NDC 64764-550

Brintellix

Vortioxetine

Brintellix is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Takeda Pharmaceuticals America, Inc.. The primary component is Vortioxetine Hydrobromide.

Product ID64764-550_cc70d6dd-e54b-483d-83f5-762a6cce455a
NDC64764-550
Product TypeHuman Prescription Drug
Proprietary NameBrintellix
Generic NameVortioxetine
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2013-10-02
Marketing CategoryNDA / NDA
Application NumberNDA204447
Labeler NameTakeda Pharmaceuticals America, Inc.
Substance NameVORTIOXETINE HYDROBROMIDE
Active Ingredient Strength5 mg/1
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 64764-550-90

90 TABLET, FILM COATED in 1 BOTTLE (64764-550-90)
Marketing Start Date2013-10-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 64764-550-09 [64764055009]

Brintellix TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA204447
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-10-02
Marketing End Date2019-08-15

NDC 64764-550-07 [64764055007]

Brintellix TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA204447
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-10-02
Marketing End Date2019-08-15

NDC 64764-550-90 [64764055090]

Brintellix TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA204447
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-10-02
Marketing End Date2019-08-15

NDC 64764-550-30 [64764055030]

Brintellix TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA204447
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-10-02
Marketing End Date2019-08-15

NDC 64764-550-77 [64764055077]

Brintellix TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA204447
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-10-02
Marketing End Date2019-08-15

Drug Details

Active Ingredients

IngredientStrength
VORTIOXETINE HYDROBROMIDE5 mg/1

OpenFDA Data

SPL SET ID:4b0700c9-b417-4c3a-b36f-de461e125bd3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1439844
  • 1439842
  • 1439840
  • 1439808
  • 1439829
  • 1439838
  • 1439810
  • 1439812
  • UPC Code
  • 0364764560300
  • 0364764580308
  • 0364764550301
  • 0364764570309
  • Medicade Reported Pricing

    64764055030 BRINTELLIX 5 MG TABLET

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Brintellix" or generic name "Vortioxetine"

    NDCBrand NameGeneric Name
    64764-550Brintellixvortioxetine
    64764-560Brintellixvortioxetine
    64764-570Brintellixvortioxetine
    64764-580Brintellixvortioxetine
    55154-0256Trintellixvortioxetine
    55154-0257Trintellixvortioxetine
    64764-720Trintellixvortioxetine
    64764-730Trintellixvortioxetine
    64764-750Trintellixvortioxetine

    Trademark Results [Brintellix]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    BRINTELLIX
    BRINTELLIX
    88844656 not registered Live/Pending
    H. Lundbeck A/S
    2020-03-23
    BRINTELLIX
    BRINTELLIX
    86463470 4873005 Live/Registered
    H. Lundbeck A/S
    2014-11-24
    BRINTELLIX
    BRINTELLIX
    86463444 4873004 Live/Registered
    H. Lundbeck A/S
    2014-11-24
    BRINTELLIX
    BRINTELLIX
    79389431 not registered Live/Pending
    H. Lundbeck A/S
    2023-11-23
    BRINTELLIX
    BRINTELLIX
    79114307 4420245 Live/Registered
    H. Lundbeck A/S
    2012-03-26

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.