Fenofibrate

Product NDC: 43353-898
11-digit product format: 433530898
Labeler code: 43353
Product ID: 43353-898_cd1cd9aa-0533-401b-b257-7f3a814c7ff7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: fenofibrate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA076520
Marketing category: ANDA
Marketing start: 2009-12-22
Marketing end: 0000-00-00
Substance: FENOFIBRATE
Active strength: 160 mg/1
Pharmacologic classes: Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2020-12-31
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	43353-898		D	Discontinued by firm		2026-10-12
excluded package	package	43353-898	43353-898-19	D	Discontinued by firm		2026-10-12

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
A076520-001	FENOFIBRATE	FENOFIBRATE	54MG	TABLET / ORAL	2007-10-25
A076520-002	FENOFIBRATE	FENOFIBRATE	107MG	TABLET / ORAL	2005-12-29
A076520-003	FENOFIBRATE	FENOFIBRATE	160MG	TABLET / ORAL	2007-10-25

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	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A076520-001	FENOFIBRATE	54MG	TABLET / ORAL		2007-10-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076520-002	FENOFIBRATE	107MG	TABLET / ORAL		2005-12-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076520-003	FENOFIBRATE	160MG	TABLET / ORAL		2007-10-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076520-001	FENOFIBRATE	54MG	TABLET / ORAL		2007-10-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076520-002	FENOFIBRATE	107MG	TABLET / ORAL		2005-12-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076520-003	FENOFIBRATE	160MG	TABLET / ORAL		2007-10-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076520-001	FENOFIBRATE	54MG	TABLET / ORAL		2007-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076520-002	FENOFIBRATE	107MG	TABLET / ORAL		2005-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076520-003	FENOFIBRATE	160MG	TABLET / ORAL		2007-10-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076520-001	FENOFIBRATE	54MG	TABLET / ORAL		2007-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076520-002	FENOFIBRATE	107MG	TABLET / ORAL		2005-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076520-003	FENOFIBRATE	160MG	TABLET / ORAL		2007-10-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076520-001	FENOFIBRATE	54MG	TABLET / ORAL		2007-10-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076520-002	FENOFIBRATE	107MG	TABLET / ORAL		2005-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076520-003	FENOFIBRATE	160MG	TABLET / ORAL		2007-10-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076520-001	FENOFIBRATE	54MG	TABLET / ORAL		2007-10-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076520-002	FENOFIBRATE	107MG	TABLET / ORAL		2005-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076520-003	FENOFIBRATE	160MG	TABLET / ORAL		2007-10-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076520-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2007-10-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076520-002	FENOFIBRATE	107MG	TABLET / ORAL		2005-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076520-003	FENOFIBRATE	160MG	TABLET / ORAL	AB	2007-10-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076520-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2007-10-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076520-002	FENOFIBRATE	107MG	TABLET / ORAL		2005-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076520-003	FENOFIBRATE	160MG	TABLET / ORAL	AB	2007-10-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076520-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2007-10-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076520-002	FENOFIBRATE	107MG	TABLET / ORAL		2005-12-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076520-003	FENOFIBRATE	160MG	TABLET / ORAL	AB	2007-10-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076520-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2007-10-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076520-002	FENOFIBRATE	107MG	TABLET / ORAL		2005-12-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076520-003	FENOFIBRATE	160MG	TABLET / ORAL	AB	2007-10-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076520-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2007-10-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076520-002	FENOFIBRATE	107MG	TABLET / ORAL		2005-12-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076520-003	FENOFIBRATE	160MG	TABLET / ORAL	AB	2007-10-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076520-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2007-10-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076520-002	FENOFIBRATE	107MG	TABLET / ORAL		2005-12-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076520-003	FENOFIBRATE	160MG	TABLET / ORAL	AB	2007-10-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076520-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2007-10-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076520-002	FENOFIBRATE	107MG	TABLET / ORAL		2005-12-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076520-003	FENOFIBRATE	160MG	TABLET / ORAL	AB	2007-10-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076520-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2007-10-25	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 72 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-14 00:12 UTC	2019-12	A076520-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076520-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076520-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076520-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076520-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076520-003	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076520-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076520-003	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076520-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A076520-003	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076520-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A076520-003	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076520-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076520-003	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076520-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076520-003	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076520-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076520-003	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076520-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076520-003	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076520-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A076520-003	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076520-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A076520-003	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076520-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076520-003	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076520-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A076520-003	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076520-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A076520-003	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076520-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076520-003	AB	1	`cb3db0bc1861…`

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
43353-898-19	EA - Each	43353-898	e6105e7e-8e46-4d1a-b56c-0d069cac4400	1	2018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43353-898	FENOFIBRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1	Legacy NDC	20171219_2e6e800b-23a6-4032-88c3-d29beb2d35fc.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	Marketing start	Marketing end	Sample	Exclude flag	Status
43353-898-19	43353089819	3060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-898-19)	2014-03-06	0000-00-00	No	No	Current