Fenofibric Acid

Product NDC: 0115-1555
11-digit product format: 001151555
Labeler code: 0115
Product ID: 0115-1555_72e2c9bb-63d6-4a3b-bee1-52a18e95bf0a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fenofibric Acid
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Amneal Pharmaceuticals of New York LLC
Application: NDA022224
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2016-09-12
Marketing end: 2026-07-31
Substance: FENOFIBRIC ACID
Active strength: 135 mg/1
Pharmacologic classes: Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag: No
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0115-1555		D	Discontinued by firm		2026-08-17
excluded package	package	0115-1555	0115-1555-10	D	Discontinued by firm		2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N022224-001	TRILIPIX	CHOLINE FENOFIBRATE	EQ 45MG FENOFIBRIC ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED RELEASE / ORAL		RLD	2008-12-15
N022224-002	TRILIPIX	CHOLINE FENOFIBRATE	EQ 135MG FENOFIBRIC ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED RELEASE / ORAL		RLD	2008-12-15

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 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022224-001	TRILIPIX	EQ 45MG FENOFIBRIC ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED RELEASE / ORAL		RLD	2008-12-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022224-002	TRILIPIX	EQ 135MG FENOFIBRIC ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, DELAYED RELEASE / ORAL		RLD	2008-12-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022224-001	TRILIPIX	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL		RLD	2008-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022224-002	TRILIPIX	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL		RLD	2008-12-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022224-001	TRILIPIX	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL		RLD	2008-12-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022224-002	TRILIPIX	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL		RLD	2008-12-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022224-001	TRILIPIX	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL		RLD	2008-12-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022224-002	TRILIPIX	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL		RLD	2008-12-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022224-001	TRILIPIX	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2008-12-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022224-002	TRILIPIX	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2008-12-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022224-001	TRILIPIX	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2008-12-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022224-002	TRILIPIX	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2008-12-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022224-001	TRILIPIX	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2008-12-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022224-002	TRILIPIX	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2008-12-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022224-001	TRILIPIX	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2008-12-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022224-002	TRILIPIX	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2008-12-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022224-001	TRILIPIX	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2008-12-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022224-002	TRILIPIX	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2008-12-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022224-001	TRILIPIX	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2008-12-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022224-002	TRILIPIX	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2008-12-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022224-001	TRILIPIX	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2008-12-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022224-002	TRILIPIX	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2008-12-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022224-001	TRILIPIX	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2008-12-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022224-002	TRILIPIX	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2008-12-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022224-001	TRILIPIX	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2008-12-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022224-002	TRILIPIX	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2008-12-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022224-001	TRILIPIX	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2008-12-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022224-002	TRILIPIX	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2008-12-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022224-001	TRILIPIX	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2008-12-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022224-002	TRILIPIX	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2008-12-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022224-001	TRILIPIX	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2008-12-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022224-002	TRILIPIX	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2008-12-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022224-001	TRILIPIX	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2008-12-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022224-002	TRILIPIX	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2008-12-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022224-001	TRILIPIX	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2008-12-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022224-002	TRILIPIX	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2008-12-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022224-001	TRILIPIX	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2008-12-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022224-002	TRILIPIX	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2008-12-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022224-001	TRILIPIX	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD	2008-12-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022224-002	TRILIPIX	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	RLD, RS	2008-12-15	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022224-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022224-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022224-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022224-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022224-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022224-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022224-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022224-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022224-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022224-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022224-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022224-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022224-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022224-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022224-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022224-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022224-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022224-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022224-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022224-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022224-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022224-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022224-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022224-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022224-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022224-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022224-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022224-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022224-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022224-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022224-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022224-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022224-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022224-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022224-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022224-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022224-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022224-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022224-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022224-002	AB	1	`8869cabd3fbd…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022224-001	7259186	2025-01-07	Drug substance	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022224-002	7259186	2025-01-07	Drug substance	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022224-001	7259186	2025-01-07	Drug substance	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022224-002	7259186	2025-01-07	Drug substance	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022224-001	7259186	2025-01-07	Drug substance	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022224-002	7259186	2025-01-07	Drug substance	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022224-001	7259186	2025-01-07	Drug substance	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022224-002	7259186	2025-01-07	Drug substance	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022224-001	7259186	2025-01-07	Drug substance	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022224-002	7259186	2025-01-07	Drug substance	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022224-001	7259186	2025-01-07	Drug substance	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022224-002	7259186	2025-01-07	Drug substance	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022224-001	7259186	2025-01-07	Drug substance	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022224-002	7259186	2025-01-07	Drug substance	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022224-001	7259186	2025-01-07	Drug substance	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022224-002	7259186	2025-01-07	Drug substance	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022224-001	7259186	2025-01-07	Drug substance	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022224-002	7259186	2025-01-07	Drug substance	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022224-001	7259186	2025-01-07	Drug substance	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022224-002	7259186	2025-01-07	Drug substance	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022224-001	7259186	2025-01-07	Drug substance	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022224-002	7259186	2025-01-07	Drug substance	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022224-001	7259186	2025-01-07	Drug substance	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022224-002	7259186	2025-01-07	Drug substance	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022224-001	7259186	2025-01-07	Drug substance	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022224-002	7259186	2025-01-07	Drug substance	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022224-001	7259186	2025-01-07	Drug substance	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022224-002	7259186	2025-01-07	Drug substance	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022224-001	7259186	2025-01-07	Drug substance	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022224-002	7259186	2025-01-07	Drug substance	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022224-001	7259186	2025-01-07	Drug substance	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022224-002	7259186	2025-01-07	Drug substance	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022224-001	7259186	2025-01-07	Drug substance	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022224-002	7259186	2025-01-07	Drug substance	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022224-001	7259186	2025-01-07	Drug substance	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022224-002	7259186	2025-01-07	Drug substance	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022224-001	7259186	2025-01-07	Drug substance	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022224-002	7259186	2025-01-07	Drug substance	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022224-001	7259186	2025-01-07	Drug substance	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022224-002	7259186	2025-01-07	Drug substance	`87673890dc5c…`

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
0115-1555-10	Fenofibric Acid	90 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	90		89

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0115-1555-10	EA - Each	0115-1555	e191206b-60c1-4ecf-ae82-a9a091048d12	1	2017-09-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
FENOFIBRIC ACID	ACTIVE INGREDIENT	BGF9MN2HU1	FENOFIBRIC ACID CAPSULE, DELAYED RELEASE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]	31
FENOFIBRIC ACID	ACTIVE MOIETY	BGF9MN2HU1	FENOFIBRIC ACID CAPSULE, DELAYED RELEASE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]	31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0115-1555	FENOFIBRIC ACID CAPSULE, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]	88	Current NDC, Legacy NDC, 1 package rows	20241206_369b3e55-2c05-d879-fe7e-91296c529ae9.zip

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	369b3e55-2c05-d879-fe7e-91296c529ae9	89
828379	fenofibric acid 45 MG Delayed Release Oral Capsule	PSN	369b3e55-2c05-d879-fe7e-91296c529ae9	89
828373	fenofibric acid 135 MG Delayed Release Oral Capsule	SCD	369b3e55-2c05-d879-fe7e-91296c529ae9	89
828379	fenofibric acid 45 MG Delayed Release Oral Capsule	SCD	369b3e55-2c05-d879-fe7e-91296c529ae9	89
828373	fenofibric acid 135 MG Delayed Release Oral Capsule	PSN	e3ad559c-b107-409f-a297-a052765b71ab	4
828373	fenofibric acid 135 MG Delayed Release Oral Capsule	SCD	e3ad559c-b107-409f-a297-a052765b71ab	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0115-1555-10	00115155510	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0115-1555-10)	2016-09-12	2026-07-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fenofibric Acid	Amneal Pharmaceuticals of New York LLC	2025-09-01	HUMAN PRESCRIPTION DRUG LABEL	89
Fenofibric Acid	A-S Medication Solutions	2021-04-15	HUMAN PRESCRIPTION DRUG LABEL	4