Fenofibrate

Product NDC: 0115-1522
11-digit product format: 001151522
Labeler code: 0115
Product ID: 0115-1522_da91e90a-03ad-4068-b158-fc5c5912e8bf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fenofibrate
Dosage form: TABLET
Route: ORAL
Labeler: Amneal Pharmaceuticals of New York LLC
Application: NDA022118
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2015-06-24
Marketing end: 0000-00-00
Substance: FENOFIBRATE
Active strength: 40 mg/1
Pharmacologic classes: Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

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	0115-1522		D	Discontinued by firm		2026-08-10
excluded package	package	0115-1522	0115-1522-10	D	Discontinued by firm		2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 14 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0115-1522-10	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0115-1522-10	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0115-1522-10	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0115-1522-10	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	0115-1522-10	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	0115-1522-10	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	0115-1522-10	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

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
N022118-001	FENOGLIDE	FENOFIBRATE	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2007-08-10
N022118-002	FENOGLIDE	FENOFIBRATE	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2007-08-10

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022118-001	FENOGLIDE	40MG	TABLET / ORAL		RLD	2007-08-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022118-002	FENOGLIDE	120MG	TABLET / ORAL		RLD	2007-08-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022118-001	FENOGLIDE	40MG	TABLET / ORAL		RLD	2007-08-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022118-002	FENOGLIDE	120MG	TABLET / ORAL		RLD	2007-08-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022118-001	FENOGLIDE	40MG	TABLET / ORAL		RLD	2007-08-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022118-002	FENOGLIDE	120MG	TABLET / ORAL		RLD	2007-08-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022118-001	FENOGLIDE	40MG	TABLET / ORAL		RLD	2007-08-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022118-002	FENOGLIDE	120MG	TABLET / ORAL		RLD	2007-08-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022118-001	FENOGLIDE	40MG	TABLET / ORAL		RLD	2007-08-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022118-002	FENOGLIDE	120MG	TABLET / ORAL		RLD	2007-08-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022118-001	FENOGLIDE	40MG	TABLET / ORAL		RLD	2007-08-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022118-002	FENOGLIDE	120MG	TABLET / ORAL		RLD	2007-08-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022118-001	FENOGLIDE	40MG	TABLET / ORAL		RLD	2007-08-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022118-002	FENOGLIDE	120MG	TABLET / ORAL		RLD	2007-08-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022118-001	FENOGLIDE	40MG	TABLET / ORAL		RLD	2007-08-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022118-002	FENOGLIDE	120MG	TABLET / ORAL		RLD	2007-08-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022118-001	FENOGLIDE	40MG	TABLET / ORAL		RLD	2007-08-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022118-002	FENOGLIDE	120MG	TABLET / ORAL		RLD	2007-08-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022118-001	FENOGLIDE	40MG	TABLET / ORAL		RLD	2007-08-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022118-002	FENOGLIDE	120MG	TABLET / ORAL		RLD	2007-08-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022118-001	FENOGLIDE	40MG	TABLET / ORAL		RLD	2007-08-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022118-002	FENOGLIDE	120MG	TABLET / ORAL		RLD	2007-08-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022118-001	FENOGLIDE	40MG	TABLET / ORAL		RLD	2007-08-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022118-002	FENOGLIDE	120MG	TABLET / ORAL		RLD	2007-08-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022118-001	FENOGLIDE	40MG	TABLET / ORAL		RLD	2007-08-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022118-002	FENOGLIDE	120MG	TABLET / ORAL		RLD	2007-08-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022118-001	FENOGLIDE	40MG	TABLET / ORAL	AB	RLD	2007-08-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022118-002	FENOGLIDE	120MG	TABLET / ORAL	AB	RLD, RS	2007-08-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022118-001	FENOGLIDE	40MG	TABLET / ORAL	AB	RLD	2007-08-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022118-002	FENOGLIDE	120MG	TABLET / ORAL	AB	RLD, RS	2007-08-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022118-001	FENOGLIDE	40MG	TABLET / ORAL	AB	RLD	2007-08-10	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022118-002	FENOGLIDE	120MG	TABLET / ORAL	AB	RLD, RS	2007-08-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022118-001	FENOGLIDE	40MG	TABLET / ORAL	AB	RLD	2007-08-10	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022118-002	FENOGLIDE	120MG	TABLET / ORAL	AB	RLD, RS	2007-08-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022118-001	FENOGLIDE	40MG	TABLET / ORAL	AB	RLD	2007-08-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022118-002	FENOGLIDE	120MG	TABLET / ORAL	AB	RLD, RS	2007-08-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022118-001	FENOGLIDE	40MG	TABLET / ORAL	AB	RLD	2007-08-10	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022118-002	FENOGLIDE	120MG	TABLET / ORAL	AB	RLD, RS	2007-08-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022118-001	FENOGLIDE	40MG	TABLET / ORAL	AB	RLD	2007-08-10	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022118-002	FENOGLIDE	120MG	TABLET / ORAL	AB	RLD, RS	2007-08-10	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-05-31 18:47 UTC	2024-05	N022118-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022118-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022118-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022118-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022118-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022118-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022118-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022118-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022118-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022118-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022118-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022118-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022118-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022118-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022118-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022118-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022118-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022118-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022118-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022118-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022118-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022118-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022118-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022118-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022118-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022118-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022118-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022118-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022118-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022118-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022118-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N022118-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022118-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N022118-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022118-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022118-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022118-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022118-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022118-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022118-002	AB	1	`a67488948f0b…`

Observed Orange Book patent history#

Patent history page 1 of 7 · 280 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022118-001	8124125	2024-10-01	U-1234	Drug product	2012-03-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022118-001	8481078	2024-10-01	U-1416	Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022118-001	9173847	2024-10-01		Drug product	2015-11-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022118-001	7658944	2024-12-09		Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022118-002	8124125	2024-10-01	U-1234	Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022118-002	8481078	2024-10-01	U-1416	Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022118-002	9173847	2024-10-01		Drug product	2015-11-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022118-002	7658944	2024-12-09		Drug product		`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022118-001	8124125	2024-10-01	U-1234	Drug product	2012-03-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022118-001	8481078	2024-10-01	U-1416	Drug product		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022118-001	9173847	2024-10-01		Drug product	2015-11-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022118-001	7658944	2024-12-09		Drug product		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022118-002	8124125	2024-10-01	U-1234	Drug product		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022118-002	8481078	2024-10-01	U-1416	Drug product		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022118-002	9173847	2024-10-01		Drug product	2015-11-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022118-002	7658944	2024-12-09		Drug product		`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022118-001	8124125	2024-10-01	U-1234	Drug product	2012-03-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022118-001	8481078	2024-10-01	U-1416	Drug product		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022118-001	9173847	2024-10-01		Drug product	2015-11-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022118-001	7658944	2024-12-09		Drug product		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022118-002	8124125	2024-10-01	U-1234	Drug product		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022118-002	8481078	2024-10-01	U-1416	Drug product		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022118-002	9173847	2024-10-01		Drug product	2015-11-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022118-002	7658944	2024-12-09		Drug product		`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022118-001	8124125	2024-10-01	U-1234	Drug product	2012-03-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022118-001	8481078	2024-10-01	U-1416	Drug product		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022118-001	9173847	2024-10-01		Drug product	2015-11-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022118-001	7658944	2024-12-09		Drug product		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022118-002	8124125	2024-10-01	U-1234	Drug product		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022118-002	8481078	2024-10-01	U-1416	Drug product		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022118-002	9173847	2024-10-01		Drug product	2015-11-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022118-002	7658944	2024-12-09		Drug product		`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022118-001	8124125	2024-10-01	U-1234	Drug product	2012-03-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022118-001	8481078	2024-10-01	U-1416	Drug product		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022118-001	9173847	2024-10-01		Drug product	2015-11-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022118-001	7658944	2024-12-09		Drug product		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022118-002	8124125	2024-10-01	U-1234	Drug product		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022118-002	8481078	2024-10-01	U-1416	Drug product		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022118-002	9173847	2024-10-01		Drug product	2015-11-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022118-002	7658944	2024-12-09		Drug product		`d06236e962d9…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0115-1522-10	2024-11-18	C162847	48780-1	f386c649-e402-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use FENOFIBRATE TABLETS safely and effectively. See full prescribing information for FENOFIBRATE TABLETS. FENOFIBRATE tablets, for oral use Initial U.S. Approval: 1993
0115-1522-10	2023-01-30	C162847	48780-1	f386c649-e402-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use FENOFIBRATE TABLETS safely and effectively. See full prescribing information for FENOFIBRATE TABLETS. FENOFIBRATE tablets, for oral use Initial U.S. Approval: 1993

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0115-1522-10	EA - Each	0115-1522	88ee9181-da1e-4e98-9265-82e43f4b4294	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Fenofibrate	ACTIVE INGREDIENT	U202363UOS	FENOFIBRATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]	1
Fenofibrate	ACTIVE MOIETY	U202363UOS	FENOFIBRATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]	1
Lactose Monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	FENOFIBRATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]	1
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	FENOFIBRATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]	1
Poloxamer 188	INACTIVE INGREDIENT	LQA7B6G8JG	FENOFIBRATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]	1
Polyethylene Glycol 6000	INACTIVE INGREDIENT	30IQX730WE	FENOFIBRATE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0115-1522	FENOFIBRATE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]	14	Legacy NDC	20241120_0c3a6ac7-aefa-4b10-88aa-01b702a4fe89.zip

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	Marketing end	Sample	Exclude flag	Status
0115-1522-10	00115152210	90 TABLET in 1 BOTTLE (0115-1522-10)	90 tablet	2015-06-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fenofibrate	Amneal Pharmaceuticals of New York LLC \| Catalent Pharma Solutions, LLC	2024-11-18	HUMAN PRESCRIPTION DRUG LABEL	14