fenofibrate

Product NDC
68788-7254
11-digit product format
687887254
Labeler code
68788
Product ID
68788-7254_b4abffde-0c9b-4e97-9d7b-b779367bad39
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fenofibrate
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA090715
Marketing category
ANDA
Marketing start
2018-09-17
Marketing end
0000-00-00
Substance
FENOFIBRATE
Active strength
145 mg/1
Pharmacologic classes
Peroxisome Proliferator Receptor alpha Agonist [EPC]
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68788-7254DDiscontinued by firm2026-08-07
excluded packagepackage68788-725468788-7254-1DDiscontinued by firm2026-08-07
excluded packagepackage68788-725468788-7254-3DDiscontinued by firm2026-08-07
excluded packagepackage68788-725468788-7254-6DDiscontinued by firm2026-08-07
excluded packagepackage68788-725468788-7254-9DDiscontinued by firm2026-08-07

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 · 60 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-7254-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-7254-6d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-7254-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68788-7254-9d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-7254-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-7254-6f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-7254-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68788-7254-9f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-7254-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-7254-62ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-7254-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68788-7254-92ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-7254-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-7254-6a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-7254-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68788-7254-9a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-7254-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-7254-6cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-7254-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68788-7254-9cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-7254-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-7254-6cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-7254-3cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68788-7254-9cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-7254-1302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-7254-6302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-7254-3302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68788-7254-9302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68788-7254-1ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68788-7254-6ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68788-7254-3ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68788-7254-9ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68788-7254-10efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68788-7254-60efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68788-7254-30efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68788-7254-90efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68788-7254-1ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68788-7254-6ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68788-7254-3ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68788-7254-9ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68788-7254-1367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68788-7254-6367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68788-7254-3367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68788-7254-9367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68788-7254-1557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68788-7254-6557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68788-7254-3557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68788-7254-9557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090715-001FENOFIBRATEFENOFIBRATE48MGTABLET / ORAL2012-04-05
A090715-002FENOFIBRATEFENOFIBRATE145MGTABLET / ORAL2012-04-05

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090715-001FENOFIBRATE48MGTABLET / ORAL2012-04-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090715-002FENOFIBRATE145MGTABLET / ORAL2012-04-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090715-001FENOFIBRATE48MGTABLET / ORAL2012-04-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090715-002FENOFIBRATE145MGTABLET / ORAL2012-04-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A090715-001FENOFIBRATE48MGTABLET / ORALAB2012-04-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090715-002FENOFIBRATE145MGTABLET / ORALAB2012-04-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090715-001FENOFIBRATE48MGTABLET / ORALAB2012-04-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090715-002FENOFIBRATE145MGTABLET / ORALAB2012-04-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090715-001FENOFIBRATE48MGTABLET / ORALAB2012-04-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090715-002FENOFIBRATE145MGTABLET / ORALAB2012-04-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090715-001FENOFIBRATE48MGTABLET / ORALAB2012-04-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090715-002FENOFIBRATE145MGTABLET / ORALAB2012-04-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090715-001FENOFIBRATE48MGTABLET / ORALAB2012-04-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090715-002FENOFIBRATE145MGTABLET / ORALAB2012-04-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090715-001FENOFIBRATE48MGTABLET / ORALAB2012-04-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090715-002FENOFIBRATE145MGTABLET / ORALAB2012-04-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090715-001FENOFIBRATE48MGTABLET / ORALAB2012-04-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090715-002FENOFIBRATE145MGTABLET / ORALAB2012-04-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090715-001FENOFIBRATE48MGTABLET / ORALAB2012-04-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A090715-002FENOFIBRATE145MGTABLET / ORALAB2012-04-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090715-001FENOFIBRATE48MGTABLET / ORALAB2012-04-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090715-002FENOFIBRATE145MGTABLET / ORALAB2012-04-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090715-001FENOFIBRATE48MGTABLET / ORALAB2012-04-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090715-002FENOFIBRATE145MGTABLET / ORALAB2012-04-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090715-001FENOFIBRATE48MGTABLET / ORALAB2012-04-051e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090715-002FENOFIBRATE145MGTABLET / ORALAB2012-04-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090715-001FENOFIBRATE48MGTABLET / ORALAB2012-04-058072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090715-002FENOFIBRATE145MGTABLET / ORALAB2012-04-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090715-001FENOFIBRATE48MGTABLET / ORALAB2012-04-055c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090715-002FENOFIBRATE145MGTABLET / ORALAB2012-04-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090715-001FENOFIBRATE48MGTABLET / ORALAB2012-04-055d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090715-002FENOFIBRATE145MGTABLET / ORALAB2012-04-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090715-001FENOFIBRATE48MGTABLET / ORALAB2012-04-054b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090715-002FENOFIBRATE145MGTABLET / ORALAB2012-04-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090715-001FENOFIBRATE48MGTABLET / ORALAB2012-04-0574a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090715-002FENOFIBRATE145MGTABLET / ORALAB2012-04-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090715-001FENOFIBRATE48MGTABLET / ORALAB2012-04-05bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090715-002FENOFIBRATE145MGTABLET / ORALAB2012-04-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090715-001FENOFIBRATE48MGTABLET / ORALAB2012-04-05782e0a99824c…
2021-12-28 21:50 UTC2021-12A090715-002FENOFIBRATE145MGTABLET / ORALAB2012-04-05782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-08-23 18:47 UTC2025-08A090715-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090715-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090715-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090715-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090715-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090715-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090715-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090715-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090715-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090715-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090715-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090715-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090715-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090715-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090715-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090715-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090715-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090715-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090715-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090715-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090715-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090715-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090715-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090715-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090715-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090715-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090715-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090715-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090715-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090715-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090715-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090715-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090715-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090715-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090715-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A090715-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090715-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090715-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A090715-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A090715-002AB15aa47cf7b7d7…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7254-1EA - Each68788-7254c71f9059-a48e-487f-8ef8-0fa976a3a02f12018-11-06
68788-7254-3EA - Each68788-72543766cb90-61f3-4cd4-88fb-c673b53d0ade12018-11-06
68788-7254-6EA - Each68788-7254a151717b-4560-4816-afff-af4f1ec0ce8412018-11-06
68788-7254-9EA - Each68788-7254eff53652-1ca9-4855-915c-1acdeb5966bd12018-11-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7254-168788725401100 TABLET in 1 BOTTLE (68788-7254-1) 100 tablet2018-09-170000-00-00NoNoCurrent
68788-7254-36878872540330 TABLET in 1 BOTTLE (68788-7254-3) 30 tablet2018-09-170000-00-00NoNoCurrent
68788-7254-66878872540660 TABLET in 1 BOTTLE (68788-7254-6) 60 tablet2018-09-170000-00-00NoNoCurrent
68788-7254-96878872540990 TABLET in 1 BOTTLE (68788-7254-9) 90 tablet2018-09-170000-00-00NoNoCurrent