Fenofibrate

Product NDC: 50090-7994
Requested package NDC: 50090-7994-0
11-digit product format: 500907994
Labeler code: 50090
Product ID: 50090-7994_f908c2f9-ddb7-44f4-b521-ed91ff75cb5b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fenofibrate
Dosage form: CAPSULE
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA213842
Marketing category: ANDA
Marketing start: 2020-10-22
Substance: FENOFIBRATE
Active strength: 200 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A213842-001	FENOFIBRATE (MICRONIZED)	FENOFIBRATE	67MG	CAPSULE / ORAL	AB	2020-10-19
A213842-002	FENOFIBRATE (MICRONIZED)	FENOFIBRATE	134MG	CAPSULE / ORAL	AB	2020-10-19
A213842-003	FENOFIBRATE (MICRONIZED)	FENOFIBRATE	200MG	CAPSULE / ORAL	AB	2020-10-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A213842-001	AB
A213842-002	AB
A213842-003	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 · 114 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	A213842-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2020-10-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213842-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2020-10-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213842-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2020-10-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213842-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2020-10-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213842-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2020-10-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213842-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2020-10-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213842-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2020-10-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213842-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2020-10-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213842-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2020-10-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213842-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2020-10-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213842-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2020-10-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213842-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2020-10-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213842-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2020-10-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213842-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2020-10-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213842-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2020-10-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213842-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2020-10-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213842-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2020-10-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213842-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2020-10-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213842-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2020-10-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213842-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2020-10-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213842-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2020-10-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213842-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2020-10-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213842-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2020-10-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213842-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2020-10-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213842-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2020-10-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213842-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2020-10-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213842-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2020-10-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213842-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2020-10-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213842-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2020-10-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213842-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2020-10-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213842-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2020-10-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213842-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2020-10-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213842-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2020-10-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213842-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2020-10-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213842-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2020-10-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213842-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2020-10-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213842-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2020-10-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213842-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2020-10-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213842-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2020-10-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213842-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2020-10-19	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 114 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	A213842-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213842-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213842-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213842-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213842-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213842-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213842-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213842-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213842-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213842-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213842-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213842-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213842-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213842-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213842-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213842-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213842-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213842-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213842-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213842-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213842-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213842-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213842-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213842-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213842-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213842-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213842-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213842-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213842-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213842-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213842-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213842-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213842-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213842-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213842-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213842-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213842-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213842-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213842-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213842-001	AB	1	`301d65b070ca…`

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	200 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
310289	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
ce403472-6c0c-4854-bb82-ba6539e1ae07	Available on FDA.report

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fenofibrate	FENOFIBRATE	A-S Medication Solutions	ce403472-6c0c-4854-bb82-ba6539e1ae07	2026-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213842 application number: ANDA213842 ndc (package): 50090-7994-0 ndc (product): 50090-7994 ndc11 (package): 50090799400
Fenofibrate	FENOFIBRATE	Alembic Pharmaceuticals Limited	954753e7-c8d4-487c-b2ad-f90dfb758a92	2023-01-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213842 application number: ANDA213842
Fenofibrate	FENOFIBRATE	Alembic Pharmaceuticals Inc.	d5c046b5-c3fd-4ef3-8245-c93796d4d880	2022-05-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213842 application number: ANDA213842

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
U202363UOS	FENOFIBRATE	49562-28-9	FENOFIBRATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
50090-7994-0	50090799400	90 CAPSULE in 1 BOTTLE (50090-7994-0)	90 capsule	2026-06-09	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
FENOFIBRATE CAPSULES USP, (MICRONIZED) Rx only	A-S Medication Solutions	2026-06-10	Human Prescription Drug Label	1