Fenofibric Acid

Product NDC: 0115-1324
11-digit product format: 001151324
Labeler code: 0115
Product ID: 0115-1324_a1c48695-091f-4924-acf4-a420be16939d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: FENOFIBRIC ACID
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Amneal Pharmaceuticals of New York LLC
Application: ANDA200264
Marketing category: ANDA
Marketing start: 2024-06-01
Substance: FENOFIBRIC ACID
Active strength: 45 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
A200264-001	FENOFIBRIC ACID	CHOLINE FENOFIBRATE	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB		2016-09-07
A200264-002	FENOFIBRIC ACID	CHOLINE FENOFIBRATE	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB		2016-09-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A200264-001	AB
A200264-002	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 3 · 82 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
2026-02-19 14:30 UTC	2026-02	A200264-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200264-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-09-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200264-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-09-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200264-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-09-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200264-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-09-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200264-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-09-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200264-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-09-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200264-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-09-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200264-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-09-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200264-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-09-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200264-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-09-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200264-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-09-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200264-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-09-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200264-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-09-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200264-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-09-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200264-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-09-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200264-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-09-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200264-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-09-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200264-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-09-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200264-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-09-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200264-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-09-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200264-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-09-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200264-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-09-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200264-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-09-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200264-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-09-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200264-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-09-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200264-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-09-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200264-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-09-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200264-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-09-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200264-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-09-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200264-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-09-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200264-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-09-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200264-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-09-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200264-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-09-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200264-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-09-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200264-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-09-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200264-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-09-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A200264-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-09-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200264-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-09-07	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A200264-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2016-09-07	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A200264-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200264-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200264-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200264-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200264-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200264-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200264-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200264-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200264-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200264-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200264-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200264-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200264-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200264-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200264-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200264-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200264-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200264-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200264-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200264-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200264-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200264-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200264-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200264-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200264-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200264-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200264-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200264-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200264-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200264-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200264-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200264-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200264-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200264-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200264-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200264-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200264-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A200264-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200264-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A200264-002	AB	1	`782e0a99824c…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FENOFIBRIC ACID	45 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
BGF9MN2HU1	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
828373	Internal RxNorm lookup
828379	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
e73404c5-e0ee-48e9-8b09-7a00d7e18e6c	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0115-1324-10	Fenofibric Acid	90 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	90		9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0115-1324	FENOFIBRIC ACID CAPSULE, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]	7	Current NDC, 1 package rows	20240606_e73404c5-e0ee-48e9-8b09-7a00d7e18e6c.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fenofibric Acid	FENOFIBRIC ACID	Amneal Pharmaceuticals of New York LLC	e73404c5-e0ee-48e9-8b09-7a00d7e18e6c	2025-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200264 application number: ANDA200264 ndc (product): 0115-1324

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
BGF9MN2HU1	FENOFIBRIC ACID	42017-89-0	FENOFIBRIC ACID

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
828373	fenofibric acid 135 MG Delayed Release Oral Capsule	PSN	e73404c5-e0ee-48e9-8b09-7a00d7e18e6c	9
828379	fenofibric acid 45 MG Delayed Release Oral Capsule	PSN	e73404c5-e0ee-48e9-8b09-7a00d7e18e6c	9
828373	fenofibric acid 135 MG Delayed Release Oral Capsule	SCD	e73404c5-e0ee-48e9-8b09-7a00d7e18e6c	9
828379	fenofibric acid 45 MG Delayed Release Oral Capsule	SCD	e73404c5-e0ee-48e9-8b09-7a00d7e18e6c	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
0115-1324-10	00115132410	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0115-1324-10)	2024-06-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fenofibric Acid	Amneal Pharmaceuticals of New York LLC \| Amneal Pharmaceuticals Private Limited	2025-06-23	HUMAN PRESCRIPTION DRUG LABEL	9