Fenofibrate

Product NDC: 68788-7662
Requested package NDC: 68788-7662-1
11-digit product format: 687887662
Labeler code: 68788
Product ID: 68788-7662_79333850-4d27-457c-8057-016a0048ad19
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fenofibrate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Preferred Pharmaceuticals, Inc.
Application: ANDA209660
Marketing category: ANDA
Marketing start: 2020-02-28
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: 2022-12-31
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	68788-7662	68788-7662-1	D	Discontinued by firm		2026-08-03

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
A209660-001	FENOFIBRATE	FENOFIBRATE	54MG	TABLET / ORAL	AB		2019-02-11
A209660-002	FENOFIBRATE	FENOFIBRATE	160MG	TABLET / ORAL	AB		2019-02-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209660-001	AB
A209660-002	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	A209660-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2019-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209660-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2019-02-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209660-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2019-02-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209660-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2019-02-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209660-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2019-02-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209660-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2019-02-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209660-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2019-02-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209660-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2019-02-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209660-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2019-02-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209660-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2019-02-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209660-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2019-02-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209660-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2019-02-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209660-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2019-02-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209660-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2019-02-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209660-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2019-02-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209660-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2019-02-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209660-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2019-02-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209660-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2019-02-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209660-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2019-02-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209660-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2019-02-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209660-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2019-02-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209660-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2019-02-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209660-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2019-02-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209660-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2019-02-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209660-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2019-02-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209660-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2019-02-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209660-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2019-02-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209660-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2019-02-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209660-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2019-02-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209660-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2019-02-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209660-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2019-02-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209660-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2019-02-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209660-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2019-02-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209660-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2019-02-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209660-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2019-02-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209660-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2019-02-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209660-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2019-02-11	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209660-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2019-02-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209660-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2019-02-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209660-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2019-02-11	`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	A209660-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209660-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209660-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209660-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209660-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209660-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209660-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209660-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209660-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209660-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209660-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209660-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209660-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209660-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209660-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209660-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209660-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209660-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209660-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209660-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209660-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209660-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209660-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209660-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209660-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209660-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209660-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209660-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209660-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209660-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209660-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209660-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209660-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209660-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209660-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209660-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209660-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209660-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209660-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209660-002	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
68788-7662-1	EA - Each	68788-7662	76539385-8cb5-4c45-8e44-65f8b5863864	1	2020-05-08
68788-7662-3	EA - Each	68788-7662	9234fa0a-e5a3-4595-acfa-7658e7ba6b0a	1	2020-05-08
68788-7662-6	EA - Each	68788-7662	46eccb77-c573-4c4b-af88-5237210495ba	1	2020-05-08
68788-7662-9	EA - Each	68788-7662	c911e7c9-bae9-4272-847c-5d0a0e2a29da	1	2020-05-08

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fenofibrate	FENOFIBRATE	Chartwell RX, LLC	cc9d1672-5f82-45a1-b862-859703b3dc37	2024-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209660 application number: ANDA209660
Fenofibrate	FENOFIBRATE	Alembic Pharmaceuticals Limited	39e61e9d-dda8-4989-a3dd-79545a5c9157	2023-01-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209660 application number: ANDA209660
Fenofibrate	FENOFIBRATE	Alembic Pharmaceuticals Inc.	4387adac-eea0-40c5-8111-1b70e0d98d7e	2021-11-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209660 application number: ANDA209660
Fenofibrate	FENOFIBRATE	Alembic Pharmaceuticals Inc.	2985c70d-e85d-483e-8d36-7a4b8454b038	2021-11-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209660 application number: ANDA209660

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
68788-7662-1	68788766201	100 TABLET, FILM COATED in 1 BOTTLE (68788-7662-1)	2020-02-28	0000-00-00	No	No	Current