Fenofibrate

Product NDC: 68788-7932
Requested package NDC: 68788-7932-3
11-digit product format: 687887932
Labeler code: 68788
Product ID: 68788-7932_da358160-8a43-4ce1-b0d9-dad1a141f459
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: fenofibrate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA202856
Marketing category: ANDA
Marketing start: 2021-06-15
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	68788-7932	68788-7932-3	D	Discontinued by firm		2026-08-03

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
A202856-001	FENOFIBRATE	FENOFIBRATE	48MG	TABLET / ORAL	AB		2012-12-07
A202856-002	FENOFIBRATE	FENOFIBRATE	145MG	TABLET / ORAL	AB		2012-12-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202856-001	AB
A202856-002	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	A202856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-12-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-12-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-12-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-12-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-12-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-12-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-12-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-12-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-12-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-12-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-12-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-12-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-12-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-12-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-12-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-12-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-12-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-12-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-12-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-12-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-12-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-12-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-12-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-12-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-12-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-12-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-12-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-12-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-12-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-12-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-12-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-12-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-12-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-12-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-12-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-12-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-12-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-12-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-12-07	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-12-07	`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	A202856-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202856-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202856-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202856-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202856-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202856-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202856-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202856-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202856-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202856-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202856-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202856-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202856-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202856-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202856-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202856-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202856-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202856-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202856-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202856-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202856-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202856-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202856-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202856-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202856-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202856-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202856-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202856-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202856-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202856-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202856-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202856-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202856-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202856-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202856-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202856-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202856-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202856-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202856-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202856-002	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
68788-7932-1	EA - Each	68788-7932	4185ebc7-e089-42fe-bd76-e7d3760c9899	1	2021-07-15
68788-7932-3	EA - Each	68788-7932	e4f4c0b2-17f7-4fc1-898e-81016d33cb61	1	2021-07-15
68788-7932-6	EA - Each	68788-7932	62cf0100-5d82-497c-8005-e19e401e395a	1	2021-07-15
68788-7932-9	EA - Each	68788-7932	d47092c6-4a93-4ccd-8879-72810013a06d	1	2021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-7932	FENOFIBRATE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]	5	Legacy NDC	20250511_ceedfb5d-8a04-4b4b-852f-1eac963f96a3.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	Safecor Health, LLC	9cc2038d-750e-42dc-b818-c5642cf6a5ad	2026-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202856 application number: ANDA202856
Fenofibrate	FENOFIBRATE	Mylan Pharmaceuticals Inc.	0f958942-1504-40a1-8ad8-43df2c3f717e	2025-08-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202856 application number: ANDA202856
Fenofibrate	FENOFIBRATE	Mylan Institutional Inc.	5a90e0a4-7892-462f-9776-037d23a93b10	2025-07-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202856 application number: ANDA202856
Fenofibrate	FENOFIBRATE	A-S Medication Solutions	43aa7e51-443c-4ea0-abf2-f7d9378b3ba9	2024-10-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202856 application number: ANDA202856
Fenofibrate	FENOFIBRATE	A-S Medication Solutions	dd98e467-ecb3-463c-81d8-8b4d89159ab0	2024-02-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202856 application number: ANDA202856
Fenofibrate	FENOFIBRATE	Bryant Ranch Prepack	42b1daf6-1f0e-4464-b160-7c10c492a570	2023-11-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202856 application number: ANDA202856

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
68788-7932-3	68788793203	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-7932-3)	2021-06-15	0000-00-00	No	No	Current