FENOFIBRATE

Product NDC: 68788-7579
Requested package NDC: 68788-7579-6
11-digit product format: 687887579
Labeler code: 68788
Product ID: 68788-7579_0bf55df0-e94b-4a55-aaad-a5c2b3585bd2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: FENOFIBRATE
Dosage form: TABLET
Route: ORAL
Labeler: Preferred Pharmaceuticals, Inc.
Application: ANDA208709
Marketing category: ANDA
Marketing start: 2016-12-15
Marketing end: 0000-00-00
Substance: FENOFIBRATE
Active strength: 145 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68788-7579	68788-7579-6	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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`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
A208709-001	FENOFIBRATE	FENOFIBRATE	48MG	TABLET / ORAL	AB		2016-12-15
A208709-002	FENOFIBRATE	FENOFIBRATE	145MG	TABLET / ORAL	AB		2016-12-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208709-001	AB
A208709-002	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	A208709-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208709-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-12-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208709-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-12-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208709-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-12-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208709-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-12-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208709-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-12-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208709-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-12-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208709-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-12-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208709-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-12-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208709-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-12-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208709-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-12-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208709-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-12-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208709-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-12-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208709-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-12-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208709-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-12-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208709-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-12-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208709-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-12-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208709-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-12-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208709-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-12-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208709-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-12-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208709-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-12-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208709-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-12-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208709-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-12-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208709-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-12-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208709-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-12-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208709-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-12-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208709-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-12-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208709-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-12-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208709-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-12-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208709-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-12-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208709-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-12-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208709-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-12-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208709-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-12-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208709-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-12-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208709-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-12-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208709-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-12-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208709-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-12-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208709-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-12-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208709-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-12-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A208709-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-12-15	`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	A208709-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208709-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208709-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208709-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208709-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208709-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208709-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208709-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208709-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208709-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208709-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208709-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208709-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208709-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208709-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208709-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208709-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208709-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208709-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208709-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208709-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208709-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208709-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208709-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208709-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208709-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208709-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208709-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208709-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208709-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208709-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208709-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208709-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208709-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208709-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208709-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208709-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208709-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208709-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A208709-002	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
68788-7579-1	EA - Each	68788-7579	b1613029-f2bf-4016-aa6e-221dca6888ac	1	2020-09-14
68788-7579-3	EA - Each	68788-7579	bd982591-45ef-44b4-8c6d-212f489fc1b9	1	2020-09-14
68788-7579-6	EA - Each	68788-7579	8b185f7a-dca4-4123-b35d-399e8907da1d	1	2020-09-14
68788-7579-9	EA - Each	68788-7579	2e87440c-937e-41c3-95cb-155a659ce043	1	2020-09-14

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	Bryant Ranch Prepack	b11f1c74-23da-4273-b504-0a2ca22c4b5a	2026-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208709 application number: ANDA208709
FENOFIBRATE	FENOFIBRATE	Major Pharmaceuticals	bbffd586-f63a-4a84-bdfb-3e4a1df6449e	2026-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208709 application number: ANDA208709
Fenofibrate	FENOFIBRATE	Northwind Health Company, LLC	0178ea2e-2c79-b97b-e063-6394a90ac145	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208709 application number: ANDA208709
Fenofibrate	FENOFIBRATE	Northwind Health Company, LLC	f2b6e2a7-68d7-264d-e053-2a95a90aa9d1	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208709 application number: ANDA208709
Fenofibrate	FENOFIBRATE	Cipla USA Inc.	f8f09ab1-74db-4123-b85a-6337dc2582a0	2025-10-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208709 application number: ANDA208709
FENOFIBRATE	FENOFIBRATE	NCS HealthCare of KY, LLC dba Vangard Labs	4d8a93cb-6d66-4251-bb33-37982525ac09	2024-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208709 application number: ANDA208709
FENOFIBRATE	FENOFIBRATE	NuCare Pharmaceuticals,Inc.	968e7f57-1360-ba5a-e053-2995a90a206c	2024-06-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208709 application number: ANDA208709
FENOFIBRATE	FENOFIBRATE	A-S Medication Solutions	734f72a2-96f7-4480-9a87-c1ffd94b5f0b	2023-07-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208709 application number: ANDA208709

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
68788-7579-6	68788757906	60 TABLET in 1 BOTTLE (68788-7579-6)	60 tablet	2019-12-27	0000-00-00	No	No	Current