Fenofibrate

Product NDC: 70934-224
Requested package NDC: 70934-224-30
11-digit product format: 709340224
Labeler code: 70934
Product ID: 70934-224_b8ca78b7-116d-b2f4-e053-2a95a90ae00c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: fenofibrate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application: ANDA200884
Marketing category: ANDA
Marketing start: 2019-01-08
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: 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	70934-224	70934-224-30	I	Inactivated by FDA		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 · 15 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…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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
A200884-001	FENOFIBRATE	FENOFIBRATE	48MG	TABLET / ORAL			2017-09-07
A200884-002	FENOFIBRATE	FENOFIBRATE	145MG	TABLET / ORAL			2017-09-07

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	A200884-001	FENOFIBRATE	48MG	TABLET / ORAL		2017-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200884-002	FENOFIBRATE	145MG	TABLET / ORAL		2017-09-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200884-001	FENOFIBRATE	48MG	TABLET / ORAL		2017-09-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200884-002	FENOFIBRATE	145MG	TABLET / ORAL		2017-09-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200884-001	FENOFIBRATE	48MG	TABLET / ORAL		2017-09-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200884-002	FENOFIBRATE	145MG	TABLET / ORAL		2017-09-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200884-001	FENOFIBRATE	48MG	TABLET / ORAL		2017-09-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200884-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2017-09-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200884-001	FENOFIBRATE	48MG	TABLET / ORAL		2017-09-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200884-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2017-09-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200884-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2017-09-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200884-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2017-09-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200884-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2017-09-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200884-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2017-09-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200884-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2017-09-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200884-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2017-09-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200884-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2017-09-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200884-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2017-09-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200884-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2017-09-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200884-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2017-09-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200884-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2017-09-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200884-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2017-09-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200884-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2017-09-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200884-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2017-09-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200884-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2017-09-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200884-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2017-09-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200884-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2017-09-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200884-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2017-09-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200884-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2017-09-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200884-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2017-09-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200884-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2017-09-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200884-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2017-09-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200884-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2017-09-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200884-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2017-09-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200884-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2017-09-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200884-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2017-09-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200884-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2017-09-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A200884-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2017-09-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200884-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2017-09-07	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A200884-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2017-09-07	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 72 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200884-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200884-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200884-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200884-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200884-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200884-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200884-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200884-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200884-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200884-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200884-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200884-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200884-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200884-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200884-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200884-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200884-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200884-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200884-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200884-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200884-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200884-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200884-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200884-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200884-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200884-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200884-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200884-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200884-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A200884-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200884-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A200884-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200884-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200884-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200884-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A200884-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200884-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A200884-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200884-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A200884-002	AB	1	`c0c555d07b60…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
193bb7da-5c03-8f95-9048-23ef403846b0	Product name	3	20250616
fa35fb9a-7146-716b-13c8-bc1f60030232	Product name	9	20250114
cfc78bfa-7d55-47e5-aeb7-71cd79f5ca07	Product name	8	20231212
53d5b6b7-785a-4500-9460-263c7f8424b8	Product name	5	20210105
ed9d55d4-85bd-0ee7-5b4a-b705646a3a66	Product name	9	20200708
36a239c8-03fb-0083-81af-6c1afb195671	Product name	1	20140508
a0296d70-ca85-018c-84e8-cf3f630976b7	Product name	1	20140508
f2e3e9c8-a2f9-0cc3-a5a5-6dfd0279372a	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70934-224-30	2023-01-30	C162847	48780-1	ba0f9c33-3117-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 tablet, for oral use Initial U.S. Approval: 1993
70934-224-30	2021-01-31	C162847	48780-1	ba0f9c33-3117-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 tablet, for oral use Initial U.S. Approval: 1993
70934-224-30	2021-01-29	C162847	48780-1	ba0f9c33-3117-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 tablet, for oral use Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70934-224-30	Fenofibrate	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70934-224	FENOFIBRATE TABLET, FILM COATED [DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS]	2	Legacy NDC, 1 package rows	20210131_8772816e-4c85-0d07-e053-2a95a90a9c19.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fenofibrate	FENOFIBRATE	Northwind Health Company, LLC	f2f46239-951d-fc0e-e053-2995a90ae979	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200884 application number: ANDA200884
Fenofibrate	FENOFIBRATE	Bryant Ranch Prepack	3db58c5c-b862-4871-b3f9-597aaeba56c4	2025-03-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200884 application number: ANDA200884
Fenofibrate	FENOFIBRATE	Sun Pharmaceutical Industries, Inc.	125bbd7e-86a2-4209-90a5-ad353e572d1b	2025-01-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200884 application number: ANDA200884
Fenofibrate	FENOFIBRATE	A-S Medication Solutions	06870192-c92a-40c7-a619-efda0c006301	2023-04-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200884 application number: ANDA200884

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
U202363UOS	FENOFIBRATE	49562-28-9	FENOFIBRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
477560	fenofibrate 145 MG Oral Tablet	PSN	8772816e-4c85-0d07-e053-2a95a90a9c19	2
477560	fenofibrate 145 MG Oral Tablet	SCD	8772816e-4c85-0d07-e053-2a95a90a9c19	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70934-224-30	70934022430	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-224-30)	2019-01-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fenofibrate	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2021-01-13	HUMAN PRESCRIPTION DRUG LABEL	2