Fenofibrate

Product NDC: 68071-3542
Requested package NDC: 68071-3542-9
11-digit product format: 680713542
Labeler code: 68071
Product ID: 68071-3542_2d3fb146-e3be-92bf-e063-6394a90a1b3a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fenofibrate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA216798
Marketing category: ANDA
Marketing start: 2022-09-27
Substance: FENOFIBRATE
Active strength: 160 mg/1
Pharmacologic classes: Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 3 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-3542	68071-3542-9	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-3542	68071-3542-9	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-3542	68071-3542-9	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`

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
A216798-001	FENOFIBRATE	FENOFIBRATE	54MG	TABLET / ORAL	AB		2022-09-27
A216798-002	FENOFIBRATE	FENOFIBRATE	160MG	TABLET / ORAL	AB		2022-09-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216798-001	AB
A216798-002	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 2 · 52 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	A216798-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2022-09-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216798-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2022-09-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216798-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2022-09-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216798-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2022-09-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216798-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2022-09-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216798-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2022-09-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216798-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2022-09-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216798-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2022-09-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216798-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2022-09-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216798-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2022-09-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216798-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2022-09-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216798-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2022-09-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216798-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2022-09-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216798-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2022-09-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216798-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2022-09-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216798-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2022-09-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216798-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2022-09-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216798-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2022-09-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216798-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2022-09-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216798-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2022-09-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216798-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2022-09-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216798-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2022-09-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216798-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2022-09-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216798-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2022-09-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216798-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2022-09-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216798-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2022-09-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216798-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2022-09-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A216798-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2022-09-27	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216798-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2022-09-27	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216798-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2022-09-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216798-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2022-09-27	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A216798-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2022-09-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216798-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2022-09-27	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A216798-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2022-09-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216798-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2022-09-27	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216798-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2022-09-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216798-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2022-09-27	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216798-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2022-09-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216798-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2022-09-27	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216798-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2022-09-27	`a67488948f0b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 52 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	A216798-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216798-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216798-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216798-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216798-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216798-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216798-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216798-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216798-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216798-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216798-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216798-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216798-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216798-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216798-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216798-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216798-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216798-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216798-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216798-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216798-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216798-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216798-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216798-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216798-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216798-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216798-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A216798-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216798-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216798-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216798-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A216798-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216798-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A216798-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216798-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216798-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216798-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216798-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216798-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216798-002	AB	1	`a67488948f0b…`

Additional Listing Data#

Finished product: Yes
Brand name base: Fenofibrate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FENOFIBRATE	160 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
U202363UOS	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
349287	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0b4e90dd-646b-afec-e063-6294a90a598e	Available on FDA.report

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
68071-3542-9	2025-02-03	C162847	48780-1	2cef2736-701e-d83d-e063-dadaa90ab31f	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
68071-3542-9	2025-01-30	C162847	48780-1	2cef2736-701e-d83d-e063-dadaa90ab31f	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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-3542-9	Fenofibrate	90 in 1 BOTTLE	TABLET, FILM COATED	90		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-3542	FENOFIBRATE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]	2	Current NDC, 1 package rows	20250205_0b4e90dd-646b-afec-e063-6294a90a598e.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fenofibrate	FENOFIBRATE	Bryant Ranch Prepack	bbeae8e4-e06a-4c19-a1b9-f6143306dab9	2026-02-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216798 application number: ANDA216798
Fenofibrate	FENOFIBRATE	A-S Medication Solutions	db3ac584-2c8e-4f69-b24c-96ddcca2c23f	2025-10-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216798 application number: ANDA216798
Fenofibrate	FENOFIBRATE	A-S Medication Solutions	d26e21bf-6c54-437d-81fe-07220e450561	2025-10-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216798 application number: ANDA216798
Fenofibrate	FENOFIBRATE	A-S Medication Solutions	556c4800-24f6-4237-8636-3211997cbb03	2025-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216798 application number: ANDA216798
Fenofibrate	FENOFIBRATE	Preferred Pharmaceuticals Inc.	7792d680-76ee-4146-9451-b16c40656cc1	2025-04-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216798 application number: ANDA216798
Fenofibrate	FENOFIBRATE	Aurobindo Pharma Limited	a7cfa38f-b4db-40d3-8821-3f7c85e2727e	2025-02-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216798 application number: ANDA216798
Fenofibrate	FENOFIBRATE	NuCare Pharmaceuticals,Inc.	0b4e90dd-646b-afec-e063-6294a90a598e	2025-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216798 application number: ANDA216798 ndc (package): 68071-3542-9 ndc (product): 68071-3542 ndc11 (package): 68071354209

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
349287	fenofibrate 160 MG Oral Tablet	PSN	0b4e90dd-646b-afec-e063-6294a90a598e	2
349287	fenofibrate 160 MG Oral Tablet	SCD	0b4e90dd-646b-afec-e063-6294a90a598e	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
68071-3542-9	68071354209	90 TABLET, FILM COATED in 1 BOTTLE (68071-3542-9)	2023-11-29	No	No	Current