Fenofibrate

Product NDC: 43975-305
11-digit product format: 439750305
Labeler code: 43975
Product ID: 43975-305_379ca6d7-14ee-4c36-a271-325d231a2fba
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fenofibrate
Dosage form: CAPSULE
Route: ORAL
Labeler: ANI Pharmaceuticals, Inc.
Application: ANDA209504
Marketing category: ANDA
Marketing start: 2018-05-01
Substance: FENOFIBRATE
Active strength: 134 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 42.

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
A209504-001	FENOFIBRATE (MICRONIZED)	FENOFIBRATE	67MG	CAPSULE / ORAL	AB	2018-04-30
A209504-002	FENOFIBRATE (MICRONIZED)	FENOFIBRATE	134MG	CAPSULE / ORAL	AB	2018-04-30
A209504-003	FENOFIBRATE (MICRONIZED)	FENOFIBRATE	200MG	CAPSULE / ORAL	AB	2018-04-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209504-001	AB
A209504-002	AB
A209504-003	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 4 · 126 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
2026-08-18 06:07:40	2026-07	A209504-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2018-04-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209504-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2018-04-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209504-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2018-04-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209504-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2018-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209504-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2018-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209504-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2018-04-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209504-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2018-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209504-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2018-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209504-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2018-04-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209504-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2018-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209504-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2018-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209504-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2018-04-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209504-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2018-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209504-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2018-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209504-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2018-04-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209504-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2018-04-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209504-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2018-04-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209504-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2018-04-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209504-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2018-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209504-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2018-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209504-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2018-04-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209504-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2018-04-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209504-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2018-04-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209504-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2018-04-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209504-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2018-04-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209504-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2018-04-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209504-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2018-04-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209504-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2018-04-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209504-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2018-04-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209504-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2018-04-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209504-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2018-04-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209504-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2018-04-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209504-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2018-04-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209504-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2018-04-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209504-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2018-04-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209504-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2018-04-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209504-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2018-04-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209504-002	FENOFIBRATE (MICRONIZED)	134MG	CAPSULE / ORAL	AB	2018-04-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209504-003	FENOFIBRATE (MICRONIZED)	200MG	CAPSULE / ORAL	AB	2018-04-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209504-001	FENOFIBRATE (MICRONIZED)	67MG	CAPSULE / ORAL	AB	2018-04-30	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A209504-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209504-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209504-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209504-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209504-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209504-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209504-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209504-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209504-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209504-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209504-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209504-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209504-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209504-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209504-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209504-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209504-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209504-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209504-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209504-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209504-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209504-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209504-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209504-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209504-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209504-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209504-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209504-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209504-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209504-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209504-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209504-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209504-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209504-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209504-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209504-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209504-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209504-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209504-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209504-001	AB	1	`1e350fbaab3a…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FENOFIBRATE	134 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
200311	Internal RxNorm lookup
310288	Internal RxNorm lookup
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
c740f57c-cac5-4526-a5a9-aaab65b1caf6	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
43975-305-10	Fenofibrate	100 in 1 BOTTLE	CAPSULE	100		7
43975-305-50	Fenofibrate	500 in 1 BOTTLE	CAPSULE	500		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43975-305-10	EA - Each	43975-305	e7296b0f-5f04-4732-9d3b-aaffd1457833	1	2018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43975-305	FENOFIBRATE CAPSULE [ANI PHARMACEUTICALS, INC.]	6	Current NDC, Legacy NDC, 2 package rows	20220922_c740f57c-cac5-4526-a5a9-aaab65b1caf6.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	ANI Pharmaceuticals, Inc.	c740f57c-cac5-4526-a5a9-aaab65b1caf6	2025-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209504 application number: ANDA209504 ndc (product): 43975-305
Fenofibrate	FENOFIBRATE	Coupler LLC	3134b274-5dc0-cf90-e063-6294a90a252b	2025-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209504 application number: ANDA209504

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
310288	fenofibrate 134 MG Oral Capsule	PSN	c740f57c-cac5-4526-a5a9-aaab65b1caf6	7
310289	fenofibrate 200 MG Oral Capsule	PSN	c740f57c-cac5-4526-a5a9-aaab65b1caf6	7
200311	fenofibrate 67 MG Oral Capsule	PSN	c740f57c-cac5-4526-a5a9-aaab65b1caf6	7
310288	fenofibrate 134 MG Oral Capsule	SCD	c740f57c-cac5-4526-a5a9-aaab65b1caf6	7
310289	fenofibrate 200 MG Oral Capsule	SCD	c740f57c-cac5-4526-a5a9-aaab65b1caf6	7
200311	fenofibrate 67 MG Oral Capsule	SCD	c740f57c-cac5-4526-a5a9-aaab65b1caf6	7
310288	fenofibrate 134 MG Oral Capsule	PSN	e64e125f-2b59-cb97-e053-2995a90a63f6	1
310288	fenofibrate 134 MG Oral Capsule	SCD	e64e125f-2b59-cb97-e053-2995a90a63f6	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43975-305-10	43975030510	100 CAPSULE in 1 BOTTLE (43975-305-10)	100 capsule	2018-05-01	0000-00-00	No	No	Current
43975-305-50	43975030550	500 CAPSULE in 1 BOTTLE (43975-305-50)	500 capsule	2018-05-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fenofibrate Capsules USP	ANI Pharmaceuticals, Inc.	2025-07-28	HUMAN PRESCRIPTION DRUG LABEL	7
Fenofibrate Capsules USP	NuCare Pharmaceuticals,Inc.	2022-08-15	HUMAN PRESCRIPTION DRUG LABEL	1