Fenofibrate

Product NDC: 68084-635
Requested package NDC: 68084-635-21
11-digit product format: 680840635
Labeler code: 68084
Product ID: 68084-635_c8e521b0-89a1-4445-e053-2995a90ad869
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fenofibrate
Dosage form: TABLET
Route: ORAL
Labeler: American Health Packaging
Application: ANDA090856
Marketing category: ANDA
Marketing start: 2013-01-17
Marketing end: 2022-06-30
Substance: FENOFIBRATE
Active strength: 48 mg/1
Pharmacologic classes: Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag: No
Listing certified through: 0000-00-00
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	68084-635	68084-635-21	D	Discontinued by firm		2026-08-11

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
A090856-001	FENOFIBRATE	FENOFIBRATE	48MG	TABLET / ORAL	AB		2011-12-23
A090856-002	FENOFIBRATE	FENOFIBRATE	145MG	TABLET / ORAL	AB		2011-12-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090856-001	AB
A090856-002	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	A090856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2011-12-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2011-12-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2011-12-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2011-12-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2011-12-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2011-12-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2011-12-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2011-12-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2011-12-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2011-12-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2011-12-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2011-12-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2011-12-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2011-12-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2011-12-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2011-12-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2011-12-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2011-12-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2011-12-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2011-12-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2011-12-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2011-12-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2011-12-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2011-12-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2011-12-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2011-12-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2011-12-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2011-12-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2011-12-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2011-12-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2011-12-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2011-12-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2011-12-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2011-12-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2011-12-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2011-12-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2011-12-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2011-12-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2011-12-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2011-12-23	`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	A090856-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090856-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090856-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090856-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090856-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090856-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090856-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090856-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090856-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090856-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090856-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090856-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090856-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090856-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090856-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090856-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090856-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090856-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090856-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090856-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090856-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090856-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090856-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090856-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090856-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090856-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090856-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090856-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090856-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090856-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090856-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090856-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090856-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090856-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090856-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090856-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090856-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090856-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090856-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090856-002	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
68084-635-11	EA - Each	68084-635	4352b502-3c05-44f4-8595-96b631c28050	1	2013-03-03
68084-635-21	EA - Each	68084-635	ecdaf563-4285-45f5-9b84-cbbfb24ed63a	1	2013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FENOFIBRATE	ACTIVE INGREDIENT	U202363UOS	FENOFIBRATE TABLET [AMERICAN HEALTH PACKAGING]	3
FENOFIBRATE	ACTIVE MOIETY	U202363UOS	FENOFIBRATE TABLET [AMERICAN HEALTH PACKAGING]	3
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	FENOFIBRATE TABLET [AMERICAN HEALTH PACKAGING]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	FENOFIBRATE TABLET [AMERICAN HEALTH PACKAGING]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	FENOFIBRATE TABLET [AMERICAN HEALTH PACKAGING]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	FENOFIBRATE TABLET [AMERICAN HEALTH PACKAGING]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FENOFIBRATE TABLET [AMERICAN HEALTH PACKAGING]	3
POLACRILIN POTASSIUM	INACTIVE INGREDIENT	0BZ5A00FQU	FENOFIBRATE TABLET [AMERICAN HEALTH PACKAGING]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	FENOFIBRATE TABLET [AMERICAN HEALTH PACKAGING]	3
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	FENOFIBRATE TABLET [AMERICAN HEALTH PACKAGING]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	FENOFIBRATE TABLET [AMERICAN HEALTH PACKAGING]	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	FENOFIBRATE TABLET [AMERICAN HEALTH PACKAGING]	3
SUCROSE	INACTIVE INGREDIENT	C151H8M554	FENOFIBRATE TABLET [AMERICAN HEALTH PACKAGING]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	FENOFIBRATE TABLET [AMERICAN HEALTH PACKAGING]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FENOFIBRATE TABLET [AMERICAN HEALTH PACKAGING]	3

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	Major Pharmaceuticals	d9be3ae3-6da9-47fd-bcfd-e561b9d585ca	2026-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090856 application number: ANDA090856
Fenofibrate	FENOFIBRATE	AvPAK	e949c068-bc7d-3038-e053-2a95a90aee00	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090856 application number: ANDA090856
Fenofibrate	FENOFIBRATE	Northwind Health Company, LLC	0865c177-b78a-318e-e063-6394a90a318a	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090856 application number: ANDA090856
Fenofibrate	FENOFIBRATE	Lupin Pharmaceuticals, Inc.	45364845-c3b4-40a1-a677-82202ffaa5ad	2025-11-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090856 application number: ANDA090856
Fenofibrate	FENOFIBRATE	American Health Packaging	d1f64796-6ba0-415c-a6a0-5456b21a7ed6	2025-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090856 application number: ANDA090856
Fenofibrate	FENOFIBRATE	Preferred Pharmaceuticals Inc.	2e6711e9-782d-46bd-9447-6612fe7d0fe7	2025-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090856 application number: ANDA090856

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
68084-635-21	68084063521	30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-635-21) > 1 TABLET in 1 BLISTER PACK (68084-635-11)	30 blister pack	2013-01-17	2022-06-30	No	No	Current