Fenofibrate

Product NDC: 68382-269
11-digit product format: 683820269
Labeler code: 68382
Product ID: 68382-269_ed00bf28-39be-4b5a-a500-33962219771b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fenofibrate
Dosage form: TABLET
Route: ORAL
Labeler: Zydus Pharmaceuticals USA Inc
Application: NDA021656
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2016-02-09
Marketing end: 0000-00-00
Substance: FENOFIBRATE
Active strength: 48 mg/1
Pharmacologic classes: Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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	68382-269		D	Discontinued by firm		2026-08-10
excluded package	package	68382-269	68382-269-16	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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68382-269-16	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68382-269-16	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68382-269-16	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68382-269-16	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68382-269-16	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68382-269-16	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68382-269-16	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68382-269-16	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68382-269-16	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68382-269-16	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68382-269-16	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68382-269-16	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
N021656-001	TRICOR	FENOFIBRATE	48MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2004-11-05
N021656-002	TRICOR	FENOFIBRATE	145MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2004-11-05

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	N021656-001	TRICOR	48MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2004-11-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021656-002	TRICOR	145MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2004-11-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021656-001	TRICOR	48MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2004-11-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021656-002	TRICOR	145MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2004-11-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021656-001	TRICOR	48MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2004-11-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021656-002	TRICOR	145MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2004-11-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021656-001	TRICOR	48MG	TABLET / ORAL		RLD	2004-11-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021656-002	TRICOR	145MG	TABLET / ORAL		RLD	2004-11-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021656-001	TRICOR	48MG	TABLET / ORAL		RLD	2004-11-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021656-002	TRICOR	145MG	TABLET / ORAL		RLD	2004-11-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021656-001	TRICOR	48MG	TABLET / ORAL		RLD	2004-11-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021656-002	TRICOR	145MG	TABLET / ORAL		RLD	2004-11-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021656-001	TRICOR	48MG	TABLET / ORAL		RLD	2004-11-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021656-002	TRICOR	145MG	TABLET / ORAL		RLD	2004-11-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021656-001	TRICOR	48MG	TABLET / ORAL		RLD	2004-11-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021656-002	TRICOR	145MG	TABLET / ORAL		RLD	2004-11-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021656-001	TRICOR	48MG	TABLET / ORAL		RLD	2004-11-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021656-002	TRICOR	145MG	TABLET / ORAL		RLD	2004-11-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021656-001	TRICOR	48MG	TABLET / ORAL		RLD	2004-11-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021656-002	TRICOR	145MG	TABLET / ORAL		RLD	2004-11-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021656-001	TRICOR	48MG	TABLET / ORAL	AB	RLD	2004-11-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021656-002	TRICOR	145MG	TABLET / ORAL		RLD	2004-11-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021656-001	TRICOR	48MG	TABLET / ORAL	AB	RLD	2004-11-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021656-002	TRICOR	145MG	TABLET / ORAL		RLD	2004-11-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021656-001	TRICOR	48MG	TABLET / ORAL	AB	RLD	2004-11-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021656-002	TRICOR	145MG	TABLET / ORAL		RLD	2004-11-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021656-001	TRICOR	48MG	TABLET / ORAL	AB	RLD	2004-11-05	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021656-002	TRICOR	145MG	TABLET / ORAL		RLD	2004-11-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021656-001	TRICOR	48MG	TABLET / ORAL	AB	RLD	2004-11-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021656-002	TRICOR	145MG	TABLET / ORAL	AB	RLD, RS	2004-11-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021656-001	TRICOR	48MG	TABLET / ORAL	AB	RLD	2004-11-05	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021656-002	TRICOR	145MG	TABLET / ORAL	AB	RLD, RS	2004-11-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021656-001	TRICOR	48MG	TABLET / ORAL	AB	RLD	2004-11-05	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021656-002	TRICOR	145MG	TABLET / ORAL	AB	RLD, RS	2004-11-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021656-001	TRICOR	48MG	TABLET / ORAL	AB	RLD	2004-11-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021656-002	TRICOR	145MG	TABLET / ORAL	AB	RLD, RS	2004-11-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021656-001	TRICOR	48MG	TABLET / ORAL	AB	RLD	2004-11-05	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021656-002	TRICOR	145MG	TABLET / ORAL	AB	RLD, RS	2004-11-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021656-001	TRICOR	48MG	TABLET / ORAL	AB	RLD	2004-11-05	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021656-002	TRICOR	145MG	TABLET / ORAL	AB	RLD, RS	2004-11-05	`782e0a99824c…`

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
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021656-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021656-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021656-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021656-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021656-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021656-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021656-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021656-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021656-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021656-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021656-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021656-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021656-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021656-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021656-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021656-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021656-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021656-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021656-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021656-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021656-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021656-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021656-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021656-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021656-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021656-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021656-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021656-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021656-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021656-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021656-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021656-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021656-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N021656-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021656-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N021656-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021656-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021656-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021656-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021656-002	AB	1	`9b2671bbb829…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 108 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021656-001	7276249	2023-02-21		Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021656-001	7320802	2023-02-21	U-847		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021656-002	7276249	2023-02-21		Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021656-002	7320802	2023-02-21	U-847		`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021656-001	7276249	2023-02-21		Drug product	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021656-001	7320802	2023-02-21	U-847		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021656-002	7276249	2023-02-21		Drug product	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021656-002	7320802	2023-02-21	U-847		`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021656-001	7276249	2023-02-21		Drug product	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021656-001	7320802	2023-02-21	U-847		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021656-002	7276249	2023-02-21		Drug product	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021656-002	7320802	2023-02-21	U-847		`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021656-001	6375986	2020-09-21	U-615	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021656-001	7276249	2023-02-21		Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021656-001	7320802	2023-02-21	U-847		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021656-002	6375986	2020-09-21	U-615	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021656-002	7276249	2023-02-21		Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021656-002	7320802	2023-02-21	U-847		`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021656-001	7276249	2023-02-21		Drug product	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021656-001	7320802	2023-02-21	U-847		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021656-002	7276249	2023-02-21		Drug product	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021656-002	7320802	2023-02-21	U-847		`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021656-001	7276249	2023-02-21		Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021656-001	7320802	2023-02-21	U-847		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021656-002	7276249	2023-02-21		Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021656-002	7320802	2023-02-21	U-847		`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021656-001	7276249	2023-02-21		Drug product	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021656-001	7320802	2023-02-21	U-847		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021656-002	7276249	2023-02-21		Drug product	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021656-002	7320802	2023-02-21	U-847		`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021656-001	7276249	2023-02-21		Drug product	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021656-001	7320802	2023-02-21	U-847		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021656-002	7276249	2023-02-21		Drug product	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021656-002	7320802	2023-02-21	U-847		`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021656-001	6375986	2020-09-21	U-615	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021656-001	7276249	2023-02-21		Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021656-001	7320802	2023-02-21	U-847		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021656-002	6375986	2020-09-21	U-615	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021656-002	7276249	2023-02-21		Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021656-002	7320802	2023-02-21	U-847		`8869cabd3fbd…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68382-269-16	2020-02-28	C162847	48780-1	9d75b9d0-2425-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use Fenofibrate tablets for oral use safely and effectively. See full prescribing information for Fenofibrate tablets for oral use. Fenofibrate Tablets, for oral use Initial U.S. Approval: 1993
68382-269-16	2020-01-31	C162847	48780-1	9d75b9d0-2425-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use Fenofibrate tablets for oral use safely and effectively. See full prescribing information for Fenofibrate tablets for oral use. 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
68382-269-16	EA - Each	68382-269	57eda2fb-6498-4510-991c-cc6280e0c860	1	2016-10-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FENOFIBRATE	ACTIVE INGREDIENT	U202363UOS	FENOFIBRATE TABLET [ZYDUS PHARMACEUTICALS USA INC]	6
FENOFIBRATE	ACTIVE MOIETY	U202363UOS	FENOFIBRATE TABLET [ZYDUS PHARMACEUTICALS USA INC]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	FENOFIBRATE TABLET [ZYDUS PHARMACEUTICALS USA INC]	6
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	FENOFIBRATE TABLET [ZYDUS PHARMACEUTICALS USA INC]	6
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	FENOFIBRATE TABLET [ZYDUS PHARMACEUTICALS USA INC]	6
DOCUSATE SODIUM	INACTIVE INGREDIENT	F05Q2T2JA0	FENOFIBRATE TABLET [ZYDUS PHARMACEUTICALS USA INC]	6
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	FENOFIBRATE TABLET [ZYDUS PHARMACEUTICALS USA INC]	6
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	FENOFIBRATE TABLET [ZYDUS PHARMACEUTICALS USA INC]	6
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	FENOFIBRATE TABLET [ZYDUS PHARMACEUTICALS USA INC]	6
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	FENOFIBRATE TABLET [ZYDUS PHARMACEUTICALS USA INC]	6
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	FENOFIBRATE TABLET [ZYDUS PHARMACEUTICALS USA INC]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FENOFIBRATE TABLET [ZYDUS PHARMACEUTICALS USA INC]	6
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	FENOFIBRATE TABLET [ZYDUS PHARMACEUTICALS USA INC]	6
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	FENOFIBRATE TABLET [ZYDUS PHARMACEUTICALS USA INC]	6
SUCROSE	INACTIVE INGREDIENT	C151H8M554	FENOFIBRATE TABLET [ZYDUS PHARMACEUTICALS USA INC]	6
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	FENOFIBRATE TABLET [ZYDUS PHARMACEUTICALS USA INC]	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FENOFIBRATE TABLET [ZYDUS PHARMACEUTICALS USA INC]	6
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	FENOFIBRATE TABLET [ZYDUS PHARMACEUTICALS USA INC]	6

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
Tricor	FENOFIBRATE	A-S Medication Solutions	84b2af1b-365e-4723-ac5f-bc826ec47772	2024-04-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021656 application number: NDA021656

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
477562	fenofibrate 48 MG Oral Tablet	PSN	ffe2b024-fc89-411a-b22d-acb976022dd4	8
477562	fenofibrate 48 MG Oral Tablet	SCD	ffe2b024-fc89-411a-b22d-acb976022dd4	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68382-269-16	68382026916	90 TABLET in 1 BOTTLE (68382-269-16)	90 tablet	2016-02-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fenofibrate	Bryant Ranch Prepack	2021-12-22	HUMAN PRESCRIPTION DRUG LABEL	8
Fenofibrate	Zydus Pharmaceuticals USA Inc	2021-07-01	HUMAN PRESCRIPTION DRUG LABEL	42
Fenofibrate	Proficient Rx LP	2019-11-01	HUMAN PRESCRIPTION DRUG LABEL	3
Fenofibrate	NuCare Pharmaceuticals, Inc.	2017-02-09	HUMAN PRESCRIPTION DRUG LABEL	1