Trintellix

Product NDC: 70518-2642
Requested package NDC: 70518-2642-0
11-digit product format: 705182642
Labeler code: 70518
Product ID: 70518-2642_dc760e13-7db8-3808-e053-2a95a90a9327
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: vortioxetine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: NDA204447
Marketing category: NDA
Marketing start: 2020-03-24
Marketing end: 0000-00-00
Substance: VORTIOXETINE HYDROBROMIDE
Active strength: 20 mg/1
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70518-2642	70518-2642-0	D	Discontinued by firm		2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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TRINTELLIX	VORTIOXETINE HYDROBROMIDE	EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2013-09-30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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	N204447-001	TRINTELLIX	EQ 5MG BASE	TABLET / ORAL	RLD	2013-09-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204447-002	TRINTELLIX	EQ 10MG BASE	TABLET / ORAL	RLD	2013-09-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	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	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204447-004	TRINTELLIX	EQ 20MG BASE	TABLET / ORAL	RLD, RS	2013-09-30	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 80 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-01 22:54:32	2026-06	N204447-001	7144884	2026-06-17	U-1439	Drug substance, Drug product	2013-10-16	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204447-001	7144884*PED	2026-12-17		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204447-001	11458134	2027-06-15	U-3463	Drug product	2022-11-02	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204447-001	8969355	2027-06-15	U-1668		2015-03-19	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204447-001	9125908	2027-06-15	U-2309		2018-05-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204447-001	9125909	2027-06-15	U-2309		2018-05-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204447-001	9125910	2027-06-15	U-2309		2018-05-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204447-001	9227946	2027-06-15	U-1668		2016-01-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204447-001	9861630	2027-06-15	U-1668		2018-01-18	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204447-001	11458134*PED	2027-12-15		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204447-001	8969355*PED	2027-12-15		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204447-001	9125908*PED	2027-12-15		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204447-001	9125909*PED	2027-12-15		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204447-001	9125910*PED	2027-12-15		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204447-001	9227946*PED	2027-12-15		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204447-001	9861630*PED	2027-12-15		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204447-001	8722684	2031-06-30		Drug substance, Drug product	2014-06-09	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204447-001	8722684*PED	2031-12-30		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204447-001	9278096	2032-03-21	U-2436		2018-11-13	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204447-001	9278096*PED	2032-09-21		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204447-002	7144884	2026-06-17	U-1439	Drug substance, Drug product	2013-10-16	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204447-002	7144884*PED	2026-12-17		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204447-002	11458134	2027-06-15	U-3463	Drug product	2022-11-02	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204447-002	8969355	2027-06-15	U-1668		2015-03-19	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204447-002	9125908	2027-06-15	U-2309		2018-05-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204447-002	9125909	2027-06-15	U-2309		2018-05-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204447-002	9125910	2027-06-15	U-2309		2018-05-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204447-002	9227946	2027-06-15	U-1668		2016-01-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204447-002	9861630	2027-06-15	U-1668		2018-01-18	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204447-002	11458134*PED	2027-12-15		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204447-002	8969355*PED	2027-12-15		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204447-002	9125908*PED	2027-12-15		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204447-002	9125909*PED	2027-12-15		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204447-002	9125910*PED	2027-12-15		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204447-002	9227946*PED	2027-12-15		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204447-002	9861630*PED	2027-12-15		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204447-002	8722684	2031-06-30		Drug substance, Drug product	2014-06-09	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204447-002	8722684*PED	2031-12-30		Pediatric extension		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204447-002	9278096	2032-03-21	U-2436		2018-11-13	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204447-002	9278096*PED	2032-09-21		Pediatric extension		`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-01 22:54:32	2026-06	N204447-001	M-232	2026-08-23	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204447-001	PED	2027-02-23	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204447-002	M-232	2026-08-23	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204447-002	PED	2027-02-23	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204447-003	M-232	2026-08-23	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204447-003	PED	2027-02-23	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204447-004	M-232	2026-08-23	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N204447-004	PED	2027-02-23	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70518-2642-0	EA - Each	70518-2642	0652db9d-5d9b-4b65-b726-374f4099a583	1	2026-01-08
70518-2642-1	EA - Each	70518-2642	9b09d335-1d87-4bd7-ae7d-7dfbc0289244	1	2026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-2642	TRINTELLIX (VORTIOXETINE) TABLET, FILM COATED [REMEDYREPACK INC.]	7	Legacy NDC	20250418_e572a091-cad9-4ffa-a8eb-28181c0a8222.zip

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-2642-0	70518264200	30 POUCH in 1 BOX (70518-2642-0) > 1 TABLET, FILM COATED in 1 POUCH (70518-2642-1)	30 pouch	2020-03-24	0000-00-00	No	No	Current