Brintellix

Product NDC: 64764-560
11-digit product format: 647640560
Labeler code: 64764
Product ID: 64764-560_cc70d6dd-e54b-483d-83f5-762a6cce455a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: vortioxetine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Takeda Pharmaceuticals America, Inc.
Application: NDA204447
Marketing category: NDA
Marketing start: 2013-10-02
Marketing end: 0000-00-00
Substance: VORTIOXETINE HYDROBROMIDE
Active strength: 10 mg/1
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	64764-560		D	Discontinued by firm	2026-08-17
excluded package	package	64764-560	64764-560-07	D	Discontinued by firm	2026-08-17
excluded package	package	64764-560	64764-560-09	D	Discontinued by firm	2026-08-17
excluded package	package	64764-560	64764-560-30	D	Discontinued by firm	2026-08-17
excluded package	package	64764-560	64764-560-77	D	Discontinued by firm	2026-08-17
excluded package	package	64764-560	64764-560-90	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 2 · 72 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	64764-560-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64764-560-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64764-560-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64764-560-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64764-560-77	`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	64764-560-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64764-560-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64764-560-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64764-560-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64764-560-77	`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	64764-560-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64764-560-09	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64764-560-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64764-560-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64764-560-77	`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	64764-560-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64764-560-09	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64764-560-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64764-560-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64764-560-77	`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	64764-560-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64764-560-09	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64764-560-07	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64764-560-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64764-560-77	`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	64764-560-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64764-560-09	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64764-560-07	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64764-560-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64764-560-77	`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	64764-560-90	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64764-560-09	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64764-560-07	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64764-560-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64764-560-77	`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	64764-560-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64764-560-09	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64764-560-07	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64764-560-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64764-560-77	`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	64764-560-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64764-560-09	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64764-560-07	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64764-560-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64764-560-77	`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	64764-560-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64764-560-09	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64764-560-07	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64764-560-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64764-560-77	`ad56d346431e…`	`cc804d4bbf1e…`

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N204447-001	TRINTELLIX	VORTIOXETINE HYDROBROMIDE	EQ 5MG BASE	TABLET / ORAL	RLD	2013-09-30
N204447-002	TRINTELLIX	VORTIOXETINE HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	RLD	2013-09-30
N204447-003	TRINTELLIX	VORTIOXETINE HYDROBROMIDE	EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2013-09-30
N204447-004	TRINTELLIX	VORTIOXETINE HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	RLD, RS	2013-09-30

Orange Book patents#

Current patent rows page 1 of 1 · 80 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N204447-001	7144884	2026-06-17	U-1439	Drug substance, Drug product	2013-10-16
N204447-001	7144884*PED	2026-12-17		Pediatric extension
N204447-001	11458134	2027-06-15	U-3463	Drug product	2022-11-02
N204447-001	8969355	2027-06-15	U-1668		2015-03-19
N204447-001	9125908	2027-06-15	U-2309		2018-05-24
N204447-001	9125909	2027-06-15	U-2309		2018-05-24
N204447-001	9125910	2027-06-15	U-2309		2018-05-24
N204447-001	9227946	2027-06-15	U-1668		2016-01-21
N204447-001	9861630	2027-06-15	U-1668		2018-01-18
N204447-001	11458134*PED	2027-12-15		Pediatric extension
N204447-001	8969355*PED	2027-12-15		Pediatric extension
N204447-001	9125908*PED	2027-12-15		Pediatric extension
N204447-001	9125909*PED	2027-12-15		Pediatric extension
N204447-001	9125910*PED	2027-12-15		Pediatric extension
N204447-001	9227946*PED	2027-12-15		Pediatric extension
N204447-001	9861630*PED	2027-12-15		Pediatric extension
N204447-001	8722684	2031-06-30		Drug substance, Drug product	2014-06-09
N204447-001	8722684*PED	2031-12-30		Pediatric extension
N204447-001	9278096	2032-03-21	U-2436		2018-11-13
N204447-001	9278096*PED	2032-09-21		Pediatric extension
N204447-002	7144884	2026-06-17	U-1439	Drug substance, Drug product	2013-10-16
N204447-002	7144884*PED	2026-12-17		Pediatric extension
N204447-002	11458134	2027-06-15	U-3463	Drug product	2022-11-02
N204447-002	8969355	2027-06-15	U-1668		2015-03-19
N204447-002	9125908	2027-06-15	U-2309		2018-05-24
N204447-002	9125909	2027-06-15	U-2309		2018-05-24
N204447-002	9125910	2027-06-15	U-2309		2018-05-24
N204447-002	9227946	2027-06-15	U-1668		2016-01-21
N204447-002	9861630	2027-06-15	U-1668		2018-01-18
N204447-002	11458134*PED	2027-12-15		Pediatric extension
N204447-002	8969355*PED	2027-12-15		Pediatric extension
N204447-002	9125908*PED	2027-12-15		Pediatric extension
N204447-002	9125909*PED	2027-12-15		Pediatric extension
N204447-002	9125910*PED	2027-12-15		Pediatric extension
N204447-002	9227946*PED	2027-12-15		Pediatric extension
N204447-002	9861630*PED	2027-12-15		Pediatric extension
N204447-002	8722684	2031-06-30		Drug substance, Drug product	2014-06-09
N204447-002	8722684*PED	2031-12-30		Pediatric extension
N204447-002	9278096	2032-03-21	U-2436		2018-11-13
N204447-002	9278096*PED	2032-09-21		Pediatric extension
N204447-003	7144884	2026-06-17	U-1439	Drug substance, Drug product	2013-10-16
N204447-003	7144884*PED	2026-12-17		Pediatric extension
N204447-003	11458134	2027-06-15	U-3463	Drug product	2022-11-02
N204447-003	8969355	2027-06-15	U-1668		2015-03-19
N204447-003	9125908	2027-06-15	U-2309		2018-05-24
N204447-003	9125909	2027-06-15	U-2309		2018-05-24
N204447-003	9125910	2027-06-15	U-2309		2018-05-24
N204447-003	9227946	2027-06-15	U-1668		2016-01-21
N204447-003	9861630	2027-06-15	U-1668		2018-01-18
N204447-003	11458134*PED	2027-12-15		Pediatric extension
N204447-003	8969355*PED	2027-12-15		Pediatric extension
N204447-003	9125908*PED	2027-12-15		Pediatric extension
N204447-003	9125909*PED	2027-12-15		Pediatric extension
N204447-003	9125910*PED	2027-12-15		Pediatric extension
N204447-003	9227946*PED	2027-12-15		Pediatric extension
N204447-003	9861630*PED	2027-12-15		Pediatric extension
N204447-003	8722684	2031-06-30		Drug substance, Drug product	2014-06-09
N204447-003	8722684*PED	2031-12-30		Pediatric extension
N204447-003	9278096	2032-03-21	U-2436		2018-11-13
N204447-003	9278096*PED	2032-09-21		Pediatric extension
N204447-004	7144884	2026-06-17	U-1439	Drug substance, Drug product	2013-10-16
N204447-004	7144884*PED	2026-12-17		Pediatric extension
N204447-004	11458134	2027-06-15	U-3463	Drug product	2022-11-02
N204447-004	8969355	2027-06-15	U-1668		2015-03-19
N204447-004	9125908	2027-06-15	U-2309		2018-05-24
N204447-004	9125909	2027-06-15	U-2309		2018-05-24
N204447-004	9125910	2027-06-15	U-2309		2018-05-24
N204447-004	9227946	2027-06-15	U-1668		2016-01-21
N204447-004	9861630	2027-06-15	U-1668		2018-01-18
N204447-004	11458134*PED	2027-12-15		Pediatric extension
N204447-004	8969355*PED	2027-12-15		Pediatric extension
N204447-004	9125908*PED	2027-12-15		Pediatric extension
N204447-004	9125909*PED	2027-12-15		Pediatric extension
N204447-004	9125910*PED	2027-12-15		Pediatric extension
N204447-004	9227946*PED	2027-12-15		Pediatric extension
N204447-004	9861630*PED	2027-12-15		Pediatric extension
N204447-004	8722684	2031-06-30		Drug substance, Drug product	2014-06-09
N204447-004	8722684*PED	2031-12-30		Pediatric extension
N204447-004	9278096	2032-03-21	U-2436		2018-11-13
N204447-004	9278096*PED	2032-09-21		Pediatric extension

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 8 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N204447-001	M-232	2026-08-23
N204447-001	PED	2027-02-23
N204447-002	M-232	2026-08-23
N204447-002	PED	2027-02-23
N204447-003	M-232	2026-08-23
N204447-003	PED	2027-02-23
N204447-004	M-232	2026-08-23
N204447-004	PED	2027-02-23

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 5 · 168 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	N204447-001	TRINTELLIX	EQ 5MG BASE	TABLET / ORAL	RLD	2013-09-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-002	TRINTELLIX	EQ 10MG BASE	TABLET / ORAL	RLD	2013-09-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-003	TRINTELLIX	EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2013-09-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-004	TRINTELLIX	EQ 20MG BASE	TABLET / ORAL	RLD, RS	2013-09-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204447-001	TRINTELLIX	EQ 5MG BASE	TABLET / ORAL	RLD	2013-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204447-002	TRINTELLIX	EQ 10MG BASE	TABLET / ORAL	RLD	2013-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204447-003	TRINTELLIX	EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2013-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204447-004	TRINTELLIX	EQ 20MG BASE	TABLET / ORAL	RLD, RS	2013-09-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204447-001	TRINTELLIX	EQ 5MG BASE	TABLET / ORAL	RLD	2013-09-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204447-002	TRINTELLIX	EQ 10MG BASE	TABLET / ORAL	RLD	2013-09-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204447-003	TRINTELLIX	EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2013-09-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204447-004	TRINTELLIX	EQ 20MG BASE	TABLET / ORAL	RLD, RS	2013-09-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204447-001	TRINTELLIX	EQ 5MG BASE	TABLET / ORAL	RLD	2013-09-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204447-002	TRINTELLIX	EQ 10MG BASE	TABLET / ORAL	RLD	2013-09-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204447-003	TRINTELLIX	EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2013-09-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204447-004	TRINTELLIX	EQ 20MG BASE	TABLET / ORAL	RLD, RS	2013-09-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204447-001	TRINTELLIX	EQ 5MG BASE	TABLET / ORAL	RLD	2013-09-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204447-002	TRINTELLIX	EQ 10MG BASE	TABLET / ORAL	RLD	2013-09-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204447-003	TRINTELLIX	EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2013-09-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204447-004	TRINTELLIX	EQ 20MG BASE	TABLET / ORAL	RLD, RS	2013-09-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204447-001	TRINTELLIX	EQ 5MG BASE	TABLET / ORAL	RLD	2013-09-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204447-002	TRINTELLIX	EQ 10MG BASE	TABLET / ORAL	RLD	2013-09-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204447-003	TRINTELLIX	EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2013-09-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204447-004	TRINTELLIX	EQ 20MG BASE	TABLET / ORAL	RLD, RS	2013-09-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204447-001	TRINTELLIX	EQ 5MG BASE	TABLET / ORAL	RLD	2013-09-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204447-002	TRINTELLIX	EQ 10MG BASE	TABLET / ORAL	RLD	2013-09-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204447-003	TRINTELLIX	EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2013-09-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204447-004	TRINTELLIX	EQ 20MG BASE	TABLET / ORAL	RLD, RS	2013-09-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204447-001	TRINTELLIX	EQ 5MG BASE	TABLET / ORAL	RLD	2013-09-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204447-002	TRINTELLIX	EQ 10MG BASE	TABLET / ORAL	RLD	2013-09-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204447-003	TRINTELLIX	EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2013-09-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204447-004	TRINTELLIX	EQ 20MG BASE	TABLET / ORAL	RLD, RS	2013-09-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204447-001	TRINTELLIX	EQ 5MG BASE	TABLET / ORAL	RLD	2013-09-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204447-002	TRINTELLIX	EQ 10MG BASE	TABLET / ORAL	RLD	2013-09-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204447-003	TRINTELLIX	EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2013-09-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204447-004	TRINTELLIX	EQ 20MG BASE	TABLET / ORAL	RLD, RS	2013-09-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204447-001	TRINTELLIX	EQ 5MG BASE	TABLET / ORAL	RLD	2013-09-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204447-002	TRINTELLIX	EQ 10MG BASE	TABLET / ORAL	RLD	2013-09-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204447-003	TRINTELLIX	EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2013-09-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204447-004	TRINTELLIX	EQ 20MG BASE	TABLET / ORAL	RLD, RS	2013-09-30	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-04-04 05:41 UTC	2022-04	N204447-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N204447-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N204447-004	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N204447-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N204447-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N204447-004	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N204447-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N204447-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N204447-004	AB	1	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 64 · 2,528 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N204447-001	7144884	2026-06-17	U-1439	Drug substance, Drug product	2013-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-001	7144884*PED	2026-12-17		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-001	11458134	2027-06-15	U-3463	Drug product	2022-11-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-001	8969355	2027-06-15	U-1668		2015-03-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-001	9125908	2027-06-15	U-2309		2018-05-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-001	9125909	2027-06-15	U-2309		2018-05-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-001	9125910	2027-06-15	U-2309		2018-05-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-001	9227946	2027-06-15	U-1668		2016-01-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-001	9861630	2027-06-15	U-1668		2018-01-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-001	11458134*PED	2027-12-15		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-001	8969355*PED	2027-12-15		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-001	9125908*PED	2027-12-15		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-001	9125909*PED	2027-12-15		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-001	9125910*PED	2027-12-15		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-001	9227946*PED	2027-12-15		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-001	9861630*PED	2027-12-15		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-001	8722684	2031-06-30		Drug substance, Drug product	2014-06-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-001	8722684*PED	2031-12-30		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-001	9278096	2032-03-21	U-2436		2018-11-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-001	9278096*PED	2032-09-21		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-002	7144884	2026-06-17	U-1439	Drug substance, Drug product	2013-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-002	7144884*PED	2026-12-17		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-002	11458134	2027-06-15	U-3463	Drug product	2022-11-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-002	8969355	2027-06-15	U-1668		2015-03-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-002	9125908	2027-06-15	U-2309		2018-05-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-002	9125909	2027-06-15	U-2309		2018-05-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-002	9125910	2027-06-15	U-2309		2018-05-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-002	9227946	2027-06-15	U-1668		2016-01-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-002	9861630	2027-06-15	U-1668		2018-01-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-002	11458134*PED	2027-12-15		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-002	8969355*PED	2027-12-15		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-002	9125908*PED	2027-12-15		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-002	9125909*PED	2027-12-15		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-002	9125910*PED	2027-12-15		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-002	9227946*PED	2027-12-15		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-002	9861630*PED	2027-12-15		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-002	8722684	2031-06-30		Drug substance, Drug product	2014-06-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-002	8722684*PED	2031-12-30		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-002	9278096	2032-03-21	U-2436		2018-11-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-002	9278096*PED	2032-09-21		Pediatric extension		`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 11 · 420 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N204447-001	M-232	2026-08-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-001	PED	2027-02-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-002	M-232	2026-08-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-002	PED	2027-02-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-003	M-232	2026-08-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-003	PED	2027-02-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-004	M-232	2026-08-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-004	PED	2027-02-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204447-001	M-232	2026-08-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204447-001	PED	2027-02-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204447-002	M-232	2026-08-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204447-002	PED	2027-02-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204447-003	M-232	2026-08-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204447-003	PED	2027-02-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204447-004	M-232	2026-08-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204447-004	PED	2027-02-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204447-001	M-232	2026-08-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204447-001	PED	2027-02-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204447-002	M-232	2026-08-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204447-002	PED	2027-02-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204447-003	M-232	2026-08-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204447-003	PED	2027-02-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204447-004	M-232	2026-08-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204447-004	PED	2027-02-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204447-001	M-232	2026-08-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204447-001	PED	2027-02-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204447-002	M-232	2026-08-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204447-002	PED	2027-02-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204447-003	M-232	2026-08-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204447-003	PED	2027-02-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204447-004	M-232	2026-08-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204447-004	PED	2027-02-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204447-001	M-232	2026-08-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204447-001	PED	2027-02-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204447-002	M-232	2026-08-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204447-002	PED	2027-02-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204447-003	M-232	2026-08-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204447-003	PED	2027-02-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204447-004	M-232	2026-08-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204447-004	PED	2027-02-23	`fd3edfee7708…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64764-560-30	EA - Each	64764-560	00794264-8d41-43e3-9b9a-7667b6a54b2a	1	2013-11-04

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Trintellix	VORTIOXETINE	REMEDYREPACK INC.	239215eb-be32-4286-9677-1e5556c6cccf	2026-04-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 204447 application number: NDA204447
Trintellix	VORTIOXETINE	REMEDYREPACK INC.	bd0107e5-1cb9-4b40-a6af-fa65fcbe6b4e	2026-04-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 204447 application number: NDA204447
Trintellix	VORTIOXETINE	Cardinal Health 107, LLC	cb1e9df4-dd74-4073-9d78-bb55593dd000	2026-02-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 204447 application number: NDA204447
Trintellix	VORTIOXETINE	Takeda Pharmaceuticals America, Inc.	1a5b68e2-14d0-419d-9ec6-1ca97145e838	2025-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 204447 application number: NDA204447

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
TKS641KOAY	VORTIOXETINE HYDROBROMIDE	960203-27-4	VORTIOXETINE HYDROBROMIDE
3O2K1S3WQV	VORTIOXETINE	508233-74-7	vortioxetine