Fenofibrate

Product NDC: 16714-741
11-digit product format: 167140741
Labeler code: 16714
Product ID: 16714-741_502bc6e9-5f21-4a1e-866d-baa8a08b512e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: fenofibrate
Dosage form: CAPSULE
Route: ORAL
Labeler: Northstar Rx LLC
Application: ANDA207378
Marketing category: ANDA
Marketing start: 2017-08-21
Marketing end: 0000-00-00
Substance: FENOFIBRATE
Active strength: 200 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#

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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	16714-741		D	Discontinued by firm	2026-10-05
excluded package	package	16714-741	16714-741-01	D	Discontinued by firm	2026-10-05
excluded package	package	16714-741	16714-741-02	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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	16714-741-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	16714-741-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	16714-741-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	16714-741-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	16714-741-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	16714-741-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	16714-741-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	16714-741-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	16714-741-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	16714-741-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	16714-741-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	16714-741-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	16714-741-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	16714-741-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	16714-741-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	16714-741-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	16714-741-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	16714-741-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	16714-741-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	16714-741-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	16714-741-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	16714-741-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	16714-741-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	16714-741-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

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	Approval date
A207378-001	FENOFIBRATE (MICRONIZED)	FENOFIBRATE	67MG	CAPSULE / ORAL	2017-03-28
A207378-002	FENOFIBRATE (MICRONIZED)	FENOFIBRATE	134MG	CAPSULE / ORAL	2017-03-28
A207378-003	FENOFIBRATE (MICRONIZED)	FENOFIBRATE	200MG	CAPSULE / ORAL	2017-03-28

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A207378-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	2017-03-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207378-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	2017-03-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207378-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	2017-03-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207378-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	2017-03-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207378-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	2017-03-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207378-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	2017-03-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207378-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	2017-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207378-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	2017-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207378-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	2017-03-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207378-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	2017-03-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207378-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	2017-03-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207378-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	2017-03-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207378-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	2017-03-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207378-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	2017-03-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207378-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	2017-03-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207378-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	2017-03-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207378-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	2017-03-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207378-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	2017-03-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207378-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	2017-03-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207378-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	2017-03-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207378-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	2017-03-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207378-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	2017-03-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207378-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	2017-03-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207378-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	2017-03-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207378-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	2017-03-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207378-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	2017-03-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207378-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	2017-03-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207378-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	2017-03-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207378-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	2017-03-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207378-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	2017-03-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207378-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	2017-03-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207378-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	2017-03-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207378-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	2017-03-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207378-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	2017-03-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207378-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	2017-03-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207378-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	2017-03-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207378-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	2017-03-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207378-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	2017-03-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207378-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	2017-03-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207378-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	2017-03-28	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207378-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207378-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207378-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207378-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207378-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207378-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207378-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207378-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207378-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207378-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207378-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207378-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207378-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207378-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207378-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207378-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207378-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207378-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207378-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207378-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207378-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207378-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A207378-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A207378-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207378-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A207378-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A207378-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207378-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A207378-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A207378-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207378-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A207378-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A207378-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207378-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A207378-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A207378-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207378-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A207378-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A207378-003	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207378-001	AB	1	`6a51e52b5d6a…`

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
16714-741-02	EA - Each	16714-741	175eb401-3ea1-4848-97b0-5eb215eecd32	1	2017-09-11

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fenofibrate	FENOFIBRATE	Cipla USA Inc.,	07d47c02-ab29-4ba9-aea0-96ffbd70c0ef	2023-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207378 application number: ANDA207378

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
16714-741-01	16714074101	90 CAPSULE in 1 BOTTLE, PLASTIC (16714-741-01)	90 capsule	2017-08-21	0000-00-00	No	No	Current
16714-741-02	16714074102	100 CAPSULE in 1 BOTTLE, PLASTIC (16714-741-02)	100 capsule	2017-08-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fenofibrate - Northstar Rx LLC \| InvaGen Pharmaceuticals Inc.	Northstar Rx LLC \| InvaGen Pharmaceuticals Inc.	2021-11-23	HUMAN PRESCRIPTION DRUG LABEL	5