Fenofibric Acid

Product NDC: 68382-233
11-digit product format: 683820233
Labeler code: 68382
Product ID: 68382-233_7510c070-1b49-41a2-a3ea-cbbbde665013
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fenofibric Acid
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Zydus Pharmaceuticals USA Inc
Application: NDA022224
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2016-09-12
Marketing end: 0000-00-00
Substance: FENOFIBRIC ACID
Active strength: 135 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	68382-233		D	Discontinued by firm		2026-08-17
excluded package	package	68382-233	68382-233-16	D	Discontinued by firm		2026-08-17

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	68382-233-16	`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	68382-233-16	`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	68382-233-16	`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	68382-233-16	`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	68382-233-16	`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	68382-233-16	`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	68382-233-16	`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	68382-233-16	`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	68382-233-16	`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	68382-233-16	`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	68382-233-16	`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	68382-233-16	`557ba5c1ecfa…`	`9c80585c8c6e…`

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…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68382-233-16	2020-02-29	C162847	48780-1	9d75b9d0-c436-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use fenofibric acid delayed release capsules safely and effectively. See full prescribing information for fenofibric acid delayed release capsules. Fenofibric acid capsule, delayed release for oral use Initial U.S. Approval: 2008
68382-233-16	2020-01-31	C162847	48780-1	9d75b9d0-c436-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use fenofibric acid delayed release capsules safely and effectively. See full prescribing information for fenofibric acid delayed release capsules. Fenofibric acid capsule, delayed release for oral use Initial U.S. Approval: 2008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68382-233-16	EA - Each	68382-233	1ea711b6-bc86-4dd8-a60d-cdd72010b1ea	1	2017-03-06

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 [ZYDUS PHARMACEUTICALS USA INC]	21
FENOFIBRIC ACID	ACTIVE MOIETY	BGF9MN2HU1	FENOFIBRIC ACID CAPSULE, DELAYED RELEASE [ZYDUS PHARMACEUTICALS USA INC]	21

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68382-233-16	68382023316	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68382-233-16)	2016-09-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fenofibric Acid	Zydus Pharmaceuticals USA Inc \| AbbVie Inc.	2021-07-20	HUMAN PRESCRIPTION DRUG LABEL	61