Fenofibrate

Product NDC: 42858-660
11-digit product format: 428580660
Labeler code: 42858
Product ID: 42858-660_2ee176e8-44de-4206-a71a-d0cbacdc0a81
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fenofibrate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Rhodes Pharmaceuticals L.P.
Application: ANDA076433
Marketing category: ANDA
Marketing start: 2017-06-01
Substance: FENOFIBRATE
Active strength: 160 mg/1
Pharmacologic classes: Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
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
A076433-001	FENOFIBRATE	FENOFIBRATE	54MG	TABLET / ORAL	AB		2005-05-13
A076433-002	FENOFIBRATE	FENOFIBRATE	160MG	TABLET / ORAL	AB		2005-05-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076433-001	AB
A076433-002	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	A076433-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2005-05-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076433-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2005-05-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076433-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2005-05-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076433-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2005-05-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076433-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2005-05-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076433-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2005-05-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076433-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2005-05-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076433-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2005-05-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076433-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2005-05-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076433-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2005-05-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076433-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2005-05-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076433-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2005-05-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076433-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2005-05-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076433-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2005-05-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076433-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2005-05-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076433-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2005-05-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076433-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2005-05-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076433-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2005-05-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076433-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2005-05-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076433-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2005-05-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076433-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2005-05-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076433-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2005-05-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076433-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2005-05-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076433-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2005-05-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076433-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2005-05-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076433-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2005-05-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076433-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2005-05-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076433-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2005-05-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076433-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2005-05-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076433-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2005-05-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076433-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2005-05-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076433-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2005-05-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076433-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2005-05-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076433-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2005-05-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076433-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2005-05-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076433-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2005-05-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076433-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2005-05-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076433-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2005-05-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076433-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2005-05-13	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076433-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2005-05-13	`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	A076433-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076433-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076433-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076433-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076433-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076433-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076433-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076433-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076433-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076433-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076433-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076433-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076433-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076433-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076433-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076433-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076433-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076433-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076433-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076433-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076433-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076433-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076433-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076433-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076433-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076433-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076433-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076433-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076433-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076433-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076433-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076433-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076433-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076433-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076433-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076433-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076433-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076433-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076433-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076433-002	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	160 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
349287	Internal RxNorm lookup
351133	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
5e7b79ab-9df0-4bbf-b7a4-a44aec203555	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
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
42858-660-45	Fenofibrate	90 in 1 BOTTLE	TABLET, FILM COATED	90		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42858-660-45	EA - Each	42858-660	00382d25-f169-4acb-b88d-c0960cee8572	1	2017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42858-660	FENOFIBRATE TABLET, FILM COATED [RHODES PHARMACEUTICALS L.P.]	8	Current NDC, Legacy NDC, 1 package rows	20230309_5e7b79ab-9df0-4bbf-b7a4-a44aec203555.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fenofibrate	FENOFIBRATE	Golden State Medical Supply, Inc.	6dd2e25c-aded-4499-e053-2991aa0a9d60	2026-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076433 application number: ANDA076433
Fenofibrate	FENOFIBRATE	Rhodes Pharmaceuticals LLC	5e7b79ab-9df0-4bbf-b7a4-a44aec203555	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076433 application number: ANDA076433 ndc (product): 42858-660
Fenofibrate	FENOFIBRATE	Bryant Ranch Prepack	40ca5d88-6403-4c4b-ae7f-ae8cec4d9965	2025-09-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076433 application number: ANDA076433
Fenofibrate	FENOFIBRATE	American Health Packaging	66761695-8630-49ff-8264-965dee246437	2025-04-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076433 application number: ANDA076433
Fenofibrate	FENOFIBRATE	Bryant Ranch Prepack	67a0cee0-79be-472a-a2a3-3aee2410b58b	2024-01-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076433 application number: ANDA076433

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
349287	fenofibrate 160 MG Oral Tablet	PSN	67a0cee0-79be-472a-a2a3-3aee2410b58b	101
349287	fenofibrate 160 MG Oral Tablet	SCD	67a0cee0-79be-472a-a2a3-3aee2410b58b	101
349287	fenofibrate 160 MG Oral Tablet	PSN	6dd2e25c-aded-4499-e053-2991aa0a9d60	10
351133	fenofibrate 54 MG Oral Tablet	PSN	6dd2e25c-aded-4499-e053-2991aa0a9d60	10
349287	fenofibrate 160 MG Oral Tablet	SCD	6dd2e25c-aded-4499-e053-2991aa0a9d60	10
351133	fenofibrate 54 MG Oral Tablet	SCD	6dd2e25c-aded-4499-e053-2991aa0a9d60	10
349287	fenofibrate 160 MG Oral Tablet	PSN	40ca5d88-6403-4c4b-ae7f-ae8cec4d9965	8
349287	fenofibrate 160 MG Oral Tablet	SCD	40ca5d88-6403-4c4b-ae7f-ae8cec4d9965	8
349287	fenofibrate 160 MG Oral Tablet	PSN	4edae668-9606-475e-9e99-455491999065	5
349287	fenofibrate 160 MG Oral Tablet	SCD	4edae668-9606-475e-9e99-455491999065	5
349287	fenofibrate 160 MG Oral Tablet	PSN	66761695-8630-49ff-8264-965dee246437	1
351133	fenofibrate 54 MG Oral Tablet	PSN	66761695-8630-49ff-8264-965dee246437	1
349287	fenofibrate 160 MG Oral Tablet	SCD	66761695-8630-49ff-8264-965dee246437	1
351133	fenofibrate 54 MG Oral Tablet	SCD	66761695-8630-49ff-8264-965dee246437	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
42858-660-45	42858066045	90 TABLET, FILM COATED in 1 BOTTLE (42858-660-45)	2017-06-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fenofibrate	Golden State Medical Supply, Inc.	2026-06-16	HUMAN PRESCRIPTION DRUG LABEL	11
Fenofibrate	Rhodes Pharmaceuticals LLC \| Frontida BioPharm Inc. \| Adare Pharmaceuticals, Inc.	2026-06-01	HUMAN PRESCRIPTION DRUG LABEL	10
Fenofibrate	Bryant Ranch Prepack	2025-09-17	HUMAN PRESCRIPTION DRUG LABEL	8
Fenofibrate	American Health Packaging	2025-04-19	HUMAN PRESCRIPTION DRUG LABEL	1
Fenofibrate	Bryant Ranch Prepack	2024-01-12	HUMAN PRESCRIPTION DRUG LABEL	101
Fenofibrate	A-S Medication Solutions	2021-04-16	HUMAN PRESCRIPTION DRUG LABEL	5
Fenofibrate	NuCare Pharmaceuticals,Inc.	2021-02-16	HUMAN PRESCRIPTION DRUG LABEL	3
Fenofibrate	NuCare Pharmaceuticals,Inc.	2021-02-16	HUMAN PRESCRIPTION DRUG LABEL	3
Fenofibrate	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2020-12-30	HUMAN PRESCRIPTION DRUG LABEL	2
Fenofibrate	St Mary's Medical Park Pharmacy \| St Mary's Medical Pak Pharmacy	2020-12-28	HUMAN PRESCRIPTION DRUG LABEL	2
Fenofibrate	Preferred Pharmaceuticals Inc.	2020-05-20	HUMAN PRESCRIPTION DRUG LABEL	2