FIBRICOR

Product NDC: 71511-501
Requested package NDC: 71511-501-30
11-digit product format: 715110501
Labeler code: 71511
Product ID: 71511-501_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: 35 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#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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	71511-501	71511-501-30	D	Discontinued by firm		2026-07-31

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-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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	N022418-001	FIBRICOR	35MG	TABLET / ORAL		RLD	2009-08-14	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022418-002	FIBRICOR	105MG	TABLET / ORAL		RLD	2009-08-14	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-08-01 22:54:32	2026-06	N022418-001	7569612	2027-08-20	U-1000		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022418-001	7741373	2027-08-20	U-1059		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022418-001	7741374	2027-08-20	U-1061		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022418-001	7741374	2027-08-20	U-1060		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022418-001	7915247	2027-08-20	U-1061	2011-03-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022418-001	7915247	2027-08-20	U-1059	2011-03-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022418-001	7915247	2027-08-20	U-1000	2011-03-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022418-002	7569612	2027-08-20	U-1000		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022418-002	7741373	2027-08-20	U-1059		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022418-002	7741374	2027-08-20	U-1061		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022418-002	7741374	2027-08-20	U-1060		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022418-002	7915247	2027-08-20	U-1000		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022418-002	7915247	2027-08-20	U-1059		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N022418-002	7915247	2027-08-20	U-1061		`a50c72e98297…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71511-501-30	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
71511-501-30	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
71511-501-30	EA - Each	71511-501	9e025b8b-0729-48fa-b37b-c1ced9178ab0	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
71511-501-30	71511050130	30 TABLET in 1 BOTTLE, PLASTIC (71511-501-30)	30 tablet	2019-03-15	0000-00-00	No	No	Current