Fenofibrate

Product NDC: 60505-3121
11-digit product format: 605053121
Labeler code: 60505
Product ID: 60505-3121_56bf4739-e2a0-0d70-5c99-b4eb473335a6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fenofibrate
Dosage form: CAPSULE
Route: ORAL
Labeler: Apotex Corp.
Application: ANDA202252
Marketing category: ANDA
Marketing start: 2013-07-26
Substance: FENOFIBRATE
Active strength: 130 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 44.

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
A202252-001	FENOFIBRATE (MICRONIZED)	FENOFIBRATE	43MG	CAPSULE / ORAL	AB		2013-07-26
A202252-002	FENOFIBRATE (MICRONIZED)	FENOFIBRATE	130MG	CAPSULE / ORAL	AB		2013-07-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202252-001	AB
A202252-002	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 · 88 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
2026-10-15 13:18:30	2026-09	A202252-001	FENOFIBRATE (MICRONIZED)	43MG	CAPSULE / ORAL	AB	2013-07-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A202252-002	FENOFIBRATE (MICRONIZED)	130MG	CAPSULE / ORAL	AB	2013-07-26	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A202252-001	FENOFIBRATE (MICRONIZED)	43MG	CAPSULE / ORAL	AB	2013-07-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202252-002	FENOFIBRATE (MICRONIZED)	130MG	CAPSULE / ORAL	AB	2013-07-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202252-001	FENOFIBRATE (MICRONIZED)	43MG	CAPSULE / ORAL	AB	2013-07-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202252-002	FENOFIBRATE (MICRONIZED)	130MG	CAPSULE / ORAL	AB	2013-07-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202252-001	FENOFIBRATE (MICRONIZED)	43MG	CAPSULE / ORAL	AB	2013-07-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202252-002	FENOFIBRATE (MICRONIZED)	130MG	CAPSULE / ORAL	AB	2013-07-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202252-001	FENOFIBRATE (MICRONIZED)	43MG	CAPSULE / ORAL	AB	2013-07-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202252-002	FENOFIBRATE (MICRONIZED)	130MG	CAPSULE / ORAL	AB	2013-07-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202252-001	FENOFIBRATE (MICRONIZED)	43MG	CAPSULE / ORAL	AB	2013-07-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202252-002	FENOFIBRATE (MICRONIZED)	130MG	CAPSULE / ORAL	AB	2013-07-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202252-001	FENOFIBRATE (MICRONIZED)	43MG	CAPSULE / ORAL	AB	2013-07-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202252-002	FENOFIBRATE (MICRONIZED)	130MG	CAPSULE / ORAL	AB	2013-07-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202252-001	FENOFIBRATE (MICRONIZED)	43MG	CAPSULE / ORAL	AB	2013-07-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202252-002	FENOFIBRATE (MICRONIZED)	130MG	CAPSULE / ORAL	AB	2013-07-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202252-001	FENOFIBRATE (MICRONIZED)	43MG	CAPSULE / ORAL	AB	2013-07-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202252-002	FENOFIBRATE (MICRONIZED)	130MG	CAPSULE / ORAL	AB	2013-07-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202252-001	FENOFIBRATE (MICRONIZED)	43MG	CAPSULE / ORAL	AB	2013-07-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202252-002	FENOFIBRATE (MICRONIZED)	130MG	CAPSULE / ORAL	AB	2013-07-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202252-001	FENOFIBRATE (MICRONIZED)	43MG	CAPSULE / ORAL	AB	2013-07-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202252-002	FENOFIBRATE (MICRONIZED)	130MG	CAPSULE / ORAL	AB	2013-07-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202252-001	FENOFIBRATE (MICRONIZED)	43MG	CAPSULE / ORAL	AB	2013-07-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202252-002	FENOFIBRATE (MICRONIZED)	130MG	CAPSULE / ORAL	AB	2013-07-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202252-001	FENOFIBRATE (MICRONIZED)	43MG	CAPSULE / ORAL	AB	2013-07-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202252-002	FENOFIBRATE (MICRONIZED)	130MG	CAPSULE / ORAL	AB	2013-07-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202252-001	FENOFIBRATE (MICRONIZED)	43MG	CAPSULE / ORAL	AB	2013-07-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202252-002	FENOFIBRATE (MICRONIZED)	130MG	CAPSULE / ORAL	AB	2013-07-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202252-001	FENOFIBRATE (MICRONIZED)	43MG	CAPSULE / ORAL	AB	2013-07-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202252-002	FENOFIBRATE (MICRONIZED)	130MG	CAPSULE / ORAL	AB	2013-07-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202252-001	FENOFIBRATE (MICRONIZED)	43MG	CAPSULE / ORAL	AB	2013-07-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202252-002	FENOFIBRATE (MICRONIZED)	130MG	CAPSULE / ORAL	AB	2013-07-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202252-001	FENOFIBRATE (MICRONIZED)	43MG	CAPSULE / ORAL	AB	2013-07-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202252-002	FENOFIBRATE (MICRONIZED)	130MG	CAPSULE / ORAL	AB	2013-07-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202252-001	FENOFIBRATE (MICRONIZED)	43MG	CAPSULE / ORAL	AB	2013-07-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202252-002	FENOFIBRATE (MICRONIZED)	130MG	CAPSULE / ORAL	AB	2013-07-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202252-001	FENOFIBRATE (MICRONIZED)	43MG	CAPSULE / ORAL	AB	2013-07-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202252-002	FENOFIBRATE (MICRONIZED)	130MG	CAPSULE / ORAL	AB	2013-07-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202252-001	FENOFIBRATE (MICRONIZED)	43MG	CAPSULE / ORAL	AB	2013-07-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202252-002	FENOFIBRATE (MICRONIZED)	130MG	CAPSULE / ORAL	AB	2013-07-26	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A202252-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A202252-002	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A202252-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202252-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202252-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202252-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202252-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202252-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202252-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202252-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202252-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202252-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202252-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202252-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202252-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202252-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202252-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202252-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202252-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202252-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202252-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202252-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202252-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202252-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202252-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202252-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202252-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202252-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202252-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202252-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202252-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202252-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202252-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202252-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202252-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202252-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202252-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202252-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202252-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202252-002	AB	1	`4b0b4de00fa7…`

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	130 mg/1

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	SPL version
60505-3121-1	Fenofibrate	100 in 1 BOTTLE	CAPSULE	100	14
60505-3121-3	Fenofibrate	30 in 1 BOTTLE	CAPSULE	30	14
60505-3121-5	Fenofibrate	500 in 1 BOTTLE	CAPSULE	500	14
60505-3121-9	Fenofibrate	90 in 1 BOTTLE	CAPSULE	90	14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60505-3121-3	EA - Each	60505-3121	7d7b1fc3-0262-44b7-92bc-2557f481b335	1	2013-10-17
60505-3121-9	EA - Each	60505-3121	f3a30a40-0714-437d-a692-9f0a072ff55c	1	2013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FENOFIBRATE	ACTIVE INGREDIENT	U202363UOS	FENOFIBRATE CAPSULE [APOTEX CORP.]	2
FENOFIBRATE	ACTIVE MOIETY	U202363UOS	FENOFIBRATE CAPSULE [APOTEX CORP.]	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	FENOFIBRATE CAPSULE [APOTEX CORP.]	2
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	FENOFIBRATE CAPSULE [APOTEX CORP.]	2
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	FENOFIBRATE CAPSULE [APOTEX CORP.]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	FENOFIBRATE CAPSULE [APOTEX CORP.]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	FENOFIBRATE CAPSULE [APOTEX CORP.]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	FENOFIBRATE CAPSULE [APOTEX CORP.]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	FENOFIBRATE CAPSULE [APOTEX CORP.]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	FENOFIBRATE CAPSULE [APOTEX CORP.]	2
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	FENOFIBRATE CAPSULE [APOTEX CORP.]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	FENOFIBRATE CAPSULE [APOTEX CORP.]	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	FENOFIBRATE CAPSULE [APOTEX CORP.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	FENOFIBRATE CAPSULE [APOTEX CORP.]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	FENOFIBRATE CAPSULE [APOTEX CORP.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FENOFIBRATE CAPSULE [APOTEX CORP.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60505-3121	FENOFIBRATE CAPSULE [APOTEX CORP.]	12	Current NDC, Legacy NDC, 4 package rows	20240927_68024459-987a-9cf4-f539-4959093bc9f0.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fenofibrate	FENOFIBRATE	Apotex Corp.	68024459-987a-9cf4-f539-4959093bc9f0	2025-10-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202252 application number: ANDA202252 ndc (product): 60505-3121

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	68024459-987a-9cf4-f539-4959093bc9f0	14
483427	fenofibrate 43 MG Oral Capsule	PSN	68024459-987a-9cf4-f539-4959093bc9f0	14
483425	fenofibrate 130 MG Oral Capsule	SCD	68024459-987a-9cf4-f539-4959093bc9f0	14
483427	fenofibrate 43 MG Oral Capsule	SCD	68024459-987a-9cf4-f539-4959093bc9f0	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60505-3121-1	60505312101	100 CAPSULE in 1 BOTTLE (60505-3121-1)	100 capsule	2013-07-26	0000-00-00	No	No	Current
60505-3121-3	60505312103	30 CAPSULE in 1 BOTTLE (60505-3121-3)	30 capsule	2013-07-26	0000-00-00	No	No	Current
60505-3121-5	60505312105	500 CAPSULE in 1 BOTTLE (60505-3121-5)	500 capsule	2013-07-26	0000-00-00	No	No	Current
60505-3121-9	60505312109	90 CAPSULE in 1 BOTTLE (60505-3121-9)	90 capsule	2013-07-26	0000-00-00	No	No	Current