FIBRICOR

Product NDC: 69916-035
11-digit product format: 699160035
Labeler code: 69916
Product ID: 69916-035_31112335-e6c0-4c10-b5db-8cf4c4c74d65
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fenofibric Acid
Dosage form: TABLET
Route: ORAL
Labeler: Tribute Pharmaceuticals US, Inc.
Application: NDA022418
Marketing category: NDA
Marketing start: 2015-07-30
Marketing end: 0000-00-00
Substance: FENOFIBRIC ACID
Active strength: 35 mg/1
Pharmacologic classes: Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag: E
Listing certified through: 2017-12-31
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	69916-035		I	Inactivated by FDA		2026-08-17
excluded package	package	69916-035	69916-035-30	I	Inactivated by FDA		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 · 44 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		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69916-035-30	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69916-035-30	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69916-035-30	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69916-035-30	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69916-035-30	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69916-035-30	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69916-035-30	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69916-035-30	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69916-035-30	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
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	69916-035-30	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	69916-035-30	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	69916-035-30	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	69916-035-30	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	69916-035-30	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	69916-035-30	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	69916-035-30	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	69916-035-30	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	69916-035-30	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	69916-035-30	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	69916-035-30	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	69916-035-30	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	69916-035-30	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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
N022418-001	FIBRICOR	FENOFIBRIC ACID	35MG	TABLET / ORAL		RLD	2009-08-14
N022418-002	FIBRICOR	FENOFIBRIC ACID	105MG	TABLET / ORAL		RLD	2009-08-14

Orange Book patents#

Current patent rows page 1 of 1 · 14 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Submission date
N022418-001	7569612	2027-08-20	U-1000
N022418-001	7741373	2027-08-20	U-1059
N022418-001	7741374	2027-08-20	U-1060
N022418-001	7741374	2027-08-20	U-1061
N022418-001	7915247	2027-08-20	U-1000	2011-03-30
N022418-001	7915247	2027-08-20	U-1059	2011-03-30
N022418-001	7915247	2027-08-20	U-1061	2011-03-30
N022418-002	7569612	2027-08-20	U-1000
N022418-002	7741373	2027-08-20	U-1059
N022418-002	7741374	2027-08-20	U-1060
N022418-002	7741374	2027-08-20	U-1061
N022418-002	7915247	2027-08-20	U-1000
N022418-002	7915247	2027-08-20	U-1059
N022418-002	7915247	2027-08-20	U-1061

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022418-001	FIBRICOR	35MG	TABLET / ORAL	RLD	2009-08-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022418-002	FIBRICOR	105MG	TABLET / ORAL	RLD	2009-08-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022418-001	FIBRICOR	35MG	TABLET / ORAL	RLD	2009-08-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022418-002	FIBRICOR	105MG	TABLET / ORAL	RLD	2009-08-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022418-001	FIBRICOR	35MG	TABLET / ORAL	RLD	2009-08-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022418-002	FIBRICOR	105MG	TABLET / ORAL	RLD	2009-08-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022418-001	FIBRICOR	35MG	TABLET / ORAL	RLD	2009-08-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022418-002	FIBRICOR	105MG	TABLET / ORAL	RLD, RS	2009-08-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022418-001	FIBRICOR	35MG	TABLET / ORAL	RLD	2009-08-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022418-002	FIBRICOR	105MG	TABLET / ORAL	RLD	2009-08-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022418-001	FIBRICOR	35MG	TABLET / ORAL	RLD	2009-08-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022418-002	FIBRICOR	105MG	TABLET / ORAL	RLD	2009-08-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022418-001	FIBRICOR	35MG	TABLET / ORAL	RLD	2009-08-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022418-002	FIBRICOR	105MG	TABLET / ORAL	RLD	2009-08-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022418-001	FIBRICOR	35MG	TABLET / ORAL	RLD	2009-08-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022418-002	FIBRICOR	105MG	TABLET / ORAL	RLD	2009-08-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022418-001	FIBRICOR	35MG	TABLET / ORAL	RLD	2009-08-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022418-002	FIBRICOR	105MG	TABLET / ORAL	RLD	2009-08-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022418-001	FIBRICOR	35MG	TABLET / ORAL	RLD	2009-08-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022418-002	FIBRICOR	105MG	TABLET / ORAL	RLD	2009-08-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022418-001	FIBRICOR	35MG	TABLET / ORAL	RLD	2009-08-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022418-002	FIBRICOR	105MG	TABLET / ORAL	RLD	2009-08-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022418-001	FIBRICOR	35MG	TABLET / ORAL	RLD	2009-08-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022418-002	FIBRICOR	105MG	TABLET / ORAL	RLD	2009-08-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022418-001	FIBRICOR	35MG	TABLET / ORAL	RLD	2009-08-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022418-002	FIBRICOR	105MG	TABLET / ORAL	RLD	2009-08-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022418-001	FIBRICOR	35MG	TABLET / ORAL	RLD	2009-08-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022418-002	FIBRICOR	105MG	TABLET / ORAL	RLD	2009-08-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022418-001	FIBRICOR	35MG	TABLET / ORAL	RLD	2009-08-14	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022418-002	FIBRICOR	105MG	TABLET / ORAL	RLD	2009-08-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022418-001	FIBRICOR	35MG	TABLET / ORAL	RLD	2009-08-14	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022418-002	FIBRICOR	105MG	TABLET / ORAL	RLD, RS	2009-08-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022418-001	FIBRICOR	35MG	TABLET / ORAL	RLD	2009-08-14	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022418-002	FIBRICOR	105MG	TABLET / ORAL	RLD, RS	2009-08-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022418-001	FIBRICOR	35MG	TABLET / ORAL	RLD	2009-08-14	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022418-002	FIBRICOR	105MG	TABLET / ORAL	RLD, RS	2009-08-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022418-001	FIBRICOR	35MG	TABLET / ORAL	RLD	2009-08-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022418-002	FIBRICOR	105MG	TABLET / ORAL	RLD, RS	2009-08-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022418-001	FIBRICOR	35MG	TABLET / ORAL	RLD	2009-08-14	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022418-002	FIBRICOR	105MG	TABLET / ORAL	RLD, RS	2009-08-14	`bb7c543d1eb4…`

Observed Orange Book patent history#

Patent history page 1 of 15 · 588 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022418-001	7569612	2027-08-20	U-1000		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022418-001	7741373	2027-08-20	U-1059		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022418-001	7741374	2027-08-20	U-1061		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022418-001	7741374	2027-08-20	U-1060		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022418-001	7915247	2027-08-20	U-1061	2011-03-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022418-001	7915247	2027-08-20	U-1059	2011-03-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022418-001	7915247	2027-08-20	U-1000	2011-03-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022418-002	7569612	2027-08-20	U-1000		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022418-002	7741373	2027-08-20	U-1059		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022418-002	7741374	2027-08-20	U-1061		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022418-002	7741374	2027-08-20	U-1060		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022418-002	7915247	2027-08-20	U-1000		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022418-002	7915247	2027-08-20	U-1059		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022418-002	7915247	2027-08-20	U-1061		`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022418-001	7569612	2027-08-20	U-1000		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022418-001	7741373	2027-08-20	U-1059		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022418-001	7741374	2027-08-20	U-1061		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022418-001	7741374	2027-08-20	U-1060		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022418-001	7915247	2027-08-20	U-1061	2011-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022418-001	7915247	2027-08-20	U-1059	2011-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022418-001	7915247	2027-08-20	U-1000	2011-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022418-002	7569612	2027-08-20	U-1000		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022418-002	7741373	2027-08-20	U-1059		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022418-002	7741374	2027-08-20	U-1061		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022418-002	7741374	2027-08-20	U-1060		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022418-002	7915247	2027-08-20	U-1000		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022418-002	7915247	2027-08-20	U-1059		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022418-002	7915247	2027-08-20	U-1061		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022418-001	7569612	2027-08-20	U-1000		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022418-001	7741373	2027-08-20	U-1059		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022418-001	7741374	2027-08-20	U-1061		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022418-001	7741374	2027-08-20	U-1060		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022418-001	7915247	2027-08-20	U-1061	2011-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022418-001	7915247	2027-08-20	U-1059	2011-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022418-001	7915247	2027-08-20	U-1000	2011-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022418-002	7569612	2027-08-20	U-1000		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022418-002	7741373	2027-08-20	U-1059		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022418-002	7741374	2027-08-20	U-1061		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022418-002	7741374	2027-08-20	U-1060		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022418-002	7915247	2027-08-20	U-1000		`31067a03dcf5…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69916-035-30	2020-01-31	C162847	48780-1	9d75b9cf-fcc8-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use FIBRICOR ® (fenofibric acid) Tablets safely and effectively. See full prescribing information for FIBRICOR. FIBRICOR ® (fenofibric acid) Tablets, for oral use Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69916-035-30	FIBRICOR	30 in 1 BOTTLE, PLASTIC	TABLET	30		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69916-035-30	EA - Each	69916-035	4b53bf65-ebe8-4009-b3ad-d716423db874	1	2016-04-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Fenofibric Acid	ACTIVE INGREDIENT	BGF9MN2HU1	FIBRICOR (FENOFIBRIC ACID) TABLET [TRIBUTE PHARMACEUTICALS US, INC.]	2
Fenofibric Acid	ACTIVE MOIETY	BGF9MN2HU1	FIBRICOR (FENOFIBRIC ACID) TABLET [TRIBUTE PHARMACEUTICALS US, INC.]	2
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	FIBRICOR (FENOFIBRIC ACID) TABLET [TRIBUTE PHARMACEUTICALS US, INC.]	2
Copovidone K25-31	INACTIVE INGREDIENT	D9C330MD8B	FIBRICOR (FENOFIBRIC ACID) TABLET [TRIBUTE PHARMACEUTICALS US, INC.]	2
crospovidone	INACTIVE INGREDIENT	68401960MK	FIBRICOR (FENOFIBRIC ACID) TABLET [TRIBUTE PHARMACEUTICALS US, INC.]	2
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	FIBRICOR (FENOFIBRIC ACID) TABLET [TRIBUTE PHARMACEUTICALS US, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69916-035	FIBRICOR (FENOFIBRIC ACID) TABLET [TRIBUTE PHARMACEUTICALS US, INC.]	3	Legacy NDC, 1 package rows	20160108_777b0c6b-cd25-454d-a35b-d2df9b44497f.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
860880	fenofibric acid 105 MG Oral Tablet	PSN	777b0c6b-cd25-454d-a35b-d2df9b44497f	3
860886	fenofibric acid 35 MG Oral Tablet	PSN	777b0c6b-cd25-454d-a35b-d2df9b44497f	3
860884	FIBRICOR 105 MG Oral Tablet	PSN	777b0c6b-cd25-454d-a35b-d2df9b44497f	3
860888	FIBRICOR 35 MG Oral Tablet	PSN	777b0c6b-cd25-454d-a35b-d2df9b44497f	3
860884	fenofibric acid 105 MG Oral Tablet [Fibricor]	SBD	777b0c6b-cd25-454d-a35b-d2df9b44497f	3
860888	fenofibric acid 35 MG Oral Tablet [Fibricor]	SBD	777b0c6b-cd25-454d-a35b-d2df9b44497f	3
860880	fenofibric acid 105 MG Oral Tablet	SCD	777b0c6b-cd25-454d-a35b-d2df9b44497f	3
860886	fenofibric acid 35 MG Oral Tablet	SCD	777b0c6b-cd25-454d-a35b-d2df9b44497f	3
860884	Fibricor (fenofibric acid 105 MG) Oral Tablet	SY	777b0c6b-cd25-454d-a35b-d2df9b44497f	3
860888	Fibricor (fenofibric acid 35 MG) Oral Tablet	SY	777b0c6b-cd25-454d-a35b-d2df9b44497f	3
860884	Fibricor 105 MG Oral Tablet	SY	777b0c6b-cd25-454d-a35b-d2df9b44497f	3
860888	Fibricor 35 MG Oral Tablet	SY	777b0c6b-cd25-454d-a35b-d2df9b44497f	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
69916-035-30	69916003530	30 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
FIBRICOR	Tribute Pharmaceuticals US, Inc. \| Mutual Pharmaceutical Company, Inc.	2016-01-08	HUMAN PRESCRIPTION DRUG LABEL	3