FENOFIBRATE

Product NDC: 71335-2629
11-digit product format: 713352629
Labeler code: 71335
Product ID: 71335-2629_338d03b2-c34f-6e24-e063-6394a90a3c39
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: fenofibrate
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA217732
Marketing category: ANDA
Marketing start: 2023-09-07
Substance: FENOFIBRATE
Active strength: 120 mg/1
Pharmacologic classes: Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

openFDA Listing Details

Product ID: 71335-2629_338d03b2-c34f-6e24-e063-6394a90a3c39
SPL ID: 338d03b2-c34f-6e24-e063-6394a90a3c39
Product type: HUMAN PRESCRIPTION DRUG
Finished product: Yes
Brand name base: FENOFIBRATE
Generic name: fenofibrate
Dosage form: TABLET
Route: ORAL
Marketing start: 2023-09-07
Marketing category: ANDA
Application number: ANDA217732
Pharmacologic classes: Peroxisome Proliferator Receptor alpha Agonist [EPC]
Listing expiration: 2026-12-31

openFDA Active Ingredients

Ingredient	Strength
FENOFIBRATE	120 mg/1

openFDA Harmonized Identifiers

Field	Values
Unii	U202363UOS
Rxcui	749802, 749804
Spl Set Id	338d03b2-c34e-6e24-e063-6394a90a3c39
Manufacturer Name	Bryant Ranch Prepack

openFDA Package Details

Package NDC	Description	Marketing start	Sample
71335-2629-1	90 TABLET in 1 BOTTLE (71335-2629-1)	2025-04-14	No

Related Records

Related UNII Ingredients

UNII	Preferred term	Registry number	Matched term
U202363UOS	FENOFIBRATE	49562-28-9	FENOFIBRATE

Packages

Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71335-2629-1	71335262901	90 TABLET in 1 BOTTLE (71335-2629-1)	90 tablet	2025-04-14	No	No	Historical

Related DailyMed Labels

Title	Manufacturer	Effective date	Type	Version
FENOFIBRATE	Bryant Ranch Prepack	2025-04-24	HUMAN PRESCRIPTION DRUG LABEL	1