FENOFIBRATE

Product NDC: 0904-7539
11-digit product format: 009047539
Labeler code: 0904
Product ID: 0904-7539_9eb677e7-08d9-40a3-b983-21fa58b42296
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: FENOFIBRATE
Dosage form: TABLET
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA213864
Marketing category: ANDA
Marketing start: 2025-05-22
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

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
A213864-001	FENOFIBRATE	FENOFIBRATE	54MG	TABLET / ORAL	AB		2020-06-12
A213864-002	FENOFIBRATE	FENOFIBRATE	160MG	TABLET / ORAL	AB		2020-06-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213864-001	AB
A213864-002	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 · 74 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	A213864-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2020-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213864-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2020-06-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213864-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2020-06-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213864-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2020-06-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213864-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2020-06-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213864-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2020-06-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213864-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2020-06-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213864-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2020-06-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213864-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2020-06-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213864-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2020-06-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213864-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2020-06-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213864-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2020-06-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213864-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2020-06-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213864-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2020-06-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213864-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2020-06-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213864-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2020-06-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213864-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2020-06-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213864-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2020-06-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213864-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2020-06-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213864-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2020-06-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213864-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2020-06-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213864-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2020-06-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213864-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2020-06-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213864-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2020-06-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213864-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2020-06-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213864-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2020-06-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213864-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2020-06-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213864-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2020-06-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213864-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2020-06-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213864-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2020-06-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213864-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2020-06-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213864-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2020-06-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213864-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2020-06-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213864-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2020-06-12	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213864-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2020-06-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213864-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2020-06-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213864-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2020-06-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213864-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2020-06-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213864-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2020-06-12	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213864-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2020-06-12	`87673890dc5c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 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	A213864-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213864-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213864-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213864-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213864-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213864-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213864-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213864-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213864-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213864-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213864-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213864-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213864-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213864-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213864-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213864-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213864-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213864-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213864-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213864-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213864-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213864-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213864-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213864-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213864-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213864-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213864-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213864-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213864-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213864-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213864-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213864-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213864-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213864-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213864-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213864-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213864-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213864-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213864-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213864-002	AB	1	`87673890dc5c…`

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
3f4e5db8-5bfb-4b24-8465-9757cbaad2be	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0904-7539-04	FENOFIBRATE	30 in 1 CARTON	TABLET	30		2
0904-7539-04	FENOFIBRATE	1 in 1 BLISTER PACK	TABLET	1		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-7539-04	EA - Each	0904-7539	224a51fb-67df-48aa-93fd-fdd3f2f66d68	1	2025-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-7539	FENOFIBRATE TABLET [MAJOR PHARMACEUTICALS]	1	Current NDC, 2 package rows	20250523_3f4e5db8-5bfb-4b24-8465-9757cbaad2be.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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FENOFIBRATE	FENOFIBRATE	REMEDYREPACK INC.	3b6c5ebd-a8bc-4502-8b66-f4e58914815b	2026-07-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213864 application number: ANDA213864
FENOFIBRATE	FENOFIBRATE	St. Mary's Medical Park Pharmacy	b92fb19a-d0df-426e-e053-2995a90ab379	2026-06-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213864 application number: ANDA213864
FENOFIBRATE	FENOFIBRATE	A-S Medication Solutions	df9f67d6-3cd9-4f44-8020-2d6ef53c30b5	2026-05-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213864 application number: ANDA213864
FENOFIBRATE	FENOFIBRATE	Preferred Pharmaceuticals Inc.	e573b3f1-5a4c-4a19-9f0f-ee797b379a08	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213864 application number: ANDA213864
FENOFIBRATE	FENOFIBRATE	A-S Medication Solutions	f443dd79-46da-4b02-8188-7417d39cf975	2026-03-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213864 application number: ANDA213864
FENOFIBRATE	FENOFIBRATE	REMEDYREPACK INC.	b79efcf4-6016-4a1f-b83f-be00baa25c21	2026-02-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213864 application number: ANDA213864
FENOFIBRATE	FENOFIBRATE	Northwind Health Company, LLC	f7590970-c54d-24e9-e053-6294a90ac400	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213864 application number: ANDA213864
FENOFIBRATE	FENOFIBRATE	NorthStar RxLLC	3b448774-aebf-45fe-92f1-b8eca53cf09b	2025-09-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213864 application number: ANDA213864
FENOFIBRATE	FENOFIBRATE	Major Pharmaceuticals	3f4e5db8-5bfb-4b24-8465-9757cbaad2be	2025-06-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213864 application number: ANDA213864 ndc (product): 0904-7539
FENOFIBRATE	FENOFIBRATE	Lifestar Pharma LLC	1da57e8c-3977-43e1-aa7e-229760203f7d	2025-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213864 application number: ANDA213864
FENOFIBRATE	FENOFIBRATE	Bryant Ranch Prepack	d34f9fa3-39ae-4b8e-8f29-0d5c655c50b5	2023-03-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213864 application number: ANDA213864
FENOFIBRATE	FENOFIBRATE	Proficient Rx LP	26f8f793-fb7a-4327-9441-d8737fe1ff11	2022-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213864 application number: ANDA213864

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	3f4e5db8-5bfb-4b24-8465-9757cbaad2be	2
349287	fenofibrate 160 MG Oral Tablet	SCD	3f4e5db8-5bfb-4b24-8465-9757cbaad2be	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0904-7539-04	00904753904	30 BLISTER PACK in 1 CARTON (0904-7539-04) / 1 TABLET in 1 BLISTER PACK	30 blister pack	2025-05-22	No	No	Current