Fenofibrate

Product NDC: 63187-760
Requested package NDC: 63187-760-30
11-digit product format: 631870760
Labeler code: 63187
Product ID: 63187-760_ce938712-eb6a-4c1b-b917-9dd150f4c416
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fenofibrate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA076635
Marketing category: ANDA
Marketing start: 2006-05-10
Marketing end: 0000-00-00
Substance: FENOFIBRATE
Active strength: 160 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	63187-760	63187-760-30	D	Discontinued by firm		2026-10-05

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 date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63187-760	63187-760-30	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63187-760	63187-760-30	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A076635-001	FENOFIBRATE	FENOFIBRATE	54MG	TABLET / ORAL	2005-10-31
A076635-002	FENOFIBRATE	FENOFIBRATE	107MG	TABLET / ORAL	2005-10-31
A076635-003	FENOFIBRATE	FENOFIBRATE	160MG	TABLET / ORAL	2005-10-31

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 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A076635-001	FENOFIBRATE	54MG	TABLET / ORAL		2005-10-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076635-002	FENOFIBRATE	107MG	TABLET / ORAL		2005-10-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076635-003	FENOFIBRATE	160MG	TABLET / ORAL		2005-10-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076635-001	FENOFIBRATE	54MG	TABLET / ORAL		2005-10-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076635-002	FENOFIBRATE	107MG	TABLET / ORAL		2005-10-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076635-003	FENOFIBRATE	160MG	TABLET / ORAL		2005-10-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076635-001	FENOFIBRATE	54MG	TABLET / ORAL		2005-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076635-002	FENOFIBRATE	107MG	TABLET / ORAL		2005-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076635-003	FENOFIBRATE	160MG	TABLET / ORAL		2005-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076635-001	FENOFIBRATE	54MG	TABLET / ORAL		2005-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076635-002	FENOFIBRATE	107MG	TABLET / ORAL		2005-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076635-003	FENOFIBRATE	160MG	TABLET / ORAL		2005-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076635-001	FENOFIBRATE	54MG	TABLET / ORAL		2005-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076635-002	FENOFIBRATE	107MG	TABLET / ORAL		2005-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076635-003	FENOFIBRATE	160MG	TABLET / ORAL		2005-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076635-001	FENOFIBRATE	54MG	TABLET / ORAL		2005-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076635-002	FENOFIBRATE	107MG	TABLET / ORAL		2005-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076635-003	FENOFIBRATE	160MG	TABLET / ORAL		2005-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076635-001	FENOFIBRATE	54MG	TABLET / ORAL		2005-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076635-002	FENOFIBRATE	107MG	TABLET / ORAL		2005-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076635-003	FENOFIBRATE	160MG	TABLET / ORAL		2005-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076635-001	FENOFIBRATE	54MG	TABLET / ORAL		2005-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076635-002	FENOFIBRATE	107MG	TABLET / ORAL		2005-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076635-003	FENOFIBRATE	160MG	TABLET / ORAL		2005-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076635-001	FENOFIBRATE	54MG	TABLET / ORAL		2005-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076635-002	FENOFIBRATE	107MG	TABLET / ORAL		2005-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076635-003	FENOFIBRATE	160MG	TABLET / ORAL		2005-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076635-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2005-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076635-002	FENOFIBRATE	107MG	TABLET / ORAL		2005-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076635-003	FENOFIBRATE	160MG	TABLET / ORAL	AB	2005-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076635-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2005-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076635-002	FENOFIBRATE	107MG	TABLET / ORAL		2005-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076635-003	FENOFIBRATE	160MG	TABLET / ORAL	AB	2005-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076635-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2005-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076635-002	FENOFIBRATE	107MG	TABLET / ORAL		2005-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076635-003	FENOFIBRATE	160MG	TABLET / ORAL	AB	2005-10-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076635-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2005-10-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076635-002	FENOFIBRATE	107MG	TABLET / ORAL		2005-10-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076635-003	FENOFIBRATE	160MG	TABLET / ORAL	AB	2005-10-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076635-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2005-10-31	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076635-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076635-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076635-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076635-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076635-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076635-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076635-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076635-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076635-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076635-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076635-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076635-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076635-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076635-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076635-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076635-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076635-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076635-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076635-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076635-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076635-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076635-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076635-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076635-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076635-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076635-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076635-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076635-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076635-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A076635-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076635-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A076635-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076635-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A076635-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076635-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076635-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076635-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076635-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076635-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076635-003	AB	1	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63187-760-30	EA - Each	63187-760	aa038e63-f0c9-4de2-9b67-bd884603f2c3	1	2018-02-20
63187-760-90	EA - Each	63187-760	ccef204c-2861-4ad3-a8dc-5465863ea42e	1	2016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-760	FENOFIBRATE TABLET, FILM COATED [PROFICIENT RX LP]	3	Legacy NDC	20191121_6ec96fe8-2538-4f0f-8c70-37f8e3615338.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
U202363UOS	FENOFIBRATE	49562-28-9	FENOFIBRATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63187-760-30	63187076030	30 TABLET, FILM COATED in 1 BOTTLE (63187-760-30)	2016-11-01	0000-00-00	No	No	Current