Fenofibrate

Product NDC: 35561-249
11-digit product format: 355610249
Labeler code: 35561
Product ID: 35561-249_4dd565a9-088a-36f9-e063-6394a90ac5e8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fenofibrate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bostal LLC
Application: ANDA208476
Marketing category: ANDA
Marketing start: 2021-01-01
Substance: FENOFIBRATE
Active strength: 48 mg/1
Pharmacologic classes: Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
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
A208476-001	FENOFIBRATE	FENOFIBRATE	48MG	TABLET / ORAL	AB		2021-02-10
A208476-002	FENOFIBRATE	FENOFIBRATE	145MG	TABLET / ORAL	AB		2021-02-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208476-001	AB
A208476-002	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 · 70 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	A208476-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2021-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208476-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2021-02-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208476-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2021-02-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208476-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2021-02-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208476-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2021-02-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208476-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2021-02-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208476-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2021-02-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208476-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2021-02-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208476-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2021-02-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208476-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2021-02-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208476-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2021-02-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208476-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2021-02-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208476-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2021-02-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208476-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2021-02-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208476-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2021-02-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208476-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2021-02-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208476-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2021-02-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208476-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2021-02-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208476-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2021-02-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208476-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2021-02-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208476-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2021-02-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208476-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2021-02-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208476-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2021-02-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208476-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2021-02-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208476-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2021-02-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208476-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2021-02-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208476-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2021-02-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208476-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2021-02-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208476-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2021-02-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208476-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2021-02-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208476-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2021-02-10	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208476-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2021-02-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208476-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2021-02-10	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208476-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2021-02-10	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A208476-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2021-02-10	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208476-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2021-02-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208476-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2021-02-10	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A208476-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2021-02-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208476-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2021-02-10	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208476-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2021-02-10	`87673890dc5c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 70 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	A208476-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208476-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208476-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208476-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208476-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208476-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208476-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208476-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208476-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208476-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208476-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208476-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208476-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208476-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208476-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208476-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208476-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208476-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208476-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208476-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208476-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208476-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208476-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208476-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208476-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208476-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208476-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208476-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208476-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208476-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208476-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208476-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208476-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208476-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A208476-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208476-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208476-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A208476-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208476-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208476-002	AB	1	`87673890dc5c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Fenofibrate
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FENOFIBRATE	48 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
477560	Internal RxNorm lookup
477562	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
7eb328d0-4e6f-4b24-ae85-68c2b3657569	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
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
cfc78bfa-7d55-47e5-aeb7-71cd79f5ca07	Product name	8	20231212
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
53d5b6b7-785a-4500-9460-263c7f8424b8	Product name	5	20210105
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
ed9d55d4-85bd-0ee7-5b4a-b705646a3a66	Product name	9	20200708
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
36a239c8-03fb-0083-81af-6c1afb195671	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
a0296d70-ca85-018c-84e8-cf3f630976b7	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	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	SPL version
35561-249-03	Fenofibrate	500 in 1 BOTTLE	TABLET, FILM COATED	500	11
35561-249-10	Fenofibrate	30 in 1 BOTTLE	TABLET, FILM COATED	30	11
35561-249-11	Fenofibrate	90 in 1 BOTTLE	TABLET, FILM COATED	90	11
35561-249-13	Fenofibrate	500 in 1 BOTTLE	TABLET, FILM COATED	500	11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
35561-249	FENOFIBRATE TABLET, FILM COATED [AUSTARPHARMA, LLC]	7	Current NDC, 4 package rows	20240925_7eb328d0-4e6f-4b24-ae85-68c2b3657569.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fenofibrate	FENOFIBRATE	Bostal LLC	7eb328d0-4e6f-4b24-ae85-68c2b3657569	2026-06-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208476 application number: ANDA208476 ndc (product): 35561-249
Fenofibrate	FENOFIBRATE	Golden State Medical Supply, Inc.	3e611f91-e351-9558-e063-6394a90ace17	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208476 application number: ANDA208476

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	7eb328d0-4e6f-4b24-ae85-68c2b3657569	11
477562	fenofibrate 48 MG Oral Tablet	PSN	7eb328d0-4e6f-4b24-ae85-68c2b3657569	11
477560	fenofibrate 145 MG Oral Tablet	SCD	7eb328d0-4e6f-4b24-ae85-68c2b3657569	11
477562	fenofibrate 48 MG Oral Tablet	SCD	7eb328d0-4e6f-4b24-ae85-68c2b3657569	11
477560	fenofibrate 145 MG Oral Tablet	PSN	3e611f91-e351-9558-e063-6394a90ace17	3
477562	fenofibrate 48 MG Oral Tablet	PSN	3e611f91-e351-9558-e063-6394a90ace17	3
477560	fenofibrate 145 MG Oral Tablet	SCD	3e611f91-e351-9558-e063-6394a90ace17	3
477562	fenofibrate 48 MG Oral Tablet	SCD	3e611f91-e351-9558-e063-6394a90ace17	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
35561-249-03	35561024903	500 TABLET, FILM COATED in 1 BOTTLE (35561-249-03)	2025-08-07	No	No	Current
35561-249-10	35561024910	30 TABLET, FILM COATED in 1 BOTTLE (35561-249-10)	2021-01-01	No	No	Current
35561-249-11	35561024911	90 TABLET, FILM COATED in 1 BOTTLE (35561-249-11)	2025-08-15	No	No	Current
35561-249-13	35561024913	500 TABLET, FILM COATED in 1 BOTTLE (35561-249-13)	2021-01-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fenofibrate	Bostal LLC	2026-06-30	HUMAN PRESCRIPTION DRUG LABEL	12
Fenofibrate	Golden State Medical Supply, Inc.	2026-04-15	HUMAN PRESCRIPTION DRUG LABEL	3