Fenofibrate

Product NDC
63187-940
11-digit product format
631870940
Labeler code
63187
Product ID
63187-940_09fb6f73-a2b3-4258-9642-cadabc64f827
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fenofibrate
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
NDA021656
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2016-02-09
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
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63187-940DDiscontinued by firm2026-08-10
excluded packagepackage63187-94063187-940-30DDiscontinued by firm2026-08-10
excluded packagepackage63187-94063187-940-60DDiscontinued by firm2026-08-10
excluded packagepackage63187-94063187-940-90DDiscontinued 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 1 · 8 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 packagepackage63187-940-90d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63187-940-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63187-940-60d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63187-940-90f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63187-940-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63187-940-60f5e01cc5f278…a2eaf40c39c3…

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
N021656-001TRICORFENOFIBRATE48MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2004-11-05
N021656-002TRICORFENOFIBRATE145MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2004-11-05

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 UTC2026-02N021656-001TRICOR48MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2004-11-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021656-002TRICOR145MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2004-11-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021656-001TRICOR48MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2004-11-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021656-002TRICOR145MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2004-11-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08N021656-001TRICOR48MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2004-11-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021656-002TRICOR145MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2004-11-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021656-001TRICOR48MGTABLET / ORALRLD2004-11-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021656-002TRICOR145MGTABLET / ORALRLD2004-11-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021656-001TRICOR48MGTABLET / ORALRLD2004-11-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021656-002TRICOR145MGTABLET / ORALRLD2004-11-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021656-001TRICOR48MGTABLET / ORALRLD2004-11-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021656-002TRICOR145MGTABLET / ORALRLD2004-11-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021656-001TRICOR48MGTABLET / ORALRLD2004-11-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021656-002TRICOR145MGTABLET / ORALRLD2004-11-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021656-001TRICOR48MGTABLET / ORALRLD2004-11-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021656-002TRICOR145MGTABLET / ORALRLD2004-11-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021656-001TRICOR48MGTABLET / ORALRLD2004-11-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021656-002TRICOR145MGTABLET / ORALRLD2004-11-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021656-001TRICOR48MGTABLET / ORALRLD2004-11-05d06236e962d9…
2024-10-29 15:01 UTC2024-10N021656-002TRICOR145MGTABLET / ORALRLD2004-11-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021656-001TRICOR48MGTABLET / ORALABRLD2004-11-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021656-002TRICOR145MGTABLET / ORALRLD2004-11-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021656-001TRICOR48MGTABLET / ORALABRLD2004-11-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021656-002TRICOR145MGTABLET / ORALRLD2004-11-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021656-001TRICOR48MGTABLET / ORALABRLD2004-11-051e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021656-002TRICOR145MGTABLET / ORALRLD2004-11-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021656-001TRICOR48MGTABLET / ORALABRLD2004-11-058072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021656-002TRICOR145MGTABLET / ORALRLD2004-11-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021656-001TRICOR48MGTABLET / ORALABRLD2004-11-055c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021656-002TRICOR145MGTABLET / ORALABRLD, RS2004-11-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021656-001TRICOR48MGTABLET / ORALABRLD2004-11-055d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021656-002TRICOR145MGTABLET / ORALABRLD, RS2004-11-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021656-001TRICOR48MGTABLET / ORALABRLD2004-11-054b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021656-002TRICOR145MGTABLET / ORALABRLD, RS2004-11-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021656-001TRICOR48MGTABLET / ORALABRLD2004-11-0574a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021656-002TRICOR145MGTABLET / ORALABRLD, RS2004-11-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021656-001TRICOR48MGTABLET / ORALABRLD2004-11-05bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021656-002TRICOR145MGTABLET / ORALABRLD, RS2004-11-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021656-001TRICOR48MGTABLET / ORALABRLD2004-11-05782e0a99824c…
2021-12-28 21:50 UTC2021-12N021656-002TRICOR145MGTABLET / ORALABRLD, RS2004-11-05782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 56 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021656-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021656-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021656-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021656-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021656-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021656-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021656-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021656-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021656-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021656-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021656-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021656-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021656-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021656-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021656-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12N021656-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021656-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021656-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N021656-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021656-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021656-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021656-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021656-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021656-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021656-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12N021656-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N021656-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09N021656-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N021656-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07N021656-002AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021656-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021656-002AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021656-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02N021656-002AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021656-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12N021656-002AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021656-001AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021656-002AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021656-001AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021656-002AB19b2671bbb829…

Observed Orange Book patent history#

Patent history page 1 of 3 · 108 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021656-00172762492023-02-21Drug product5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021656-00173208022023-02-21U-8475c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021656-00272762492023-02-21Drug product5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021656-00273208022023-02-21U-8475c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021656-00172762492023-02-21Drug product5d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021656-00173208022023-02-21U-8475d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021656-00272762492023-02-21Drug product5d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021656-00273208022023-02-21U-8475d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021656-00172762492023-02-21Drug product4b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021656-00173208022023-02-21U-8474b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021656-00272762492023-02-21Drug product4b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021656-00273208022023-02-21U-8474b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021656-00163759862020-09-21U-615Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021656-00172762492023-02-21Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021656-00173208022023-02-21U-84774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021656-00263759862020-09-21U-615Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021656-00272762492023-02-21Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021656-00273208022023-02-21U-84774a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021656-00172762492023-02-21Drug productbb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021656-00173208022023-02-21U-847bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021656-00272762492023-02-21Drug productbb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021656-00273208022023-02-21U-847bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021656-00172762492023-02-21Drug product782e0a99824c…
2021-12-28 21:50 UTC2021-12N021656-00173208022023-02-21U-847782e0a99824c…
2021-12-28 21:50 UTC2021-12N021656-00272762492023-02-21Drug product782e0a99824c…
2021-12-28 21:50 UTC2021-12N021656-00273208022023-02-21U-847782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021656-00172762492023-02-21Drug product87673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021656-00173208022023-02-21U-84787673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021656-00272762492023-02-21Drug product87673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021656-00273208022023-02-21U-84787673890dc5c…
2021-03-12 10:30 UTC2021-03N021656-00172762492023-02-21Drug product5aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021656-00173208022023-02-21U-8475aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021656-00272762492023-02-21Drug product5aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021656-00273208022023-02-21U-8475aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021656-00163759862020-09-21U-615Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021656-00172762492023-02-21Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021656-00173208022023-02-21U-8478869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021656-00263759862020-09-21U-615Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021656-00272762492023-02-21Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021656-00273208022023-02-21U-8478869cabd3fbd…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-940-90EA - Each63187-9406f068e1b-4d2a-4f80-9b9d-77ab5f0a2caf12018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-940FENOFIBRATE TABLET [PROFICIENT RX LP]3Legacy NDC20191108_ba12f441-6ace-47d8-9ba5-4408756ac17e.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TricorFENOFIBRATEA-S Medication Solutions84b2af1b-365e-4723-ac5f-bc826ec477722024-04-29Warnings, Adverse reactionsExact identifier
application applno (NDA): 021656
application number: NDA021656

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-940-306318709403030 TABLET in 1 BOTTLE (63187-940-30) 30 tablet2017-12-010000-00-00NoNoCurrent
63187-940-606318709406060 TABLET in 1 BOTTLE (63187-940-60) 60 tablet2017-12-010000-00-00NoNoCurrent
63187-940-906318709409090 TABLET in 1 BOTTLE (63187-940-90) 90 tablet2017-12-010000-00-00NoNoCurrent