Fenofibrate

Product NDC: 50090-5158
Requested package NDC: 50090-5158-1
11-digit product format: 500905158
Labeler code: 50090
Product ID: 50090-5158_7c06c7be-a7ba-49ae-a170-62ba5a92c344
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: FENOFIBRATE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA210670
Marketing category: ANDA
Marketing start: 2020-01-31
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	50090-5158	50090-5158-1	D	Discontinued by firm		2026-08-17

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 42.

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
A210670-001	FENOFIBRATE	FENOFIBRATE	54MG	TABLET / ORAL	AB		2019-09-06
A210670-002	FENOFIBRATE	FENOFIBRATE	160MG	TABLET / ORAL	AB		2019-09-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210670-001	AB
A210670-002	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
2026-08-18 06:07:40	2026-07	A210670-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2019-09-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210670-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2019-09-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210670-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2019-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210670-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2019-09-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210670-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2019-09-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210670-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2019-09-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210670-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2019-09-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210670-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2019-09-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210670-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2019-09-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210670-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2019-09-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210670-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2019-09-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210670-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2019-09-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210670-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2019-09-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210670-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2019-09-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210670-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2019-09-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210670-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2019-09-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210670-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2019-09-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210670-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2019-09-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210670-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2019-09-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210670-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2019-09-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210670-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2019-09-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210670-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2019-09-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210670-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2019-09-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210670-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2019-09-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210670-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2019-09-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210670-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2019-09-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210670-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2019-09-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210670-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2019-09-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210670-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2019-09-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210670-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2019-09-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210670-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2019-09-06	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210670-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2019-09-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210670-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2019-09-06	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210670-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2019-09-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210670-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2019-09-06	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210670-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2019-09-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210670-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2019-09-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210670-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2019-09-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210670-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2019-09-06	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210670-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2019-09-06	`bb7c543d1eb4…`

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
2026-08-18 06:07:40	2026-07	A210670-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210670-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210670-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210670-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210670-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210670-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210670-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210670-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210670-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210670-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210670-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210670-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210670-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210670-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210670-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210670-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210670-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210670-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210670-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210670-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210670-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210670-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210670-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210670-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210670-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210670-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210670-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210670-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210670-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210670-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210670-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210670-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210670-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210670-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210670-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210670-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210670-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210670-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210670-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210670-002	AB	1	`bb7c543d1eb4…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-5158-1	2023-02-06	C162847	48780-1	f386c649-f528-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use FENOFIBRATE TABLETS safely and effectively. See full prescribing information for FENOFIBRATE TABLETS. FENOFIBRATE tablets, for oral use Initial U.S. Approval: 1993
50090-5158-1	2023-01-30	C162847	48780-1	f386c649-f528-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use FENOFIBRATE TABLETS safely and effectively. See full prescribing information for FENOFIBRATE TABLETS. FENOFIBRATE tablets, for oral use Initial U.S. Approval: 1993

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-5158-1	EA - Each	50090-5158	200276e7-a9e8-4589-b8c0-e9692454f3e5	1	2021-08-05

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fenofibrate	FENOFIBRATE	Bryant Ranch Prepack	f3af845c-ce4e-4bf2-82e7-7753c9088645	2023-12-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210670 application number: ANDA210670
Fenofibrate	FENOFIBRATE	Dr. Reddy's Laboratories Inc.	9e69d844-5ded-46b6-8321-c420e8b37a63	2021-03-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210670 application number: ANDA210670

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
50090-5158-1	50090515801	90 TABLET, FILM COATED in 1 BOTTLE (50090-5158-1)	2020-09-21	0000-00-00	No	No	Current