Fenofibrate

Product NDC: 61269-210
11-digit product format: 612690210
Labeler code: 61269
Product ID: 61269-210_8da243b2-fa62-4e6f-a064-12d15e0eda29
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: fenofibrate
Dosage form: CAPSULE
Route: ORAL
Labeler: H2-Pharma, LLC
Application: NDA021612
Marketing category: NDA
Marketing start: 2014-05-05
Marketing end: 0000-00-00
Substance: FENOFIBRATE
Active strength: 50 mg/1
Pharmacologic classes: Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag: E
Listing certified through: 2018-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	61269-210		D	Discontinued by firm		2026-10-05
excluded package	package	61269-210	61269-210-90	D	Discontinued by firm		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 26 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61269-210-90	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61269-210-90	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61269-210-90	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61269-210-90	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61269-210-90	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61269-210-90	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61269-210-90	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61269-210-90	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61269-210-90	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61269-210-90	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61269-210-90	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61269-210-90	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	61269-210-90	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N021612-001	LIPOFEN	FENOFIBRATE	50MG	CAPSULE / ORAL	RLD	2006-01-11
N021612-002	LIPOFEN	FENOFIBRATE	100MG	CAPSULE / ORAL	RLD	2006-01-11
N021612-003	LIPOFEN	FENOFIBRATE	150MG	CAPSULE / ORAL	RLD, RS	2006-01-11

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.

Product history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021612-001	LIPOFEN	50MG	CAPSULE / ORAL	RLD	2006-01-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021612-002	LIPOFEN	100MG	CAPSULE / ORAL	RLD	2006-01-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021612-003	LIPOFEN	150MG	CAPSULE / ORAL	RLD, RS	2006-01-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021612-001	LIPOFEN	50MG	CAPSULE / ORAL	RLD	2006-01-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021612-002	LIPOFEN	100MG	CAPSULE / ORAL	RLD	2006-01-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021612-003	LIPOFEN	150MG	CAPSULE / ORAL	RLD, RS	2006-01-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021612-001	LIPOFEN	50MG	CAPSULE / ORAL	RLD	2006-01-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021612-002	LIPOFEN	100MG	CAPSULE / ORAL	RLD	2006-01-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021612-003	LIPOFEN	150MG	CAPSULE / ORAL	RLD, RS	2006-01-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021612-001	LIPOFEN	50MG	CAPSULE / ORAL	RLD	2006-01-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021612-002	LIPOFEN	100MG	CAPSULE / ORAL		2006-01-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021612-003	LIPOFEN	150MG	CAPSULE / ORAL	RLD, RS	2006-01-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021612-001	LIPOFEN	50MG	CAPSULE / ORAL	RLD	2006-01-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021612-002	LIPOFEN	100MG	CAPSULE / ORAL		2006-01-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021612-003	LIPOFEN	150MG	CAPSULE / ORAL	RLD, RS	2006-01-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021612-001	LIPOFEN	50MG	CAPSULE / ORAL	RLD	2006-01-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021612-002	LIPOFEN	100MG	CAPSULE / ORAL		2006-01-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021612-003	LIPOFEN	150MG	CAPSULE / ORAL	RLD, RS	2006-01-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021612-001	LIPOFEN	50MG	CAPSULE / ORAL	RLD	2006-01-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021612-002	LIPOFEN	100MG	CAPSULE / ORAL		2006-01-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021612-003	LIPOFEN	150MG	CAPSULE / ORAL	RLD, RS	2006-01-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021612-001	LIPOFEN	50MG	CAPSULE / ORAL	RLD	2006-01-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021612-002	LIPOFEN	100MG	CAPSULE / ORAL		2006-01-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021612-003	LIPOFEN	150MG	CAPSULE / ORAL	RLD, RS	2006-01-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021612-001	LIPOFEN	50MG	CAPSULE / ORAL	RLD	2006-01-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021612-002	LIPOFEN	100MG	CAPSULE / ORAL		2006-01-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021612-003	LIPOFEN	150MG	CAPSULE / ORAL	RLD, RS	2006-01-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021612-001	LIPOFEN	50MG	CAPSULE / ORAL	RLD	2006-01-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021612-002	LIPOFEN	100MG	CAPSULE / ORAL		2006-01-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021612-003	LIPOFEN	150MG	CAPSULE / ORAL	RLD, RS	2006-01-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021612-001	LIPOFEN	50MG	CAPSULE / ORAL	RLD	2006-01-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021612-002	LIPOFEN	100MG	CAPSULE / ORAL		2006-01-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021612-003	LIPOFEN	150MG	CAPSULE / ORAL	RLD, RS	2006-01-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021612-001	LIPOFEN	50MG	CAPSULE / ORAL	RLD	2006-01-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021612-002	LIPOFEN	100MG	CAPSULE / ORAL		2006-01-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021612-003	LIPOFEN	150MG	CAPSULE / ORAL	RLD, RS	2006-01-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021612-001	LIPOFEN	50MG	CAPSULE / ORAL	RLD	2006-01-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021612-002	LIPOFEN	100MG	CAPSULE / ORAL		2006-01-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021612-003	LIPOFEN	150MG	CAPSULE / ORAL	RLD, RS	2006-01-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021612-001	LIPOFEN	50MG	CAPSULE / ORAL	RLD	2006-01-11	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61269-210-90	EA - Each	61269-210	f4c5516c-b59c-4069-8b27-ddd576fb5578	1	2014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FENOFIBRATE	ACTIVE INGREDIENT	U202363UOS	FENOFIBRATE CAPSULE [H2-PHARMA, LLC]	1
FENOFIBRATE	ACTIVE MOIETY	U202363UOS	FENOFIBRATE CAPSULE [H2-PHARMA, LLC]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	FENOFIBRATE CAPSULE [H2-PHARMA, LLC]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	FENOFIBRATE CAPSULE [H2-PHARMA, LLC]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	FENOFIBRATE CAPSULE [H2-PHARMA, LLC]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	FENOFIBRATE CAPSULE [H2-PHARMA, LLC]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	FENOFIBRATE CAPSULE [H2-PHARMA, LLC]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	FENOFIBRATE CAPSULE [H2-PHARMA, LLC]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	FENOFIBRATE CAPSULE [H2-PHARMA, LLC]	1
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	FENOFIBRATE CAPSULE [H2-PHARMA, LLC]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	FENOFIBRATE CAPSULE [H2-PHARMA, LLC]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	FENOFIBRATE CAPSULE [H2-PHARMA, LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FENOFIBRATE CAPSULE [H2-PHARMA, LLC]	1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lipofen	FENOFIBRATE	ANI Pharmaceuticals, Inc.	78b789b9-854f-46b9-97f3-a48759a6ff89	2026-05-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021612 application number: NDA021612
Fenofibrate	FENOFIBRATE	ANI Pharmaceuticals, Inc.	3a69e15a-eda6-4a6e-8934-6881e4370521	2026-05-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021612 application number: NDA021612

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fenofibrate	H2-Pharma, LLC \| Galephar Pharmaceutical Research Inc. \| Chemagis Ltd.	2014-05-01	HUMAN PRESCRIPTION DRUG LABEL	1