Fenofibric Acid

Product NDC: 72834-105
Requested package NDC: 72834-105-15
11-digit product format: 728340105
Labeler code: 72834
Product ID: 72834-105_9793c4bf-c687-4a0a-b356-6f04d521585a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fenofibric Acid
Dosage form: TABLET
Route: ORAL
Labeler: Sarras Health, LLC
Application: NDA022418
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2019-06-27
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#

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	72834-105	72834-105-15	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
72834-105-15	2023-01-30	C162847	48780-1	f386c649-9d10-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use fenofibric acid tablets safely and effectively. See full prescribing information for fenofibric acid tablets. 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
72834-105-15	Fenofibric Acid	15 in 1 BOTTLE, PLASTIC	TABLET	15		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72834-105-15	EA - Each	72834-105	706e4941-c5e7-4791-afc4-a9577a30de06	1	2019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72834-105	FENOFIBRIC ACID TABLET [SARRAS HEALTH, LLC]	5	Legacy NDC, 1 package rows	20220101_09310de5-1eaa-44ba-8d9b-2abc1ad1cc33.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	09310de5-1eaa-44ba-8d9b-2abc1ad1cc33	5
860886	fenofibric acid 35 MG Oral Tablet	PSN	09310de5-1eaa-44ba-8d9b-2abc1ad1cc33	5
860880	fenofibric acid 105 MG Oral Tablet	SCD	09310de5-1eaa-44ba-8d9b-2abc1ad1cc33	5
860886	fenofibric acid 35 MG Oral Tablet	SCD	09310de5-1eaa-44ba-8d9b-2abc1ad1cc33	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72834-105-15	72834010515	15 TABLET in 1 BOTTLE, PLASTIC (72834-105-15)	15 tablet	2019-06-27	0000-00-00	No	No	Current