Fenofibrate

Product NDC: 42291-045
11-digit product format: 422910045
Labeler code: 42291
Product ID: 42291-045_484c0370-9350-0c79-e063-6394a90afce7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fenofibrate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: AvKARE
Application: ANDA204598
Marketing category: ANDA
Marketing start: 2024-01-04
Substance: FENOFIBRATE
Active strength: 145 mg/1
Pharmacologic classes: Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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
A204598-001	FENOFIBRATE	FENOFIBRATE	48MG	TABLET / ORAL	AB		2016-07-12
A204598-002	FENOFIBRATE	FENOFIBRATE	145MG	TABLET / ORAL	AB		2016-07-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204598-001	AB
A204598-002	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204598-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-07-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204598-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-07-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204598-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-07-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204598-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-07-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204598-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-07-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204598-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-07-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204598-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-07-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204598-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-07-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204598-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-07-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204598-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-07-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204598-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-07-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204598-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-07-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204598-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-07-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204598-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-07-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204598-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-07-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204598-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-07-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204598-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-07-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204598-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-07-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204598-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-07-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204598-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-07-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204598-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-07-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204598-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-07-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204598-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-07-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204598-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-07-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204598-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-07-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204598-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-07-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204598-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-07-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204598-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-07-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204598-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-07-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204598-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-07-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204598-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-07-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204598-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-07-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204598-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-07-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204598-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-07-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204598-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-07-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204598-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-07-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204598-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-07-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204598-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-07-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204598-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-07-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204598-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-07-12	`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	A204598-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204598-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204598-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204598-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204598-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204598-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204598-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204598-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204598-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204598-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204598-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204598-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204598-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204598-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204598-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204598-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204598-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204598-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204598-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204598-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204598-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204598-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204598-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204598-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204598-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204598-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204598-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204598-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204598-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204598-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204598-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204598-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204598-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204598-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204598-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204598-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204598-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204598-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204598-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204598-002	AB	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Fenofibrate
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FENOFIBRATE	145 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
U202363UOS	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
477560	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0e240290-f11b-8cc4-e063-6294a90a74f0	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
193bb7da-5c03-8f95-9048-23ef403846b0	Product name	3	20250616
fa35fb9a-7146-716b-13c8-bc1f60030232	Product name	9	20250114
cfc78bfa-7d55-47e5-aeb7-71cd79f5ca07	Product name	8	20231212
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
53d5b6b7-785a-4500-9460-263c7f8424b8	Product name	5	20210105
ed9d55d4-85bd-0ee7-5b4a-b705646a3a66	Product name	9	20200708
36a239c8-03fb-0083-81af-6c1afb195671	Product name	1	20140508
a0296d70-ca85-018c-84e8-cf3f630976b7	Product name	1	20140508
f2e3e9c8-a2f9-0cc3-a5a5-6dfd0279372a	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42291-045-90	Fenofibrate	90 in 1 BOTTLE	TABLET, FILM COATED	90		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42291-045-90	EA - Each	42291-045	af67a10f-3ddf-4838-a05d-c3ed86673b33	1	2024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42291-045	FENOFIBRATE TABLET, FILM COATED [AVKARE]	1	Current NDC, 1 package rows	20240105_0e240290-f11b-8cc4-e063-6294a90a74f0.zip

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fenofibrate	FENOFIBRATE	Preferred Pharmaceuticals, Inc.	c810b16b-32e2-4d0c-aa28-bf1f62110757	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204598 application number: ANDA204598
Fenofibrate	FENOFIBRATE	A-S Medication Solutions	d9c60b43-dc61-4976-b31f-09c8f8a33138	2026-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204598 application number: ANDA204598
Fenofibrate	FENOFIBRATE	AvKARE	0e240290-f11b-8cc4-e063-6294a90a74f0	2026-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204598 application number: ANDA204598 ndc (product): 42291-045
Fenofibrate	FENOFIBRATE	Bryant Ranch Prepack	f04cfe2a-1c06-4a7f-8149-7736a96e8f73	2025-10-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204598 application number: ANDA204598
Fenofibrate	FENOFIBRATE	Bryant Ranch Prepack	8eee54d1-48ca-4704-93f3-0ac6fd7f464e	2025-09-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204598 application number: ANDA204598
Fenofibrate	FENOFIBRATE	Camber Pharmaceuticals, Inc.	38f43148-4ca0-402a-ba39-8ee5011a7907	2025-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204598 application number: ANDA204598

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
477560	fenofibrate 145 MG Oral Tablet	PSN	0e240290-f11b-8cc4-e063-6294a90a74f0	2
477560	fenofibrate 145 MG Oral Tablet	SCD	0e240290-f11b-8cc4-e063-6294a90a74f0	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
42291-045-90	42291004590	90 TABLET, FILM COATED in 1 BOTTLE (42291-045-90)	2024-01-04	No	No	Current