Home NDC 64764-720-90 Trintellix
Product NDC 64764-720
Requested package NDC 64764-720-90
11-digit product format 647640720
Labeler code 64764
Product ID 64764-720_186fcd68-438e-427f-ae19-8042c15baa78
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
Substance VORTIOXETINE HYDROBROMIDE
Active strength 5 mg/1
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 64764-720 64764-720-90 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
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 TE codes 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TRINTELLIX VORTIOXETINE HYDROBROMIDE EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2013-09-30 N204447-004 TRINTELLIX VORTIOXETINE HYDROBROMIDE EQ 20MG BASE TABLET / ORAL RLD, RS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.
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 Product TE source text 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# 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.
Additional Listing Data#
Finished product Yes
Brand name base Trintellix
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VORTIOXETINE HYDROBROMIDE 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination TKS641KOAY Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1439808 Internal RxNorm lookup 1439810 Internal RxNorm lookup 1439812 Internal RxNorm lookup 1790886 Internal RxNorm lookup 1790890 Internal RxNorm lookup 1790892 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 64764-720-07 Trintellix 1 in 1 CARTON TABLET, FILM COATED 1 18 64764-720-07 Trintellix 7 in 1 BOTTLE TABLET, FILM COATED 7 18 64764-720-09 Trintellix 30 in 1 BOTTLE TABLET, FILM COATED 30 18 64764-720-30 Trintellix 30 in 1 BOTTLE TABLET, FILM COATED 30 18 64764-720-77 Trintellix 500 in 1 BOTTLE TABLET, FILM COATED 500 18 64764-720-90 Trintellix 90 in 1 BOTTLE TABLET, FILM COATED 90 18
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64764-720 TRINTELLIX (VORTIOXETINE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.] 18 Current NDC, Legacy NDC, 6 package rows 20250311_1a5b68e2-14d0-419d-9ec6-1ca97145e838.zip
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 ndc (package): 64764-720-90 ndc (product): 64764-720 ndc11 (package): 64764072090
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 64764-720-90 64764072090 90 TABLET, FILM COATED in 1 BOTTLE (64764-720-90) 2013-10-02 0000-00-00 No No Current