Fenofibrate

Product NDC: 51407-090
11-digit product format: 514070090
Labeler code: 51407
Product ID: 51407-090_c55e9d1d-d4fa-8d21-e053-2a95a90a0226
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fenofibrate
Dosage form: CAPSULE
Route: ORAL
Labeler: Golden State Medical Supply, Inc.
Application: ANDA075753
Marketing category: ANDA
Marketing start: 2002-09-03
Marketing end: 0000-00-00
Substance: FENOFIBRATE
Active strength: 67 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	51407-090		D	Discontinued by firm		2026-10-15
excluded package	package	51407-090	51407-090-90	D	Discontinued by firm		2026-10-15

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A075753-001	FENOFIBRATE (MICRONIZED)	FENOFIBRATE	67MG	CAPSULE / ORAL	2002-09-03
A075753-002	FENOFIBRATE (MICRONIZED)	FENOFIBRATE	134MG	CAPSULE / ORAL	2002-04-09
A075753-003	FENOFIBRATE (MICRONIZED)	FENOFIBRATE	200MG	CAPSULE / ORAL	2002-04-09

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 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A075753-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL		2002-09-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A075753-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL		2002-04-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A075753-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL		2002-04-09	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A075753-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL		2002-09-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075753-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL		2002-04-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075753-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL		2002-04-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075753-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2002-09-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075753-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2002-04-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075753-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2002-04-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075753-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2002-09-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075753-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2002-04-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075753-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2002-04-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075753-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2002-09-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075753-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2002-04-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075753-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2002-04-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075753-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2002-09-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075753-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2002-04-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075753-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2002-04-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075753-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2002-09-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075753-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2002-04-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075753-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2002-04-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075753-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2002-09-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075753-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2002-04-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075753-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2002-04-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075753-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2002-09-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075753-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2002-04-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075753-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2002-04-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075753-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2002-09-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075753-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2002-04-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075753-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2002-04-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075753-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2002-09-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075753-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2002-04-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075753-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2002-04-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075753-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2002-09-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075753-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2002-04-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075753-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2002-04-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075753-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2002-09-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075753-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2002-04-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075753-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2002-04-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075753-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2002-09-03	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075753-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075753-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075753-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075753-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075753-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075753-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075753-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075753-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075753-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075753-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075753-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075753-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075753-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075753-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075753-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075753-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075753-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075753-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075753-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075753-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075753-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075753-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075753-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075753-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075753-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075753-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075753-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A075753-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A075753-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075753-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A075753-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A075753-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075753-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A075753-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A075753-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075753-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075753-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075753-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075753-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075753-002	AB	1	`b00525d2431f…`

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
51407-090-90	EA - Each	51407-090	557a3726-3a7e-4c10-8fd3-174929dba0f2	1	2018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51407-090	FENOFIBRATE CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]	8	Legacy NDC	20230420_6e79dd5a-7f8e-53a9-e053-2991aa0a1ecd.zip

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
51407-090-90	51407009090	90 CAPSULE in 1 BOTTLE (51407-090-90)	90 capsule	2018-06-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
FENOFIBRATE CAPSULES, USP	Golden State Medical Supply, Inc.	2025-11-24	HUMAN PRESCRIPTION DRUG LABEL	9