Fenofibrate

Product NDC: 43353-898
Requested package NDC: 43353-898-19
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	43353-898	43353-898-19	D	Discontinued by firm		2026-08-10

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 123 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
2026-02-19 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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076520-002	FENOFIBRATE	107MG	TABLET / ORAL		2005-12-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076520-003	FENOFIBRATE	160MG	TABLET / ORAL	AB	2007-10-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076520-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2007-10-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076520-002	FENOFIBRATE	107MG	TABLET / ORAL		2005-12-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076520-003	FENOFIBRATE	160MG	TABLET / ORAL	AB	2007-10-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076520-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2007-10-25	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 72 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076520-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076520-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076520-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076520-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076520-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076520-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076520-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076520-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076520-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076520-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076520-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076520-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076520-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076520-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076520-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076520-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076520-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076520-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076520-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076520-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076520-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076520-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076520-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076520-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076520-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076520-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076520-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076520-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076520-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076520-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076520-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076520-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076520-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076520-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076520-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A076520-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076520-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A076520-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076520-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A076520-003	AB	1	`c0c555d07b60…`

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