Home NDC 70518-4284 Trintellix
Product NDC 70518-4284
11-digit product format 705184284
Labeler code 70518
Product ID 70518-4284_50249818-e49f-9873-e063-6394a90ac7d9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name vortioxetine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler REMEDYREPACK INC.
Application NDA204447
Marketing category NDA
Marketing start 2025-02-11
Substance VORTIOXETINE HYDROBROMIDE
Active strength 10 mg/1
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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TRINTELLIX VORTIOXETINE HYDROBROMIDE EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2013-09-30 N204447-004 TRINTELLIX VORTIOXETINE HYDROBROMIDE EQ 20MG BASE TABLET / ORAL RLD, RS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 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VORTIOXETINE HYDROBROMIDE 10 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1439808 Internal RxNorm lookup 1790886 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 70518-4284-0 Trintellix 30 in 1 BOX TABLET, FILM COATED 30 4 70518-4284-1 Trintellix 1 in 1 POUCH TABLET, FILM COATED 1 4 70518-4284-2 Trintellix 50 in 1 BOX TABLET, FILM COATED 50 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70518-4284 TRINTELLIX (VORTIOXETINE) TABLET, FILM COATED [REMEDYREPACK INC.] 1 Current NDC, 3 package rows 20250214_239215eb-be32-4286-9677-1e5556c6cccf.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 ndc (product): 70518-4284 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 RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70518-4284-0 70518428400 30 POUCH in 1 BOX (70518-4284-0) / 1 TABLET, FILM COATED in 1 POUCH (70518-4284-1) 30 pouch 2025-02-11 No No Current 70518-4284-1 70518428401 1 in 1 POUCH Historical 70518-4284-2 70518428402 50 POUCH in 1 BOX (70518-4284-2) / 1 TABLET, FILM COATED in 1 POUCH (70518-4284-1) 50 pouch 2026-04-22 No No Current