Fenofibrate

Product NDC: 48433-040
11-digit product format: 484330040
Labeler code: 48433
Product ID: 48433-040_4d75e7d7-4d17-6a1e-e063-6294a90a72a6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: fenofibrate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Safecor Health, LLC
Application: ANDA202856
Marketing category: ANDA
Marketing start: 2026-03-17
Substance: FENOFIBRATE
Active strength: 145 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
A202856-001	FENOFIBRATE	FENOFIBRATE	48MG	TABLET / ORAL	AB		2012-12-07
A202856-002	FENOFIBRATE	FENOFIBRATE	145MG	TABLET / ORAL	AB		2012-12-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202856-001	AB
A202856-002	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	A202856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-12-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-12-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-12-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-12-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-12-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-12-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-12-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-12-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-12-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-12-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-12-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-12-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-12-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-12-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-12-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-12-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-12-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-12-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-12-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-12-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-12-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-12-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-12-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-12-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-12-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-12-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-12-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-12-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-12-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-12-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-12-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-12-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-12-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-12-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-12-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-12-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-12-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-12-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202856-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2012-12-07	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202856-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2012-12-07	`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	A202856-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202856-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202856-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202856-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202856-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202856-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202856-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202856-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202856-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202856-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202856-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202856-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202856-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202856-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202856-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202856-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202856-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202856-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202856-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202856-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202856-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202856-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202856-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202856-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202856-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202856-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202856-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202856-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202856-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202856-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202856-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202856-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202856-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202856-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202856-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202856-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202856-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202856-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202856-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202856-002	AB	1	`782e0a99824c…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FENOFIBRATE	145 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
9cc2038d-750e-42dc-b818-c5642cf6a5ad	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
48433-040-01	Fenofibrate	1 in 1 BLISTER PACK	TABLET, FILM COATED	1		2
48433-040-20	Fenofibrate	100 in 1 CARTON	TABLET, FILM COATED	100		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
48433-040-20	EA - Each	48433-040	780580a2-0c47-4ebb-b410-511bad5d6be7	1	2026-05-22

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fenofibrate	FENOFIBRATE	Safecor Health, LLC	9cc2038d-750e-42dc-b818-c5642cf6a5ad	2026-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202856 application number: ANDA202856 ndc (product): 48433-040
Fenofibrate	FENOFIBRATE	Mylan Pharmaceuticals Inc.	0f958942-1504-40a1-8ad8-43df2c3f717e	2025-08-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202856 application number: ANDA202856
Fenofibrate	FENOFIBRATE	Mylan Institutional Inc.	5a90e0a4-7892-462f-9776-037d23a93b10	2025-07-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202856 application number: ANDA202856
Fenofibrate	FENOFIBRATE	A-S Medication Solutions	43aa7e51-443c-4ea0-abf2-f7d9378b3ba9	2024-10-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202856 application number: ANDA202856
Fenofibrate	FENOFIBRATE	A-S Medication Solutions	dd98e467-ecb3-463c-81d8-8b4d89159ab0	2024-02-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202856 application number: ANDA202856
Fenofibrate	FENOFIBRATE	Bryant Ranch Prepack	42b1daf6-1f0e-4464-b160-7c10c492a570	2023-11-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202856 application number: ANDA202856

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	9cc2038d-750e-42dc-b818-c5642cf6a5ad	2
477562	fenofibrate 48 MG Oral Tablet	PSN	9cc2038d-750e-42dc-b818-c5642cf6a5ad	2
477560	fenofibrate 145 MG Oral Tablet	SCD	9cc2038d-750e-42dc-b818-c5642cf6a5ad	2
477562	fenofibrate 48 MG Oral Tablet	SCD	9cc2038d-750e-42dc-b818-c5642cf6a5ad	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
48433-040-01	48433004001	1 in 1 BLISTER PACK					Historical
48433-040-20	48433004020	100 BLISTER PACK in 1 CARTON (48433-040-20) / 1 TABLET, FILM COATED in 1 BLISTER PACK (48433-040-01)	100 blister pack	2026-03-17	No	No	Current