FIBRICOR

Product NDC: 71511-502
11-digit product format: 715110502
Labeler code: 71511
Product ID: 71511-502_f1aa0095-4a2d-42cf-b4f5-b88e0f55a4e4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fenofibric Acid
Dosage form: TABLET
Route: ORAL
Labeler: Athena Bioscience, LLC
Application: NDA022418
Marketing category: NDA
Marketing start: 2017-08-05
Marketing end: 0000-00-00
Substance: FENOFIBRIC ACID
Active strength: 105 mg/1
Pharmacologic classes: Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	71511-502		D	Discontinued by firm		2026-08-17
excluded package	package	71511-502	71511-502-30	D	Discontinued by firm		2026-08-17

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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71511-502-30	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71511-502-30	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71511-502-30	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71511-502-30	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71511-502-30	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71511-502-30	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71511-502-30	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71511-502-30	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71511-502-30	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	71511-502-30	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	71511-502-30	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	71511-502-30	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	71511-502-30	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	71511-502-30	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	71511-502-30	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022418-001	FIBRICOR	FENOFIBRIC ACID	35MG	TABLET / ORAL		RLD	2009-08-14
N022418-002	FIBRICOR	FENOFIBRIC ACID	105MG	TABLET / ORAL		RLD	2009-08-14

Orange Book patents#

Current patent rows page 1 of 1 · 14 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Submission date
N022418-001	7569612	2027-08-20	U-1000
N022418-001	7741373	2027-08-20	U-1059
N022418-001	7741374	2027-08-20	U-1060
N022418-001	7741374	2027-08-20	U-1061
N022418-001	7915247	2027-08-20	U-1000	2011-03-30
N022418-001	7915247	2027-08-20	U-1059	2011-03-30
N022418-001	7915247	2027-08-20	U-1061	2011-03-30
N022418-002	7569612	2027-08-20	U-1000
N022418-002	7741373	2027-08-20	U-1059
N022418-002	7741374	2027-08-20	U-1060
N022418-002	7741374	2027-08-20	U-1061
N022418-002	7915247	2027-08-20	U-1000
N022418-002	7915247	2027-08-20	U-1059
N022418-002	7915247	2027-08-20	U-1061

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 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022418-001	FIBRICOR	35MG	TABLET / ORAL	RLD	2009-08-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022418-002	FIBRICOR	105MG	TABLET / ORAL	RLD	2009-08-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022418-001	FIBRICOR	35MG	TABLET / ORAL	RLD	2009-08-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022418-002	FIBRICOR	105MG	TABLET / ORAL	RLD	2009-08-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022418-001	FIBRICOR	35MG	TABLET / ORAL	RLD	2009-08-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022418-002	FIBRICOR	105MG	TABLET / ORAL	RLD	2009-08-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022418-001	FIBRICOR	35MG	TABLET / ORAL	RLD	2009-08-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022418-002	FIBRICOR	105MG	TABLET / ORAL	RLD, RS	2009-08-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022418-001	FIBRICOR	35MG	TABLET / ORAL	RLD	2009-08-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022418-002	FIBRICOR	105MG	TABLET / ORAL	RLD	2009-08-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022418-001	FIBRICOR	35MG	TABLET / ORAL	RLD	2009-08-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022418-002	FIBRICOR	105MG	TABLET / ORAL	RLD	2009-08-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022418-001	FIBRICOR	35MG	TABLET / ORAL	RLD	2009-08-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022418-002	FIBRICOR	105MG	TABLET / ORAL	RLD	2009-08-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022418-001	FIBRICOR	35MG	TABLET / ORAL	RLD	2009-08-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022418-002	FIBRICOR	105MG	TABLET / ORAL	RLD	2009-08-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022418-001	FIBRICOR	35MG	TABLET / ORAL	RLD	2009-08-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022418-002	FIBRICOR	105MG	TABLET / ORAL	RLD	2009-08-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022418-001	FIBRICOR	35MG	TABLET / ORAL	RLD	2009-08-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022418-002	FIBRICOR	105MG	TABLET / ORAL	RLD	2009-08-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022418-001	FIBRICOR	35MG	TABLET / ORAL	RLD	2009-08-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022418-002	FIBRICOR	105MG	TABLET / ORAL	RLD	2009-08-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022418-001	FIBRICOR	35MG	TABLET / ORAL	RLD	2009-08-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022418-002	FIBRICOR	105MG	TABLET / ORAL	RLD	2009-08-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022418-001	FIBRICOR	35MG	TABLET / ORAL	RLD	2009-08-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022418-002	FIBRICOR	105MG	TABLET / ORAL	RLD	2009-08-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022418-001	FIBRICOR	35MG	TABLET / ORAL	RLD	2009-08-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022418-002	FIBRICOR	105MG	TABLET / ORAL	RLD	2009-08-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022418-001	FIBRICOR	35MG	TABLET / ORAL	RLD	2009-08-14	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022418-002	FIBRICOR	105MG	TABLET / ORAL	RLD	2009-08-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022418-001	FIBRICOR	35MG	TABLET / ORAL	RLD	2009-08-14	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022418-002	FIBRICOR	105MG	TABLET / ORAL	RLD, RS	2009-08-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022418-001	FIBRICOR	35MG	TABLET / ORAL	RLD	2009-08-14	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022418-002	FIBRICOR	105MG	TABLET / ORAL	RLD, RS	2009-08-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022418-001	FIBRICOR	35MG	TABLET / ORAL	RLD	2009-08-14	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022418-002	FIBRICOR	105MG	TABLET / ORAL	RLD, RS	2009-08-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022418-001	FIBRICOR	35MG	TABLET / ORAL	RLD	2009-08-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022418-002	FIBRICOR	105MG	TABLET / ORAL	RLD, RS	2009-08-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022418-001	FIBRICOR	35MG	TABLET / ORAL	RLD	2009-08-14	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022418-002	FIBRICOR	105MG	TABLET / ORAL	RLD, RS	2009-08-14	`bb7c543d1eb4…`

Observed Orange Book patent history#

Patent history page 1 of 15 · 588 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022418-001	7569612	2027-08-20	U-1000		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022418-001	7741373	2027-08-20	U-1059		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022418-001	7741374	2027-08-20	U-1061		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022418-001	7741374	2027-08-20	U-1060		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022418-001	7915247	2027-08-20	U-1061	2011-03-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022418-001	7915247	2027-08-20	U-1059	2011-03-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022418-001	7915247	2027-08-20	U-1000	2011-03-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022418-002	7569612	2027-08-20	U-1000		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022418-002	7741373	2027-08-20	U-1059		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022418-002	7741374	2027-08-20	U-1061		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022418-002	7741374	2027-08-20	U-1060		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022418-002	7915247	2027-08-20	U-1000		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022418-002	7915247	2027-08-20	U-1059		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022418-002	7915247	2027-08-20	U-1061		`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022418-001	7569612	2027-08-20	U-1000		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022418-001	7741373	2027-08-20	U-1059		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022418-001	7741374	2027-08-20	U-1061		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022418-001	7741374	2027-08-20	U-1060		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022418-001	7915247	2027-08-20	U-1061	2011-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022418-001	7915247	2027-08-20	U-1059	2011-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022418-001	7915247	2027-08-20	U-1000	2011-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022418-002	7569612	2027-08-20	U-1000		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022418-002	7741373	2027-08-20	U-1059		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022418-002	7741374	2027-08-20	U-1061		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022418-002	7741374	2027-08-20	U-1060		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022418-002	7915247	2027-08-20	U-1000		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022418-002	7915247	2027-08-20	U-1059		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022418-002	7915247	2027-08-20	U-1061		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022418-001	7569612	2027-08-20	U-1000		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022418-001	7741373	2027-08-20	U-1059		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022418-001	7741374	2027-08-20	U-1061		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022418-001	7741374	2027-08-20	U-1060		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022418-001	7915247	2027-08-20	U-1061	2011-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022418-001	7915247	2027-08-20	U-1059	2011-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022418-001	7915247	2027-08-20	U-1000	2011-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022418-002	7569612	2027-08-20	U-1000		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022418-002	7741373	2027-08-20	U-1059		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022418-002	7741374	2027-08-20	U-1061		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022418-002	7741374	2027-08-20	U-1060		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022418-002	7915247	2027-08-20	U-1000		`31067a03dcf5…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71511-502-30	2025-02-17	C162847	48780-1	f386c64a-1121-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use FIBRICOR ® (fenofibric acid) Tablets safely and effectively. See full prescribing information for FIBRICOR ® . FIBRICOR ® (fenofibric acid) Tablets, for oral use Initial U.S. Approval: 1993
71511-502-30	2023-01-30	C162847	48780-1	f386c64a-1121-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use FIBRICOR ® (fenofibric acid) Tablets safely and effectively. See full prescribing information for FIBRICOR ® . FIBRICOR ® (fenofibric acid) Tablets, for oral use Initial U.S. Approval: 1993

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71511-502-30	EA - Each	71511-502	727519e6-50ec-4fbe-940f-610ee82f65e6	1	2019-08-06

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
BGF9MN2HU1	FENOFIBRIC ACID	42017-89-0	FENOFIBRIC ACID

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71511-502-30	71511050230	30 TABLET in 1 BOTTLE, PLASTIC (71511-502-30)	30 tablet	2019-03-15	0000-00-00	No	No	Current