Fenofibrate

Product NDC: 70518-4721
Requested package NDC: 70518-4721-0
11-digit product format: 705184721
Labeler code: 70518
Product ID: 70518-4721_583eb9d0-fc65-53e8-e063-6294a90ae0fc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fenofibrate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA216798
Marketing category: ANDA
Marketing start: 2026-08-04
Substance: FENOFIBRATE
Active strength: 54 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 · 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: 2027-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
b6b5d74d-d418-4ada-8ccd-592b0f57b2ff	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 · 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 ndc (package): 70518-4721-0 ndc (product): 70518-4721 ndc11 (package): 70518472100
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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
70518-4721-0	70518472100	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4721-0)	2026-08-04	No	No	Current