Fenofibrate

Product NDC: 50090-7209
11-digit product format: 500907209
Labeler code: 50090
Product ID: 50090-7209_2aae8e1f-04c2-46dd-9c83-8effb5193571
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fenofibrate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA216798
Marketing category: ANDA
Marketing start: 2022-09-27
Substance: FENOFIBRATE
Active strength: 160 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 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
A216798-001	FENOFIBRATE	FENOFIBRATE	54MG	TABLET / ORAL	AB		2022-09-27
A216798-002	FENOFIBRATE	FENOFIBRATE	160MG	TABLET / ORAL	AB		2022-09-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216798-001	AB
A216798-002	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 2 · 56 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	A216798-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2022-09-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216798-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2022-09-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216798-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2022-09-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216798-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2022-09-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216798-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2022-09-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216798-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2022-09-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216798-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2022-09-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216798-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2022-09-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216798-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2022-09-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216798-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2022-09-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216798-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2022-09-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216798-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2022-09-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216798-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2022-09-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216798-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2022-09-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216798-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2022-09-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216798-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2022-09-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216798-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2022-09-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216798-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2022-09-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216798-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2022-09-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216798-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2022-09-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216798-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2022-09-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216798-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2022-09-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216798-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2022-09-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216798-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2022-09-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216798-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2022-09-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216798-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2022-09-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216798-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2022-09-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216798-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2022-09-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216798-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2022-09-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216798-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2022-09-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216798-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2022-09-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A216798-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2022-09-27	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216798-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2022-09-27	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216798-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2022-09-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216798-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2022-09-27	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A216798-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2022-09-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216798-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2022-09-27	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A216798-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2022-09-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216798-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2022-09-27	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216798-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2022-09-27	`a72a2bbeb626…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 56 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A216798-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216798-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216798-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216798-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216798-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216798-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216798-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216798-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216798-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216798-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216798-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216798-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216798-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216798-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216798-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216798-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216798-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216798-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216798-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216798-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216798-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216798-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216798-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216798-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216798-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216798-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216798-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216798-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216798-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216798-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216798-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A216798-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216798-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216798-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216798-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A216798-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216798-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A216798-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216798-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216798-002	AB	1	`a72a2bbeb626…`

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: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FENOFIBRATE	160 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
349287	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
db3ac584-2c8e-4f69-b24c-96ddcca2c23f	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
50090-7209-0	Fenofibrate	90 in 1 BOTTLE	TABLET, FILM COATED	90		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-7209-0	EA - Each	50090-7209	dfac4e9d-2f89-4158-b2b5-44254f54f4b4	1	2024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-7209	FENOFIBRATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]	2	Current NDC, 1 package rows	20240808_db3ac584-2c8e-4f69-b24c-96ddcca2c23f.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	REMEDYREPACK INC.	b6b5d74d-d418-4ada-8ccd-592b0f57b2ff	2026-08-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216798 application number: ANDA216798
Fenofibrate	FENOFIBRATE	Bryant Ranch Prepack	bbeae8e4-e06a-4c19-a1b9-f6143306dab9	2026-02-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216798 application number: ANDA216798
Fenofibrate	FENOFIBRATE	A-S Medication Solutions	db3ac584-2c8e-4f69-b24c-96ddcca2c23f	2025-10-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216798 application number: ANDA216798 ndc (product): 50090-7209
Fenofibrate	FENOFIBRATE	A-S Medication Solutions	d26e21bf-6c54-437d-81fe-07220e450561	2025-10-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216798 application number: ANDA216798
Fenofibrate	FENOFIBRATE	A-S Medication Solutions	556c4800-24f6-4237-8636-3211997cbb03	2025-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216798 application number: ANDA216798
Fenofibrate	FENOFIBRATE	Preferred Pharmaceuticals Inc.	7792d680-76ee-4146-9451-b16c40656cc1	2025-04-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216798 application number: ANDA216798
Fenofibrate	FENOFIBRATE	Aurobindo Pharma Limited	a7cfa38f-b4db-40d3-8821-3f7c85e2727e	2025-02-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216798 application number: ANDA216798
Fenofibrate	FENOFIBRATE	NuCare Pharmaceuticals,Inc.	0b4e90dd-646b-afec-e063-6294a90a598e	2025-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216798 application number: ANDA216798

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	db3ac584-2c8e-4f69-b24c-96ddcca2c23f	4
349287	fenofibrate 160 MG Oral Tablet	SCD	db3ac584-2c8e-4f69-b24c-96ddcca2c23f	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
50090-7209-0	50090720900	90 TABLET, FILM COATED in 1 BOTTLE (50090-7209-0)	2024-08-05	No	No	Current