Fenofibrate

Product NDC: 46708-350
11-digit product format: 467080350
Labeler code: 46708
Product ID: 46708-350_8250e3fe-6420-401e-af14-45662b8a7b48
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fenofibrate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Alembic Pharmaceuticals Limited
Application: ANDA213252
Marketing category: ANDA
Marketing start: 2020-01-23
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
A213252-001	FENOFIBRATE	FENOFIBRATE	54MG	TABLET / ORAL			2020-01-17
A213252-002	FENOFIBRATE	FENOFIBRATE	160MG	TABLET / ORAL			2020-01-17

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 · 74 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A213252-001	FENOFIBRATE	54MG	TABLET / ORAL	2020-01-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213252-002	FENOFIBRATE	160MG	TABLET / ORAL	2020-01-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213252-001	FENOFIBRATE	54MG	TABLET / ORAL	2020-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213252-002	FENOFIBRATE	160MG	TABLET / ORAL	2020-01-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213252-001	FENOFIBRATE	54MG	TABLET / ORAL	2020-01-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213252-002	FENOFIBRATE	160MG	TABLET / ORAL	2020-01-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213252-001	FENOFIBRATE	54MG	TABLET / ORAL	2020-01-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213252-002	FENOFIBRATE	160MG	TABLET / ORAL	2020-01-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213252-001	FENOFIBRATE	54MG	TABLET / ORAL	2020-01-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213252-002	FENOFIBRATE	160MG	TABLET / ORAL	2020-01-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213252-001	FENOFIBRATE	54MG	TABLET / ORAL	2020-01-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213252-002	FENOFIBRATE	160MG	TABLET / ORAL	2020-01-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213252-001	FENOFIBRATE	54MG	TABLET / ORAL	2020-01-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213252-002	FENOFIBRATE	160MG	TABLET / ORAL	2020-01-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213252-001	FENOFIBRATE	54MG	TABLET / ORAL	2020-01-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213252-002	FENOFIBRATE	160MG	TABLET / ORAL	2020-01-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213252-001	FENOFIBRATE	54MG	TABLET / ORAL	2020-01-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213252-002	FENOFIBRATE	160MG	TABLET / ORAL	2020-01-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213252-001	FENOFIBRATE	54MG	TABLET / ORAL	2020-01-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213252-002	FENOFIBRATE	160MG	TABLET / ORAL	2020-01-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213252-001	FENOFIBRATE	54MG	TABLET / ORAL	2020-01-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213252-002	FENOFIBRATE	160MG	TABLET / ORAL	2020-01-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213252-001	FENOFIBRATE	54MG	TABLET / ORAL	2020-01-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213252-002	FENOFIBRATE	160MG	TABLET / ORAL	2020-01-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213252-001	FENOFIBRATE	54MG	TABLET / ORAL	2020-01-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213252-002	FENOFIBRATE	160MG	TABLET / ORAL	2020-01-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213252-001	FENOFIBRATE	54MG	TABLET / ORAL	2020-01-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213252-002	FENOFIBRATE	160MG	TABLET / ORAL	2020-01-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213252-001	FENOFIBRATE	54MG	TABLET / ORAL	2020-01-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213252-002	FENOFIBRATE	160MG	TABLET / ORAL	2020-01-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213252-001	FENOFIBRATE	54MG	TABLET / ORAL	2020-01-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213252-002	FENOFIBRATE	160MG	TABLET / ORAL	2020-01-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213252-001	FENOFIBRATE	54MG	TABLET / ORAL	2020-01-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213252-002	FENOFIBRATE	160MG	TABLET / ORAL	2020-01-17	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213252-001	FENOFIBRATE	54MG	TABLET / ORAL	2020-01-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213252-002	FENOFIBRATE	160MG	TABLET / ORAL	2020-01-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213252-001	FENOFIBRATE	54MG	TABLET / ORAL	2020-01-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213252-002	FENOFIBRATE	160MG	TABLET / ORAL	2020-01-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213252-001	FENOFIBRATE	54MG	TABLET / ORAL	2020-01-17	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213252-002	FENOFIBRATE	160MG	TABLET / ORAL	2020-01-17	`87673890dc5c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2020-11-12 02:37 UTC	2020-11	A213252-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A213252-002	AB	1	`c0c555d07b60…`

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
65ca643c-3b31-4e53-bc06-0e11418baf7d	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
46708-350-30	2023-02-01	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
46708-350-71	2023-02-01	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
46708-350-90	2023-02-01	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
46708-350-30	2023-01-30	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
46708-350-71	2023-01-30	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
46708-350-90	2023-01-30	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
46708-350-30	Fenofibrate	30 in 1 BOTTLE	TABLET, FILM COATED	30	2
46708-350-71	Fenofibrate	500 in 1 BOTTLE	TABLET, FILM COATED	500	2
46708-350-90	Fenofibrate	90 in 1 BOTTLE	TABLET, FILM COATED	90	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
46708-350	FENOFIBRATE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED]	2	Current NDC, Legacy NDC, 3 package rows	20230202_65ca643c-3b31-4e53-bc06-0e11418baf7d.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	Alembic Pharmaceuticals Limited	65ca643c-3b31-4e53-bc06-0e11418baf7d	2023-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213252 application number: ANDA213252 ndc (product): 46708-350
Fenofibrate	FENOFIBRATE	Alembic Pharmaceuticals Inc.	1e56492f-e2b1-4a07-b697-b59b3a0ac05e	2021-02-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213252 application number: ANDA213252

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	65ca643c-3b31-4e53-bc06-0e11418baf7d	2
351133	fenofibrate 54 MG Oral Tablet	PSN	65ca643c-3b31-4e53-bc06-0e11418baf7d	2
349287	fenofibrate 160 MG Oral Tablet	SCD	65ca643c-3b31-4e53-bc06-0e11418baf7d	2
351133	fenofibrate 54 MG Oral Tablet	SCD	65ca643c-3b31-4e53-bc06-0e11418baf7d	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
46708-350-30	46708035030	30 TABLET, FILM COATED in 1 BOTTLE (46708-350-30)	2020-01-23	0000-00-00	No	No	Current
46708-350-71	46708035071	500 TABLET, FILM COATED in 1 BOTTLE (46708-350-71)	2020-01-23	0000-00-00	No	No	Current
46708-350-90	46708035090	90 TABLET, FILM COATED in 1 BOTTLE (46708-350-90)	2020-01-23	0000-00-00	No	No	Current