fenofibrate

Product NDC: 70518-2349
11-digit product format: 705182349
Labeler code: 70518
Product ID: 70518-2349_db74b4d0-f045-043c-e053-2995a90a7b28
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: fenofibrate
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA210138
Marketing category: ANDA
Marketing start: 2019-10-06
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: 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	70518-2349		D	Discontinued by firm		2026-08-03
excluded package	package	70518-2349	70518-2349-0	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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70518-2349-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70518-2349-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70518-2349-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70518-2349-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70518-2349-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70518-2349-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70518-2349-0	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70518-2349-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70518-2349-0	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70518-2349-0	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70518-2349-0	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70518-2349-0	`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
A210138-001	FENOFIBRATE	FENOFIBRATE	54MG	TABLET / ORAL	AB		2018-07-23
A210138-002	FENOFIBRATE	FENOFIBRATE	160MG	TABLET / ORAL	AB		2018-07-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210138-001	AB
A210138-002	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	A210138-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210138-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-07-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210138-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-07-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210138-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-07-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210138-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-07-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210138-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-07-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210138-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-07-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210138-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-07-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210138-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-07-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210138-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-07-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210138-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-07-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210138-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-07-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210138-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-07-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210138-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-07-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210138-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-07-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210138-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-07-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210138-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-07-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210138-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-07-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210138-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-07-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210138-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-07-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210138-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-07-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210138-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-07-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210138-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-07-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210138-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-07-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210138-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-07-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210138-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-07-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210138-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-07-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210138-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-07-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210138-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-07-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210138-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-07-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210138-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-07-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210138-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-07-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210138-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-07-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210138-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-07-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210138-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-07-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210138-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-07-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210138-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-07-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210138-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-07-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210138-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-07-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210138-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-07-23	`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	A210138-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210138-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210138-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210138-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210138-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210138-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210138-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210138-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210138-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210138-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210138-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210138-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210138-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210138-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210138-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210138-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210138-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210138-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210138-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210138-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210138-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210138-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210138-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210138-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210138-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210138-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210138-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210138-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210138-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210138-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210138-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210138-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210138-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210138-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210138-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210138-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210138-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210138-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210138-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210138-002	AB	1	`782e0a99824c…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70518-2349-0	2021-02-19	C162847	48780-1	ba0f9c33-291d-a910-e053-dadaa90a0b85	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
70518-2349-0	2021-01-29	C162847	48780-1	ba0f9c33-291d-a910-e053-dadaa90a0b85	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

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
fenofibrate	FENOFIBRATE	Bryant Ranch Prepack	42b1ad55-c449-4250-a666-bb36a6ff5b53	2026-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210138 application number: ANDA210138
fenofibrate	FENOFIBRATE	A-S Medication Solutions	58f0d475-24dc-4f93-aa40-3882b724b70f	2026-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210138 application number: ANDA210138
fenofibrate	FENOFIBRATE	Ajanta Pharma USA Inc.	eb400ea7-bbd8-440b-b8be-082121621408	2025-11-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210138 application number: ANDA210138
fenofibrate	FENOFIBRATE	Quality Care Products, LLC	d1fb3b66-cac9-49cd-a9f8-c4ce960f66e7	2024-12-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210138 application number: ANDA210138
fenofibrate	FENOFIBRATE	NuCare Pharmaceuticals,Inc.	8e9898d1-1fc0-b7c6-e053-2a95a90a65cd	2024-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210138 application number: ANDA210138
fenofibrate	FENOFIBRATE	Proficient Rx LP	b9a6866c-9dbe-4419-bcad-52ec0127821f	2022-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210138 application number: ANDA210138
fenofibrate	FENOFIBRATE	NCS HealthCare of KY, Inc dba Vangard Labs	fafbc0be-f0ba-4dcd-8aa5-89527bae5e84	2019-03-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210138 application number: ANDA210138

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
70518-2349-0	70518234900	90 TABLET in 1 BOTTLE, PLASTIC (70518-2349-0)	90 tablet	2019-10-06	0000-00-00	No	No	Current