FENOFIBRATE

Product NDC: 42291-289
11-digit product format: 422910289
Labeler code: 42291
Product ID: 42291-289_e7b3cc50-62e2-2f0d-e053-2a95a90a76fc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: FENOFIBRATE
Dosage form: TABLET
Route: ORAL
Labeler: AvKARE
Application: ANDA076509
Marketing category: ANDA
Marketing start: 2015-04-01
Marketing end: 0000-00-00
Substance: FENOFIBRATE
Active strength: 54 mg/1
Pharmacologic classes: Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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	42291-289		D	Discontinued by firm		2026-08-10
excluded package	package	42291-289	42291-289-90	D	Discontinued by firm		2026-08-10

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 · 24 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	42291-289-90	`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	42291-289-90	`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	42291-289-90	`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	42291-289-90	`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	42291-289-90	`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	42291-289-90	`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	42291-289-90	`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	42291-289-90	`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	42291-289-90	`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	42291-289-90	`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	42291-289-90	`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	42291-289-90	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076509-001	FENOFIBRATE	FENOFIBRATE	54MG	TABLET / ORAL	AB		2008-03-26
A076509-002	FENOFIBRATE	FENOFIBRATE	160MG	TABLET / ORAL	AB	RS	2008-03-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A076509-001	AB
A076509-002	AB

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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076509-001	FENOFIBRATE	54MG	TABLET / ORAL	AB		2008-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076509-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	RS	2008-03-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076509-001	FENOFIBRATE	54MG	TABLET / ORAL	AB		2008-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076509-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	RS	2008-03-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076509-001	FENOFIBRATE	54MG	TABLET / ORAL	AB		2008-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076509-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	RS	2008-03-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076509-001	FENOFIBRATE	54MG	TABLET / ORAL	AB		2008-03-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076509-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	RS	2008-03-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076509-001	FENOFIBRATE	54MG	TABLET / ORAL	AB		2008-03-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076509-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	RS	2008-03-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076509-001	FENOFIBRATE	54MG	TABLET / ORAL	AB		2008-03-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076509-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	RS	2008-03-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076509-001	FENOFIBRATE	54MG	TABLET / ORAL	AB		2008-03-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076509-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	RS	2008-03-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076509-001	FENOFIBRATE	54MG	TABLET / ORAL	AB		2008-03-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076509-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	RS	2008-03-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076509-001	FENOFIBRATE	54MG	TABLET / ORAL	AB		2008-03-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076509-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	RS	2008-03-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076509-001	FENOFIBRATE	54MG	TABLET / ORAL	AB		2008-03-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076509-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	RS	2008-03-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076509-001	FENOFIBRATE	54MG	TABLET / ORAL	AB		2008-03-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076509-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	RS	2008-03-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076509-001	FENOFIBRATE	54MG	TABLET / ORAL	AB		2008-03-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076509-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	RS	2008-03-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076509-001	FENOFIBRATE	54MG	TABLET / ORAL	AB		2008-03-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076509-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	RS	2008-03-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076509-001	FENOFIBRATE	54MG	TABLET / ORAL	AB		2008-03-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076509-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	RS	2008-03-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076509-001	FENOFIBRATE	54MG	TABLET / ORAL	AB		2008-03-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076509-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	RS	2008-03-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076509-001	FENOFIBRATE	54MG	TABLET / ORAL	AB		2008-03-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076509-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	RS	2008-03-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076509-001	FENOFIBRATE	54MG	TABLET / ORAL	AB		2008-03-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076509-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	RS	2008-03-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076509-001	FENOFIBRATE	54MG	TABLET / ORAL	AB		2008-03-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076509-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	RS	2008-03-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076509-001	FENOFIBRATE	54MG	TABLET / ORAL	AB		2008-03-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076509-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	RS	2008-03-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076509-001	FENOFIBRATE	54MG	TABLET / ORAL	AB		2008-03-26	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076509-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	RS	2008-03-26	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076509-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076509-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076509-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076509-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076509-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076509-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076509-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076509-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076509-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076509-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076509-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076509-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076509-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076509-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076509-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076509-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076509-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076509-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076509-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076509-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076509-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076509-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076509-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076509-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076509-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076509-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076509-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076509-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076509-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076509-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076509-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076509-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076509-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076509-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076509-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076509-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076509-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076509-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076509-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076509-002	AB	1	`782e0a99824c…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42291-289-90	EA - Each	42291-289	0770036b-deec-4e47-9229-6e79f38cd1a4	1	2015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FENOFIBRATE	ACTIVE INGREDIENT	U202363UOS	FENOFIBRATE (FENOFIBRATE) TABLET [AVKARE, INC.]	2
FENOFIBRATE	ACTIVE MOIETY	U202363UOS	FENOFIBRATE (FENOFIBRATE) TABLET [AVKARE, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	FENOFIBRATE (FENOFIBRATE) TABLET [AVKARE, INC.]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	FENOFIBRATE (FENOFIBRATE) TABLET [AVKARE, INC.]	2
D&c Yellow No. 10	INACTIVE INGREDIENT	35SW5USQ3G	FENOFIBRATE (FENOFIBRATE) TABLET [AVKARE, INC.]	2
Fd&c Yellow No. 6	INACTIVE INGREDIENT	H77VEI93A8	FENOFIBRATE (FENOFIBRATE) TABLET [AVKARE, INC.]	2
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	FENOFIBRATE (FENOFIBRATE) TABLET [AVKARE, INC.]	2
HYPROMELLOSE 2910 (50 MPA.S)	INACTIVE INGREDIENT	1IVH67816N	FENOFIBRATE (FENOFIBRATE) TABLET [AVKARE, INC.]	2
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	FENOFIBRATE (FENOFIBRATE) TABLET [AVKARE, INC.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	FENOFIBRATE (FENOFIBRATE) TABLET [AVKARE, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FENOFIBRATE (FENOFIBRATE) TABLET [AVKARE, INC.]	2
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	FENOFIBRATE (FENOFIBRATE) TABLET [AVKARE, INC.]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	FENOFIBRATE (FENOFIBRATE) TABLET [AVKARE, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FENOFIBRATE (FENOFIBRATE) TABLET [AVKARE, INC.]	2
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	FENOFIBRATE (FENOFIBRATE) TABLET [AVKARE, INC.]	2

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FENOFIBRATE	FENOFIBRATE	Amneal Pharmaceuticals LLC	65f5dcad-5073-4347-9ec9-e7f350b134c4	2026-06-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076509 application number: ANDA076509
FENOFIBRATE	FENOFIBRATE	Northwind Health Company, LLC	4b4447a1-8136-4258-b2c8-c5f9c1bcec92	2025-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076509 application number: ANDA076509
FENOFIBRATE	FENOFIBRATE	AvPAK	d4e1d692-3c03-7406-ee06-7a6fb39ed3e7	2025-11-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076509 application number: ANDA076509
FENOFIBRATE	FENOFIBRATE	REMEDYREPACK INC.	882ee82a-3c56-4173-af42-68c3aadc8aa7	2025-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076509 application number: ANDA076509
FENOFIBRATE	FENOFIBRATE	PD-Rx Pharmaceuticals, Inc.	35ba17d9-0dd7-4f15-8f74-be5fd15f1917	2025-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076509 application number: ANDA076509
FENOFIBRATE	FENOFIBRATE	A-S Medication Solutions	3f2b3a16-7735-487e-9a2c-e078a18df1bc	2024-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076509 application number: ANDA076509
FENOFIBRATE	FENOFIBRATE	A-S Medication Solutions	f937a176-3d3e-4dc6-a7d4-c1a4749c7a7f	2023-12-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076509 application number: ANDA076509
FENOFIBRATE	FENOFIBRATE	Amneal Pharmaceuticals of New York LLC	fa08cf6a-d306-4979-9b23-ac7febf4fd12	2021-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076509 application number: ANDA076509

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
42291-289-90	42291028990	90 TABLET in 1 BOTTLE (42291-289-90)	90 tablet	2015-04-01	0000-00-00	No	No	Current