Fenofibrate

Product NDC
71335-1292
11-digit product format
713351292
Labeler code
71335
Product ID
71335-1292_00ad8306-c936-43f8-91b6-14a713beb0c6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fenofibrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA200884
Marketing category
ANDA
Marketing start
2018-06-01
Marketing end
0000-00-00
Substance
FENOFIBRATE
Active strength
48 mg/1
Pharmacologic classes
Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 8 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct71335-1292DDiscontinued by firm2026-08-10
excluded productproduct71335-1292DDiscontinued by firm2026-08-10
excluded packagepackage71335-129271335-1292-1DDiscontinued by firm2026-08-10
excluded packagepackage71335-129271335-1292-2DDiscontinued by firm2026-08-10
excluded packagepackage71335-129271335-1292-3DDiscontinued by firm2026-08-10
excluded packagepackage71335-129271335-1292-1DDiscontinued by firm2026-08-10
excluded packagepackage71335-129271335-1292-2DDiscontinued by firm2026-08-10
excluded packagepackage71335-129271335-1292-3DDiscontinued by firm2026-08-10

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 2 · 108 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-1292-3DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-1292-2DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-1292-1DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-1292-2DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-1292-3DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-1292-1DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-1292-3DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-1292-2DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-1292-1DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-1292-2DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-1292-3DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-1292-1DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-1292-1DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-1292-2IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-1292-2DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-1292-1IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-1292-3IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-1292-3DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-1292-1DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-1292-2IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-1292-2DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-1292-1IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-1292-3IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-1292-3DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-1292-1DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-1292-2IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-1292-2DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-1292-1IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-1292-3IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-1292-3DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-1292-1DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-1292-2IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-1292-2DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-1292-1IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-1292-3IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-1292-3DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-1292-1DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-1292-2IInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-1292-2DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-1292-1IInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-1292-3IInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-1292-3DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71335-1292-1DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71335-1292-2IInactivated by FDAed331223b511…672a5bd82f5f…

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
A200884-001FENOFIBRATEFENOFIBRATE48MGTABLET / ORAL2017-09-07
A200884-002FENOFIBRATEFENOFIBRATE145MGTABLET / ORAL2017-09-07

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 UTC2026-02A200884-001FENOFIBRATE48MGTABLET / ORAL2017-09-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200884-002FENOFIBRATE145MGTABLET / ORAL2017-09-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200884-001FENOFIBRATE48MGTABLET / ORAL2017-09-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200884-002FENOFIBRATE145MGTABLET / ORAL2017-09-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A200884-001FENOFIBRATE48MGTABLET / ORAL2017-09-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200884-002FENOFIBRATE145MGTABLET / ORAL2017-09-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200884-001FENOFIBRATE48MGTABLET / ORAL2017-09-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200884-002FENOFIBRATE145MGTABLET / ORALAB2017-09-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200884-001FENOFIBRATE48MGTABLET / ORAL2017-09-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200884-002FENOFIBRATE145MGTABLET / ORALAB2017-09-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200884-001FENOFIBRATE48MGTABLET / ORALAB2017-09-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200884-002FENOFIBRATE145MGTABLET / ORALAB2017-09-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200884-001FENOFIBRATE48MGTABLET / ORALAB2017-09-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200884-002FENOFIBRATE145MGTABLET / ORALAB2017-09-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200884-001FENOFIBRATE48MGTABLET / ORALAB2017-09-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200884-002FENOFIBRATE145MGTABLET / ORALAB2017-09-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200884-001FENOFIBRATE48MGTABLET / ORALAB2017-09-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200884-002FENOFIBRATE145MGTABLET / ORALAB2017-09-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200884-001FENOFIBRATE48MGTABLET / ORALAB2017-09-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A200884-002FENOFIBRATE145MGTABLET / ORALAB2017-09-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200884-001FENOFIBRATE48MGTABLET / ORALAB2017-09-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200884-002FENOFIBRATE145MGTABLET / ORALAB2017-09-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200884-001FENOFIBRATE48MGTABLET / ORALAB2017-09-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200884-002FENOFIBRATE145MGTABLET / ORALAB2017-09-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200884-001FENOFIBRATE48MGTABLET / ORALAB2017-09-071e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200884-002FENOFIBRATE145MGTABLET / ORALAB2017-09-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200884-001FENOFIBRATE48MGTABLET / ORALAB2017-09-078072bd15b7f6…
2024-05-31 18:47 UTC2024-05A200884-002FENOFIBRATE145MGTABLET / ORALAB2017-09-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200884-001FENOFIBRATE48MGTABLET / ORALAB2017-09-075c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200884-002FENOFIBRATE145MGTABLET / ORALAB2017-09-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A200884-001FENOFIBRATE48MGTABLET / ORALAB2017-09-075d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A200884-002FENOFIBRATE145MGTABLET / ORALAB2017-09-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A200884-001FENOFIBRATE48MGTABLET / ORALAB2017-09-074b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A200884-002FENOFIBRATE145MGTABLET / ORALAB2017-09-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A200884-001FENOFIBRATE48MGTABLET / ORALAB2017-09-0774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A200884-002FENOFIBRATE145MGTABLET / ORALAB2017-09-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A200884-001FENOFIBRATE48MGTABLET / ORALAB2017-09-07bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A200884-002FENOFIBRATE145MGTABLET / ORALAB2017-09-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A200884-001FENOFIBRATE48MGTABLET / ORALAB2017-09-07782e0a99824c…
2021-12-28 21:50 UTC2021-12A200884-002FENOFIBRATE145MGTABLET / ORALAB2017-09-07782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 72 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200884-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200884-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200884-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200884-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200884-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200884-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200884-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200884-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200884-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200884-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200884-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A200884-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200884-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200884-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200884-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200884-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200884-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200884-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200884-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A200884-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200884-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200884-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A200884-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A200884-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A200884-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A200884-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A200884-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A200884-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A200884-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A200884-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A200884-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A200884-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A200884-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A200884-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A200884-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A200884-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A200884-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A200884-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A200884-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A200884-002AB1c0c555d07b60…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
71335-1292-12025-03-28These highlights do not include all the information needed to use FENOFIBRATE TABLETS safely and effectively. See full prescribing information for FENOFIBRATE TABLETS. FENOFIBRATE tablet, for oral use Initial U.S. Approval: 1993
71335-1292-22025-03-28These highlights do not include all the information needed to use FENOFIBRATE TABLETS safely and effectively. See full prescribing information for FENOFIBRATE TABLETS. FENOFIBRATE tablet, for oral use Initial U.S. Approval: 1993
71335-1292-32025-03-28These highlights do not include all the information needed to use FENOFIBRATE TABLETS safely and effectively. See full prescribing information for FENOFIBRATE TABLETS. FENOFIBRATE tablet, for oral use Initial U.S. Approval: 1993
71335-1292-12024-01-30These highlights do not include all the information needed to use FENOFIBRATE TABLETS safely and effectively. See full prescribing information for FENOFIBRATE TABLETS. FENOFIBRATE tablet, for oral use Initial U.S. Approval: 1993
71335-1292-22024-01-30These highlights do not include all the information needed to use FENOFIBRATE TABLETS safely and effectively. See full prescribing information for FENOFIBRATE TABLETS. FENOFIBRATE tablet, for oral use Initial U.S. Approval: 1993
71335-1292-32024-01-30These highlights do not include all the information needed to use FENOFIBRATE TABLETS safely and effectively. See full prescribing information for FENOFIBRATE TABLETS. FENOFIBRATE tablet, for oral use Initial U.S. Approval: 1993

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FenofibrateFENOFIBRATENorthwind Health Company, LLCf2f46239-951d-fc0e-e053-2995a90ae9792026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200884
application number: ANDA200884
FenofibrateFENOFIBRATEBryant Ranch Prepack3db58c5c-b862-4871-b3f9-597aaeba56c42025-03-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200884
application number: ANDA200884
FenofibrateFENOFIBRATESun Pharmaceutical Industries, Inc.125bbd7e-86a2-4209-90a5-ad353e572d1b2025-01-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200884
application number: ANDA200884
FenofibrateFENOFIBRATEA-S Medication Solutions06870192-c92a-40c7-a619-efda0c0063012023-04-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200884
application number: ANDA200884

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1292-17133512920130 TABLET, FILM COATED in 1 BOTTLE (71335-1292-1) 2022-02-110000-00-00NoNoCurrent
71335-1292-27133512920290 TABLET, FILM COATED in 1 BOTTLE (71335-1292-2) 2022-02-110000-00-00NoNoCurrent
71335-1292-37133512920328 TABLET, FILM COATED in 1 BOTTLE (71335-1292-3) 2022-02-110000-00-00NoNoCurrent