of KY, LLC dba Vangard Labsd1e0c8fc-1f15-45a4-a80f-653a1dae5e562025-01-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091672
application number: ANDA091672
Omeprazole DROMEPRAZOLEAdvanced Rx of Tennessee, LLCaf85afda-6b0c-d657-e053-2a95a90afb4b2024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091672
application number: ANDA091672
OmeprazoleOMEPRAZOLEA-S Medication Solutions30e58465-c5d2-4925-85bb-53faa6135c5c2024-09-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091672
application number: ANDA091672
OmeprazoleOMEPRAZOLEProficient Rx LP5ad413ed-a21b-4f8b-9322-8fbb813b14d32024-09-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091672
application number: ANDA091672

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-787-30EA - Each63187-78761dc418c-c528-4032-b7c5-b46595861f2612017-03-06
63187-787-78EA - Each63187-787205ea575-7109-4be3-b28a-610f5844a1f912017-03-06
63187-787-90EA - Each63187-7875a22248a-e784-4d4c-bd83-8073d98043df12017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-787OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]3Legacy NDC20191115_1fdf446d-cd4e-491f-ac8b-c35c74fb2c91.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-787-7263187078772120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-787-72) 2016-12-010000-00-00NoNoCurrent