Trintellix

Orange BookUNIISPLATC N06AX26

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerTakeda Pharmaceuticals America, Inc.

CountryUS (United States)

ATC codeN06AX26

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
6476472007
1 BOTTLE in 1 CARTON (64764-720-07) / 7 TABLET, FILM COATED in 1 BOTTLE
ndc11
6476472009
30 TABLET, FILM COATED in 1 BOTTLE (64764-720-09)
ndc11
6476472030
30 TABLET, FILM COATED in 1 BOTTLE (64764-720-30)
ndc11
6476472077
500 TABLET, FILM COATED in 1 BOTTLE (64764-720-77)
ndc11
6476472090
90 TABLET, FILM COATED in 1 BOTTLE (64764-720-90)

Annotations

UNII (FDA Substance ID)

TKS641KOAY

VORTIOXETINE HYDROBROMIDE

RxCUI 1439834

Orange Book

N204447

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "TKS641KOAY",
    "rxcui": "1439834",
    "inchikey": "VNGRUFUIHGGOOM-UHFFFAOYSA-N",
    "display_name": "VORTIOXETINE HYDROBROMIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "239215eb-be32-4286-9677-1e5556c6cccf": {
      "match": "brand_token",
      "title": "TRINTELLIX (VORTIOXETINE) TABLET, FILM COATED [REMEDYREPACK INC.]",
      "spl_version": "4",
      "published_date": "2026-04-27"
    }
  },
  "productid": "64764-720_186fcd68-438e-427f-ae19-8042c15baa78",
  "productndc": "64764-720",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "204447",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 5MG BASE",
        "product_no": "001",
        "approval_date": "Sep 30, 2013"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 10MG BASE",
        "product_no": "002",
        "approval_date": "Sep 30, 2013"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "003",
        "approval_date": "Sep 30, 2013"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 20MG BASE",
        "product_no": "004",
        "approval_date": "Sep 30, 2013"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "VORTIOXETINE HYDROBROMIDE",
  "proprietary_name": "Trintellix",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA204447",
  "marketing_category": "NDA",
  "nonproprietary_name": "vortioxetine",
  "start_marketing_date": "20131002",
  "active_numerator_strength": "5"
}

Related drugs

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