FENOFIBRATE

Product NDC: 0115-5511
11-digit product format: 001155511
Labeler code: 0115
Product ID: 0115-5511_71bb776c-1208-4049-bba2-0f9eb1ea4efe
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: FENOFIBRATE
Dosage form: TABLET
Route: ORAL
Labeler: Amneal Pharmaceuticals of New York LLC
Application: ANDA076509
Marketing category: ANDA
Marketing start: 2010-02-01
Substance: FENOFIBRATE
Active strength: 54 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
A076509-001	FENOFIBRATE	FENOFIBRATE	54MG	TABLET / ORAL	AB		2008-03-26
A076509-002	FENOFIBRATE	FENOFIBRATE	160MG	TABLET / ORAL	AB	RS	2008-03-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076509-001	AB
A076509-002	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076509-001	FENOFIBRATE	54MG	TABLET / ORAL	AB		2008-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076509-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	RS	2008-03-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076509-001	FENOFIBRATE	54MG	TABLET / ORAL	AB		2008-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076509-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	RS	2008-03-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076509-001	FENOFIBRATE	54MG	TABLET / ORAL	AB		2008-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076509-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	RS	2008-03-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076509-001	FENOFIBRATE	54MG	TABLET / ORAL	AB		2008-03-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076509-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	RS	2008-03-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076509-001	FENOFIBRATE	54MG	TABLET / ORAL	AB		2008-03-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076509-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	RS	2008-03-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076509-001	FENOFIBRATE	54MG	TABLET / ORAL	AB		2008-03-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076509-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	RS	2008-03-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076509-001	FENOFIBRATE	54MG	TABLET / ORAL	AB		2008-03-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076509-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	RS	2008-03-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076509-001	FENOFIBRATE	54MG	TABLET / ORAL	AB		2008-03-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076509-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	RS	2008-03-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076509-001	FENOFIBRATE	54MG	TABLET / ORAL	AB		2008-03-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076509-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	RS	2008-03-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076509-001	FENOFIBRATE	54MG	TABLET / ORAL	AB		2008-03-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076509-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	RS	2008-03-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076509-001	FENOFIBRATE	54MG	TABLET / ORAL	AB		2008-03-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076509-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	RS	2008-03-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076509-001	FENOFIBRATE	54MG	TABLET / ORAL	AB		2008-03-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076509-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	RS	2008-03-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076509-001	FENOFIBRATE	54MG	TABLET / ORAL	AB		2008-03-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076509-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	RS	2008-03-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076509-001	FENOFIBRATE	54MG	TABLET / ORAL	AB		2008-03-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076509-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	RS	2008-03-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076509-001	FENOFIBRATE	54MG	TABLET / ORAL	AB		2008-03-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076509-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	RS	2008-03-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076509-001	FENOFIBRATE	54MG	TABLET / ORAL	AB		2008-03-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076509-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	RS	2008-03-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076509-001	FENOFIBRATE	54MG	TABLET / ORAL	AB		2008-03-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076509-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	RS	2008-03-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076509-001	FENOFIBRATE	54MG	TABLET / ORAL	AB		2008-03-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076509-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	RS	2008-03-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076509-001	FENOFIBRATE	54MG	TABLET / ORAL	AB		2008-03-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076509-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	RS	2008-03-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076509-001	FENOFIBRATE	54MG	TABLET / ORAL	AB		2008-03-26	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076509-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	RS	2008-03-26	`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	A076509-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076509-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076509-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076509-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076509-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076509-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076509-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076509-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076509-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076509-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076509-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076509-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076509-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076509-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076509-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076509-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076509-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076509-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076509-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076509-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076509-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076509-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076509-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076509-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076509-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076509-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076509-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076509-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076509-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076509-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076509-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076509-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076509-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076509-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076509-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076509-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076509-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076509-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076509-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076509-002	AB	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: FENOFIBRATE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FENOFIBRATE	54 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
349287	Internal RxNorm lookup
351133	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
fa08cf6a-d306-4979-9b23-ac7febf4fd12	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
0115-5511-01	2024-01-01	These highlights do not include all the information needed to use FENOFIBRATE TABLETS safely and effectively. See full prescribing information for FENOFIBRATE TABLETS. FENOFIBRATE tablets, for oral use Initial U.S. Approval: 1993
0115-5511-02	2024-01-01	These highlights do not include all the information needed to use FENOFIBRATE TABLETS safely and effectively. See full prescribing information for FENOFIBRATE TABLETS. FENOFIBRATE tablets, for oral use Initial U.S. Approval: 1993
0115-5511-03	2024-01-01	These highlights do not include all the information needed to use FENOFIBRATE TABLETS safely and effectively. See full prescribing information for FENOFIBRATE TABLETS. FENOFIBRATE tablets, for oral use Initial U.S. Approval: 1993
0115-5511-10	2024-01-01	These highlights do not include all the information needed to use FENOFIBRATE TABLETS safely and effectively. See full prescribing information for FENOFIBRATE TABLETS. FENOFIBRATE tablets, for oral use Initial U.S. Approval: 1993
0115-5511-01	2023-07-28	These highlights do not include all the information needed to use FENOFIBRATE TABLETS safely and effectively. See full prescribing information for FENOFIBRATE TABLETS. FENOFIBRATE tablets, for oral use Initial U.S. Approval: 1993
0115-5511-02	2023-07-28	These highlights do not include all the information needed to use FENOFIBRATE TABLETS safely and effectively. See full prescribing information for FENOFIBRATE TABLETS. FENOFIBRATE tablets, for oral use Initial U.S. Approval: 1993
0115-5511-03	2023-07-28	These highlights do not include all the information needed to use FENOFIBRATE TABLETS safely and effectively. See full prescribing information for FENOFIBRATE TABLETS. FENOFIBRATE tablets, for oral use Initial U.S. Approval: 1993
0115-5511-10	2023-07-28	These highlights do not include all the information needed to use FENOFIBRATE TABLETS safely and effectively. See full prescribing information for FENOFIBRATE TABLETS. FENOFIBRATE tablets, for oral use Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0115-5511-01	FENOFIBRATE	100 in 1 BOTTLE	TABLET	100	38
0115-5511-02	FENOFIBRATE	500 in 1 BOTTLE	TABLET	500	38
0115-5511-03	FENOFIBRATE	1000 in 1 BOTTLE	TABLET	1000	38
0115-5511-10	FENOFIBRATE	90 in 1 BOTTLE	TABLET	90	38

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0115-5511-10	EA - Each	0115-5511	4853e0d9-5dd4-4fb2-a644-1006294d2517	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FENOFIBRATE	ACTIVE INGREDIENT	U202363UOS	FENOFIBRATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]	10
FENOFIBRATE	ACTIVE MOIETY	U202363UOS	FENOFIBRATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]	10
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	FENOFIBRATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]	10
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	FENOFIBRATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]	10
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	FENOFIBRATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]	10
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	FENOFIBRATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]	10
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	FENOFIBRATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]	10
HYPROMELLOSE 2910 (50 MPA.S)	INACTIVE INGREDIENT	1IVH67816N	FENOFIBRATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]	10
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	FENOFIBRATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]	10
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	FENOFIBRATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]	10
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FENOFIBRATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]	10
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	FENOFIBRATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]	10
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	FENOFIBRATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]	10
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FENOFIBRATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]	10
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	FENOFIBRATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]	10
FENOFIBRATE	ACTIVE INGREDIENT	U202363UOS	FENOFIBRATE TABLET [KAISER FOUNDATION HOSPITALS]	8
FENOFIBRATE	ACTIVE MOIETY	U202363UOS	FENOFIBRATE TABLET [KAISER FOUNDATION HOSPITALS]	8
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	FENOFIBRATE TABLET [KAISER FOUNDATION HOSPITALS]	8
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	FENOFIBRATE TABLET [KAISER FOUNDATION HOSPITALS]	8
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	FENOFIBRATE TABLET [KAISER FOUNDATION HOSPITALS]	8
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	FENOFIBRATE TABLET [KAISER FOUNDATION HOSPITALS]	8
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	FENOFIBRATE TABLET [KAISER FOUNDATION HOSPITALS]	8
HYPROMELLOSE 2910 (50 MPA.S)	INACTIVE INGREDIENT	1IVH67816N	FENOFIBRATE TABLET [KAISER FOUNDATION HOSPITALS]	8
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	FENOFIBRATE TABLET [KAISER FOUNDATION HOSPITALS]	8
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	FENOFIBRATE TABLET [KAISER FOUNDATION HOSPITALS]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FENOFIBRATE TABLET [KAISER FOUNDATION HOSPITALS]	8
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	FENOFIBRATE TABLET [KAISER FOUNDATION HOSPITALS]	8
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	FENOFIBRATE TABLET [KAISER FOUNDATION HOSPITALS]	8
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	FENOFIBRATE TABLET [KAISER FOUNDATION HOSPITALS]	8
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FENOFIBRATE TABLET [KAISER FOUNDATION HOSPITALS]	8
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	FENOFIBRATE TABLET [KAISER FOUNDATION HOSPITALS]	8
FENOFIBRATE	ACTIVE INGREDIENT	U202363UOS	FENOFIBRATE TABLET [AMERICAN HEALTH PACKAGING]	6
FENOFIBRATE	ACTIVE MOIETY	U202363UOS	FENOFIBRATE TABLET [AMERICAN HEALTH PACKAGING]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	FENOFIBRATE TABLET [AMERICAN HEALTH PACKAGING]	6
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	FENOFIBRATE TABLET [AMERICAN HEALTH PACKAGING]	6
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	FENOFIBRATE TABLET [AMERICAN HEALTH PACKAGING]	6
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	FENOFIBRATE TABLET [AMERICAN HEALTH PACKAGING]	6
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	FENOFIBRATE TABLET [AMERICAN HEALTH PACKAGING]	6
HYPROMELLOSE 2910 (50 MPA.S)	INACTIVE INGREDIENT	1IVH67816N	FENOFIBRATE TABLET [AMERICAN HEALTH PACKAGING]	6
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	FENOFIBRATE TABLET [AMERICAN HEALTH PACKAGING]	6
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	FENOFIBRATE TABLET [AMERICAN HEALTH PACKAGING]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FENOFIBRATE TABLET [AMERICAN HEALTH PACKAGING]	6
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	FENOFIBRATE TABLET [AMERICAN HEALTH PACKAGING]	6
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	FENOFIBRATE TABLET [AMERICAN HEALTH PACKAGING]	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FENOFIBRATE TABLET [AMERICAN HEALTH PACKAGING]	6
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	FENOFIBRATE TABLET [AMERICAN HEALTH PACKAGING]	6
FENOFIBRATE	ACTIVE INGREDIENT	U202363UOS	FENOFIBRATE (FENOFIBRATE) TABLET [AVKARE, INC.]	2
FENOFIBRATE	ACTIVE INGREDIENT	U202363UOS	FENOFIBRATE TABLET [PHYSICIANS TOTAL CARE, INC.]	2
FENOFIBRATE	ACTIVE MOIETY	U202363UOS	FENOFIBRATE TABLET [PHYSICIANS TOTAL CARE, INC.]	2
FENOFIBRATE	ACTIVE MOIETY	U202363UOS	FENOFIBRATE (FENOFIBRATE) TABLET [AVKARE, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	FENOFIBRATE TABLET [PHYSICIANS TOTAL CARE, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	FENOFIBRATE (FENOFIBRATE) TABLET [AVKARE, INC.]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	FENOFIBRATE (FENOFIBRATE) TABLET [AVKARE, INC.]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	FENOFIBRATE TABLET [PHYSICIANS TOTAL CARE, INC.]	2
D&c Yellow No. 10	INACTIVE INGREDIENT	35SW5USQ3G	FENOFIBRATE (FENOFIBRATE) TABLET [AVKARE, INC.]	2
Fd&c Yellow No. 6	INACTIVE INGREDIENT	H77VEI93A8	FENOFIBRATE (FENOFIBRATE) TABLET [AVKARE, INC.]	2
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	FENOFIBRATE (FENOFIBRATE) TABLET [AVKARE, INC.]	2
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	FENOFIBRATE TABLET [PHYSICIANS TOTAL CARE, INC.]	2
HYPROMELLOSE 2910 (50 MPA.S)	INACTIVE INGREDIENT	1IVH67816N	FENOFIBRATE TABLET [PHYSICIANS TOTAL CARE, INC.]	2
HYPROMELLOSE 2910 (50 MPA.S)	INACTIVE INGREDIENT	1IVH67816N	FENOFIBRATE (FENOFIBRATE) TABLET [AVKARE, INC.]	2
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	FENOFIBRATE TABLET [PHYSICIANS TOTAL CARE, INC.]	2
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	FENOFIBRATE (FENOFIBRATE) TABLET [AVKARE, INC.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	FENOFIBRATE TABLET [PHYSICIANS TOTAL CARE, INC.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	FENOFIBRATE (FENOFIBRATE) TABLET [AVKARE, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FENOFIBRATE TABLET [PHYSICIANS TOTAL CARE, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FENOFIBRATE (FENOFIBRATE) TABLET [AVKARE, INC.]	2
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	FENOFIBRATE TABLET [PHYSICIANS TOTAL CARE, INC.]	2
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	FENOFIBRATE (FENOFIBRATE) TABLET [AVKARE, INC.]	2
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	FENOFIBRATE TABLET [PHYSICIANS TOTAL CARE, INC.]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	FENOFIBRATE (FENOFIBRATE) TABLET [AVKARE, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FENOFIBRATE TABLET [PHYSICIANS TOTAL CARE, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FENOFIBRATE (FENOFIBRATE) TABLET [AVKARE, INC.]	2
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	FENOFIBRATE TABLET [PHYSICIANS TOTAL CARE, INC.]	2
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	FENOFIBRATE (FENOFIBRATE) TABLET [AVKARE, INC.]	2
FENOFIBRATE	ACTIVE INGREDIENT	U202363UOS	FENOFIBRATE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
FENOFIBRATE	ACTIVE MOIETY	U202363UOS	FENOFIBRATE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	FENOFIBRATE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	FENOFIBRATE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	FENOFIBRATE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	FENOFIBRATE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	FENOFIBRATE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
HYPROMELLOSE 2910 (50 MPA.S)	INACTIVE INGREDIENT	1IVH67816N	FENOFIBRATE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	FENOFIBRATE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	FENOFIBRATE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FENOFIBRATE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	FENOFIBRATE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	FENOFIBRATE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FENOFIBRATE TABLET [AIDAREX PHARMACEUTICALS LLC]	1
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	FENOFIBRATE TABLET [AIDAREX PHARMACEUTICALS LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0115-5511	FENOFIBRATE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]	38	Current NDC, Legacy NDC, 4 package rows	20240102_fa08cf6a-d306-4979-9b23-ac7febf4fd12.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FENOFIBRATE	FENOFIBRATE	Amneal Pharmaceuticals LLC	65f5dcad-5073-4347-9ec9-e7f350b134c4	2026-06-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076509 application number: ANDA076509
FENOFIBRATE	FENOFIBRATE	Northwind Health Company, LLC	4b4447a1-8136-4258-b2c8-c5f9c1bcec92	2025-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076509 application number: ANDA076509
FENOFIBRATE	FENOFIBRATE	AvPAK	d4e1d692-3c03-7406-ee06-7a6fb39ed3e7	2025-11-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076509 application number: ANDA076509
FENOFIBRATE	FENOFIBRATE	REMEDYREPACK INC.	882ee82a-3c56-4173-af42-68c3aadc8aa7	2025-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076509 application number: ANDA076509
FENOFIBRATE	FENOFIBRATE	PD-Rx Pharmaceuticals, Inc.	35ba17d9-0dd7-4f15-8f74-be5fd15f1917	2025-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076509 application number: ANDA076509
FENOFIBRATE	FENOFIBRATE	A-S Medication Solutions	3f2b3a16-7735-487e-9a2c-e078a18df1bc	2024-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076509 application number: ANDA076509
FENOFIBRATE	FENOFIBRATE	A-S Medication Solutions	f937a176-3d3e-4dc6-a7d4-c1a4749c7a7f	2023-12-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076509 application number: ANDA076509
FENOFIBRATE	FENOFIBRATE	Amneal Pharmaceuticals of New York LLC	fa08cf6a-d306-4979-9b23-ac7febf4fd12	2021-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076509 application number: ANDA076509 ndc (product): 0115-5511

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	fa08cf6a-d306-4979-9b23-ac7febf4fd12	38
351133	fenofibrate 54 MG Oral Tablet	PSN	fa08cf6a-d306-4979-9b23-ac7febf4fd12	38
349287	fenofibrate 160 MG Oral Tablet	SCD	fa08cf6a-d306-4979-9b23-ac7febf4fd12	38
351133	fenofibrate 54 MG Oral Tablet	SCD	fa08cf6a-d306-4979-9b23-ac7febf4fd12	38
349287	fenofibrate 160 MG Oral Tablet	PSN	2e51aa89-684d-451e-b513-12b00bf9aea0	2
351133	fenofibrate 54 MG Oral Tablet	PSN	2e51aa89-684d-451e-b513-12b00bf9aea0	2
349287	fenofibrate 160 MG Oral Tablet	SCD	2e51aa89-684d-451e-b513-12b00bf9aea0	2
351133	fenofibrate 54 MG Oral Tablet	SCD	2e51aa89-684d-451e-b513-12b00bf9aea0	2
351133	fenofibrate 54 MG Oral Tablet	PSN	b4ae2a4c-68f7-468e-9951-4dd11dd8c33d	1
351133	fenofibrate 54 MG Oral Tablet	SCD	b4ae2a4c-68f7-468e-9951-4dd11dd8c33d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0115-5511-01	00115551101	100 TABLET in 1 BOTTLE (0115-5511-01)	100 tablet	2010-02-01	0000-00-00	No	No	Current
0115-5511-02	00115551102	500 TABLET in 1 BOTTLE (0115-5511-02)	500 tablet	2010-02-01	0000-00-00	No	No	Current
0115-5511-03	00115551103	1000 TABLET in 1 BOTTLE (0115-5511-03)	1000 tablet	2010-02-01	0000-00-00	No	No	Current
0115-5511-10	00115551110	90 TABLET in 1 BOTTLE (0115-5511-10)	90 tablet	2010-02-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fenofibrate	American Health Packaging	2023-01-27	HUMAN PRESCRIPTION DRUG LABEL	13
FENOFIBRATE	AvKARE	2022-09-02	HUMAN PRESCRIPTION DRUG LABEL	8
FENOFIBRATE	Amneal Pharmaceuticals of New York LLC \| Amneal Pharmaceuticals of New York, LLC \| Reed-Lane, Inc.	2021-04-01	HUMAN PRESCRIPTION DRUG LABEL	38
FENOFIBRATE	Bryant Ranch Prepack	2020-10-16	HUMAN PRESCRIPTION DRUG LABEL	3
FENOFIBRATE TABLET 54 mg and 160 mg	KAISER FOUNDATION HOSPITALS	2018-11-27	HUMAN PRESCRIPTION DRUG LABEL	9
FENOFIBRATE TABLETS, 54 mg and 160 mg	Aidarex Pharmaceuticals LLC	2014-01-01	HUMAN PRESCRIPTION DRUG LABEL	1
FENOFIBRATE TABLETS, 54 mg and 160 mg	Physicians Total Care, Inc.	2010-05-25	HUMAN PRESCRIPTION DRUG LABEL	2