FIBRICOR

Product NDC: 13310-101
11-digit product format: 133100101
Labeler code: 13310
Product ID: 13310-101_26bcf80c-8314-4e10-b32c-452dbce94f7a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fenofibric Acid
Dosage form: TABLET
Route: ORAL
Labeler: AR Scientific, Inc.
Application: NDA022418
Marketing category: NDA
Marketing start: 2009-08-14
Marketing end: 0000-00-00
Substance: FENOFIBRIC ACID
Active strength: 35 mg/1
Pharmacologic classes: Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 8 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	13310-101		I	Inactivated by FDA	2026-07-31
excluded package	package	13310-101	13310-101-01	I	Inactivated by FDA	2026-07-31
excluded package	package	13310-101	13310-101-03	I	Inactivated by FDA	2026-07-31
excluded package	package	13310-101	13310-101-05	I	Inactivated by FDA	2026-07-31
excluded package	package	13310-101	13310-101-06	I	Inactivated by FDA	2026-07-31
excluded package	package	13310-101	13310-101-07	I	Inactivated by FDA	2026-07-31
excluded package	package	13310-101	13310-101-10	I	Inactivated by FDA	2026-07-31
excluded package	package	13310-101	13310-101-90	I	Inactivated by FDA	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…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
193bb7da-5c03-8f95-9048-23ef403846b0	Product name	3	20250616
fa35fb9a-7146-716b-13c8-bc1f60030232	Product name	9	20250114
cfc78bfa-7d55-47e5-aeb7-71cd79f5ca07	Product name	8	20231212
53d5b6b7-785a-4500-9460-263c7f8424b8	Product name	5	20210105
ed9d55d4-85bd-0ee7-5b4a-b705646a3a66	Product name	9	20200708

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
13310-101-01	2019-11-27	C162847	48780-1	9855d018-e8cd-cd31-e053-dbdaa90ab51a	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
13310-101-03	2019-11-27	C162847	48780-1	9855d018-e8cd-cd31-e053-dbdaa90ab51a	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
13310-101-05	2019-11-27	C162847	48780-1	9855d018-e8cd-cd31-e053-dbdaa90ab51a	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
13310-101-06	2019-11-27	C162847	48780-1	9855d018-e8cd-cd31-e053-dbdaa90ab51a	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
13310-101-07	2019-11-27	C162847	48780-1	9855d018-e8cd-cd31-e053-dbdaa90ab51a	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
13310-101-10	2019-11-27	C162847	48780-1	9855d018-e8cd-cd31-e053-dbdaa90ab51a	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
13310-101-90	2019-11-27	C162847	48780-1	9855d018-e8cd-cd31-e053-dbdaa90ab51a	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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
13310-101-01	FIBRICOR	100 in 1 BOTTLE, PLASTIC	TABLET	100	13
13310-101-03	FIBRICOR	250 in 1 BOTTLE, PLASTIC	TABLET	250	13
13310-101-05	FIBRICOR	500 in 1 BOTTLE, PLASTIC	TABLET	500	13
13310-101-06	FIBRICOR	60 in 1 BOTTLE, PLASTIC	TABLET	60	13
13310-101-07	FIBRICOR	30 in 1 BOTTLE, PLASTIC	TABLET	30	13
13310-101-10	FIBRICOR	1000 in 1 BOTTLE, PLASTIC	TABLET	1000	13
13310-101-90	FIBRICOR	90 in 1 BOTTLE, PLASTIC	TABLET	90	13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
13310-101-07	EA - Each	13310-101	8a0c41a0-b0ad-4b86-b9f9-8d76f1a68378	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Fenofibric Acid	ACTIVE INGREDIENT	BGF9MN2HU1	FIBRICOR (FENOFIBRIC ACID) TABLET [AR SCIENTIFIC, INC.]	13
Fenofibric Acid	ACTIVE MOIETY	BGF9MN2HU1	FIBRICOR (FENOFIBRIC ACID) TABLET [AR SCIENTIFIC, INC.]	13
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	FIBRICOR (FENOFIBRIC ACID) TABLET [AR SCIENTIFIC, INC.]	13
copovidone K25-31	INACTIVE INGREDIENT	D9C330MD8B	FIBRICOR (FENOFIBRIC ACID) TABLET [AR SCIENTIFIC, INC.]	13
crospovidone	INACTIVE INGREDIENT	68401960MK	FIBRICOR (FENOFIBRIC ACID) TABLET [AR SCIENTIFIC, INC.]	13
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	FIBRICOR (FENOFIBRIC ACID) TABLET [AR SCIENTIFIC, INC.]	13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
13310-101	FIBRICOR (FENOFIBRIC ACID) TABLET [AR SCIENTIFIC, INC.]	13	Legacy NDC, 7 package rows	20130321_86c49aff-0a4a-46b5-ac6e-26789bf17c9b.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
860880	fenofibric acid 105 MG Oral Tablet	PSN	86c49aff-0a4a-46b5-ac6e-26789bf17c9b	13
860886	fenofibric acid 35 MG Oral Tablet	PSN	86c49aff-0a4a-46b5-ac6e-26789bf17c9b	13
860884	FIBRICOR 105 MG Oral Tablet	PSN	86c49aff-0a4a-46b5-ac6e-26789bf17c9b	13
860888	FIBRICOR 35 MG Oral Tablet	PSN	86c49aff-0a4a-46b5-ac6e-26789bf17c9b	13
860884	fenofibric acid 105 MG Oral Tablet [Fibricor]	SBD	86c49aff-0a4a-46b5-ac6e-26789bf17c9b	13
860888	fenofibric acid 35 MG Oral Tablet [Fibricor]	SBD	86c49aff-0a4a-46b5-ac6e-26789bf17c9b	13
860880	fenofibric acid 105 MG Oral Tablet	SCD	86c49aff-0a4a-46b5-ac6e-26789bf17c9b	13
860886	fenofibric acid 35 MG Oral Tablet	SCD	86c49aff-0a4a-46b5-ac6e-26789bf17c9b	13
860884	Fibricor (fenofibric acid 105 MG) Oral Tablet	SY	86c49aff-0a4a-46b5-ac6e-26789bf17c9b	13
860888	Fibricor (fenofibric acid 35 MG) Oral Tablet	SY	86c49aff-0a4a-46b5-ac6e-26789bf17c9b	13
860884	Fibricor 105 MG Oral Tablet	SY	86c49aff-0a4a-46b5-ac6e-26789bf17c9b	13
860888	Fibricor 35 MG Oral Tablet	SY	86c49aff-0a4a-46b5-ac6e-26789bf17c9b	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
13310-101-01	13310010101	100 in 1 BOTTLE, PLASTIC	Historical
13310-101-03	13310010103	250 in 1 BOTTLE, PLASTIC	Historical
13310-101-05	13310010105	500 in 1 BOTTLE, PLASTIC	Historical
13310-101-06	13310010106	60 in 1 BOTTLE, PLASTIC	Historical
13310-101-07	13310010107	30 in 1 BOTTLE, PLASTIC	Historical
13310-101-10	13310010110	1000 in 1 BOTTLE, PLASTIC	Historical
13310-101-90	13310010190	90 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
FIBRICOR	AR Scientific, Inc. \| Mutual Pharmaceutical Company, Inc.	2013-03-19	HUMAN PRESCRIPTION DRUG LABEL	13