Fenofibrate

Product NDC: 63304-443
11-digit product format: 633040443
Labeler code: 63304
Product ID: 63304-443_54973b69-606a-d32e-e063-6394a90a997b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fenofibrate
Dosage form: CAPSULE
Route: ORAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA201748
Marketing category: ANDA
Marketing start: 2015-03-02
Substance: FENOFIBRATE
Active strength: 43 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 43.

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
A201748-001	FENOFIBRATE (MICRONIZED)	FENOFIBRATE	43MG	CAPSULE / ORAL			2014-10-31
A201748-002	FENOFIBRATE (MICRONIZED)	FENOFIBRATE	130MG	CAPSULE / ORAL			2014-10-31

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 · 86 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
2026-09-14 22:38:34	2026-08	A201748-001	FENOFIBRATE (MICRONIZED)	43MG	CAPSULE / ORAL		2014-10-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201748-002	FENOFIBRATE (MICRONIZED)	130MG	CAPSULE / ORAL		2014-10-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A201748-001	FENOFIBRATE (MICRONIZED)	43MG	CAPSULE / ORAL		2014-10-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201748-002	FENOFIBRATE (MICRONIZED)	130MG	CAPSULE / ORAL		2014-10-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201748-001	FENOFIBRATE (MICRONIZED)	43MG	CAPSULE / ORAL		2014-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201748-002	FENOFIBRATE (MICRONIZED)	130MG	CAPSULE / ORAL		2014-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201748-001	FENOFIBRATE (MICRONIZED)	43MG	CAPSULE / ORAL		2014-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201748-002	FENOFIBRATE (MICRONIZED)	130MG	CAPSULE / ORAL		2014-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201748-001	FENOFIBRATE	43MG	CAPSULE / ORAL	AB	2014-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201748-002	FENOFIBRATE	130MG	CAPSULE / ORAL	AB	2014-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201748-001	FENOFIBRATE	43MG	CAPSULE / ORAL	AB	2014-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201748-002	FENOFIBRATE	130MG	CAPSULE / ORAL	AB	2014-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201748-001	FENOFIBRATE	43MG	CAPSULE / ORAL	AB	2014-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201748-002	FENOFIBRATE	130MG	CAPSULE / ORAL	AB	2014-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201748-001	FENOFIBRATE	43MG	CAPSULE / ORAL	AB	2014-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201748-002	FENOFIBRATE	130MG	CAPSULE / ORAL	AB	2014-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201748-001	FENOFIBRATE	43MG	CAPSULE / ORAL	AB	2014-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201748-002	FENOFIBRATE	130MG	CAPSULE / ORAL	AB	2014-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201748-001	FENOFIBRATE	43MG	CAPSULE / ORAL	AB	2014-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201748-002	FENOFIBRATE	130MG	CAPSULE / ORAL	AB	2014-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201748-001	FENOFIBRATE	43MG	CAPSULE / ORAL	AB	2014-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201748-002	FENOFIBRATE	130MG	CAPSULE / ORAL	AB	2014-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201748-001	FENOFIBRATE	43MG	CAPSULE / ORAL	AB	2014-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201748-002	FENOFIBRATE	130MG	CAPSULE / ORAL	AB	2014-10-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201748-001	FENOFIBRATE	43MG	CAPSULE / ORAL	AB	2014-10-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201748-002	FENOFIBRATE	130MG	CAPSULE / ORAL	AB	2014-10-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201748-001	FENOFIBRATE	43MG	CAPSULE / ORAL	AB	2014-10-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201748-002	FENOFIBRATE	130MG	CAPSULE / ORAL	AB	2014-10-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201748-001	FENOFIBRATE	43MG	CAPSULE / ORAL	AB	2014-10-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201748-002	FENOFIBRATE	130MG	CAPSULE / ORAL	AB	2014-10-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201748-001	FENOFIBRATE	43MG	CAPSULE / ORAL	AB	2014-10-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201748-002	FENOFIBRATE	130MG	CAPSULE / ORAL	AB	2014-10-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201748-001	FENOFIBRATE	43MG	CAPSULE / ORAL	AB	2014-10-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201748-002	FENOFIBRATE	130MG	CAPSULE / ORAL	AB	2014-10-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201748-001	FENOFIBRATE	43MG	CAPSULE / ORAL	AB	2014-10-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201748-002	FENOFIBRATE	130MG	CAPSULE / ORAL	AB	2014-10-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201748-001	FENOFIBRATE	43MG	CAPSULE / ORAL	AB	2014-10-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201748-002	FENOFIBRATE	130MG	CAPSULE / ORAL	AB	2014-10-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201748-001	FENOFIBRATE	43MG	CAPSULE / ORAL	AB	2014-10-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201748-002	FENOFIBRATE	130MG	CAPSULE / ORAL	AB	2014-10-31	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A201748-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201748-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201748-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201748-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201748-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201748-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201748-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201748-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201748-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201748-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201748-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201748-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201748-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201748-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201748-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201748-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201748-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201748-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201748-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201748-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201748-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201748-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201748-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201748-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201748-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201748-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201748-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201748-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201748-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201748-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201748-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201748-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201748-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201748-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201748-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201748-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201748-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201748-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201748-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A201748-002	AB	1	`5aa47cf7b7d7…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FENOFIBRATE	43 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
483425	Internal RxNorm lookup
483427	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
2083f5d9-92f2-4c64-b996-fabbd6946ea0	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
63304-443-05	Fenofibrate	500 in 1 BOTTLE	CAPSULE	500		11
63304-443-30	Fenofibrate	30 in 1 BOTTLE	CAPSULE	30		11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63304-443-30	EA - Each	63304-443	d5159885-8d57-4105-a0f2-e5dcaddf1a71	1	2015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FENOFIBRATE	ACTIVE INGREDIENT	U202363UOS	FENOFIBRATE CAPSULE [RANBAXY PHARMACEUTICALS INC.]	4
FENOFIBRATE	ACTIVE MOIETY	U202363UOS	FENOFIBRATE CAPSULE [RANBAXY PHARMACEUTICALS INC.]	4
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	FENOFIBRATE CAPSULE [RANBAXY PHARMACEUTICALS INC.]	4
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	FENOFIBRATE CAPSULE [RANBAXY PHARMACEUTICALS INC.]	4
GELATIN	INACTIVE INGREDIENT	2G86QN327L	FENOFIBRATE CAPSULE [RANBAXY PHARMACEUTICALS INC.]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	FENOFIBRATE CAPSULE [RANBAXY PHARMACEUTICALS INC.]	4
POLYSORBATE 65	INACTIVE INGREDIENT	14BGY2Y3MJ	FENOFIBRATE CAPSULE [RANBAXY PHARMACEUTICALS INC.]	4
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	FENOFIBRATE CAPSULE [RANBAXY PHARMACEUTICALS INC.]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	FENOFIBRATE CAPSULE [RANBAXY PHARMACEUTICALS INC.]	4
SHELLAC	INACTIVE INGREDIENT	46N107B71O	FENOFIBRATE CAPSULE [RANBAXY PHARMACEUTICALS INC.]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	FENOFIBRATE CAPSULE [RANBAXY PHARMACEUTICALS INC.]	4
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	FENOFIBRATE CAPSULE [RANBAXY PHARMACEUTICALS INC.]	4
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	FENOFIBRATE CAPSULE [RANBAXY PHARMACEUTICALS INC.]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	FENOFIBRATE CAPSULE [RANBAXY PHARMACEUTICALS INC.]	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	FENOFIBRATE CAPSULE [RANBAXY PHARMACEUTICALS INC.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FENOFIBRATE CAPSULE [RANBAXY PHARMACEUTICALS INC.]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	FENOFIBRATE CAPSULE [RANBAXY PHARMACEUTICALS INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63304-443	FENOFIBRATE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES, INC.]	10	Current NDC, Legacy NDC, 2 package rows	20240830_2083f5d9-92f2-4c64-b996-fabbd6946ea0.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	Sun Pharmaceutical Industries, Inc.	2083f5d9-92f2-4c64-b996-fabbd6946ea0	2026-06-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201748 application number: ANDA201748 ndc (product): 63304-443
Fenofibrate	FENOFIBRATE	PD-Rx Pharmaceuticals, Inc.	2f5cee5c-ec55-4e9b-9d54-e7f2f052130e	2026-02-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201748 application number: ANDA201748

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
483425	fenofibrate 130 MG Oral Capsule	PSN	2083f5d9-92f2-4c64-b996-fabbd6946ea0	11
483427	fenofibrate 43 MG Oral Capsule	PSN	2083f5d9-92f2-4c64-b996-fabbd6946ea0	11
483425	fenofibrate 130 MG Oral Capsule	SCD	2083f5d9-92f2-4c64-b996-fabbd6946ea0	11
483427	fenofibrate 43 MG Oral Capsule	SCD	2083f5d9-92f2-4c64-b996-fabbd6946ea0	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63304-443-05	63304044305	500 CAPSULE in 1 BOTTLE (63304-443-05)	500 capsule	2015-03-02	0000-00-00	No	No	Current
63304-443-30	63304044330	30 CAPSULE in 1 BOTTLE (63304-443-30)	30 capsule	2015-03-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fenofibrate	Sun Pharmaceutical Industries, Inc. \| Ohm Laboratories Inc.	2026-06-19	HUMAN PRESCRIPTION DRUG LABEL	12