FIBRICOR

Product NDC: 69916-105
11-digit product format: 699160105
Labeler code: 69916
Product ID: 69916-105_31112335-e6c0-4c10-b5db-8cf4c4c74d65
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fenofibric Acid
Dosage form: TABLET
Route: ORAL
Labeler: Tribute Pharmaceuticals US, Inc.
Application: NDA022418
Marketing category: NDA
Marketing start: 2015-07-30
Marketing end: 0000-00-00
Substance: FENOFIBRIC ACID
Active strength: 105 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.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	69916-105		I	Inactivated by FDA		2026-07-31
excluded package	package	69916-105	69916-105-07	I	Inactivated by FDA		2026-07-31
excluded package	package	69916-105	69916-105-10	I	Inactivated by FDA		2026-07-31
excluded package	package	69916-105	69916-105-30	I	Inactivated by FDA		2026-07-31
excluded package	package	69916-105	69916-105-90	I	Inactivated by FDA		2026-07-31

Orange Book products#

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#

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	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-1061
N022418-001	7741374	2027-08-20	U-1060
N022418-001	7915247	2027-08-20	U-1061		2011-03-30
N022418-001	7915247	2027-08-20	U-1059		2011-03-30
N022418-001	7915247	2027-08-20	U-1000		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-1061
N022418-002	7741374	2027-08-20	U-1060
N022418-002	7915247	2027-08-20	U-1000
N022418-002	7915247	2027-08-20	U-1059
N022418-002	7915247	2027-08-20	U-1061

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
69916-105-07	2020-01-31	C162847	48780-1	9d75b9cf-fcc8-f424-e053-dadaa90a57ce	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
69916-105-10	2020-01-31	C162847	48780-1	9d75b9cf-fcc8-f424-e053-dadaa90a57ce	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
69916-105-30	2020-01-31	C162847	48780-1	9d75b9cf-fcc8-f424-e053-dadaa90a57ce	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
69916-105-90	2020-01-31	C162847	48780-1	9d75b9cf-fcc8-f424-e053-dadaa90a57ce	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	Strength	SPL version
69916-105-07	FIBRICOR	7 in 1 BOTTLE, PLASTIC	TABLET	7		3
69916-105-10	FIBRICOR	1000 in 1 BOTTLE, PLASTIC	TABLET	1000		3
69916-105-30	FIBRICOR	30 in 1 BOTTLE, PLASTIC	TABLET	30		3
69916-105-90	FIBRICOR	90 in 1 BOTTLE, PLASTIC	TABLET	90		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69916-105-30	EA - Each	69916-105	fbf846af-9971-4521-a91d-cf87d8d27ac7	1	2016-04-04
69916-105-90	EA - Each	69916-105	ae0b70f6-77cc-40c9-9986-59a340ffd87b	1	2016-04-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
Fenofibric Acid	ACTIVE INGREDIENT	BGF9MN2HU1	FIBRICOR (FENOFIBRIC ACID) TABLET [TRIBUTE PHARMACEUTICALS US, INC.]	2
Fenofibric Acid	ACTIVE MOIETY	BGF9MN2HU1	FIBRICOR (FENOFIBRIC ACID) TABLET [TRIBUTE PHARMACEUTICALS US, INC.]	2
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	FIBRICOR (FENOFIBRIC ACID) TABLET [TRIBUTE PHARMACEUTICALS US, INC.]	2
Copovidone K25-31	INACTIVE INGREDIENT	D9C330MD8B	FIBRICOR (FENOFIBRIC ACID) TABLET [TRIBUTE PHARMACEUTICALS US, INC.]	2
crospovidone	INACTIVE INGREDIENT	68401960MK	FIBRICOR (FENOFIBRIC ACID) TABLET [TRIBUTE PHARMACEUTICALS US, INC.]	2
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	FIBRICOR (FENOFIBRIC ACID) TABLET [TRIBUTE PHARMACEUTICALS US, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69916-105	FIBRICOR (FENOFIBRIC ACID) TABLET [TRIBUTE PHARMACEUTICALS US, INC.]	3	Legacy NDC, 4 package rows	20160108_777b0c6b-cd25-454d-a35b-d2df9b44497f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
860880	fenofibric acid 105 MG Oral Tablet	PSN	777b0c6b-cd25-454d-a35b-d2df9b44497f	3
860886	fenofibric acid 35 MG Oral Tablet	PSN	777b0c6b-cd25-454d-a35b-d2df9b44497f	3
860884	FIBRICOR 105 MG Oral Tablet	PSN	777b0c6b-cd25-454d-a35b-d2df9b44497f	3
860888	FIBRICOR 35 MG Oral Tablet	PSN	777b0c6b-cd25-454d-a35b-d2df9b44497f	3
860884	fenofibric acid 105 MG Oral Tablet [Fibricor]	SBD	777b0c6b-cd25-454d-a35b-d2df9b44497f	3
860888	fenofibric acid 35 MG Oral Tablet [Fibricor]	SBD	777b0c6b-cd25-454d-a35b-d2df9b44497f	3
860880	fenofibric acid 105 MG Oral Tablet	SCD	777b0c6b-cd25-454d-a35b-d2df9b44497f	3
860886	fenofibric acid 35 MG Oral Tablet	SCD	777b0c6b-cd25-454d-a35b-d2df9b44497f	3
860884	Fibricor (fenofibric acid 105 MG) Oral Tablet	SY	777b0c6b-cd25-454d-a35b-d2df9b44497f	3
860888	Fibricor (fenofibric acid 35 MG) Oral Tablet	SY	777b0c6b-cd25-454d-a35b-d2df9b44497f	3
860884	Fibricor 105 MG Oral Tablet	SY	777b0c6b-cd25-454d-a35b-d2df9b44497f	3
860888	Fibricor 35 MG Oral Tablet	SY	777b0c6b-cd25-454d-a35b-d2df9b44497f	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
69916-105-07	69916010507	7 in 1 BOTTLE, PLASTIC	Historical
69916-105-10	69916010510	1000 in 1 BOTTLE, PLASTIC	Historical
69916-105-30	69916010530	30 in 1 BOTTLE, PLASTIC	Historical
69916-105-90	69916010590	90 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
FIBRICOR	Tribute Pharmaceuticals US, Inc. \| Mutual Pharmaceutical Company, Inc.	2016-01-08	HUMAN PRESCRIPTION DRUG LABEL	3