NDC 67386-422

Xenazine

Tetrabenazine

Xenazine is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Lundbeck Pharmaceuticals Llc. The primary component is Tetrabenazine.

Product ID67386-422_31440675-0226-4477-9e4e-b438e684597f
NDC67386-422
Product TypeHuman Prescription Drug
Proprietary NameXenazine
Generic NameTetrabenazine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2008-11-24
Marketing CategoryNDA / NDA
Application NumberNDA021894
Labeler NameLundbeck Pharmaceuticals LLC
Substance NameTETRABENAZINE
Active Ingredient Strength25 mg/1
Pharm ClassesVesicular Monoamine Transporter 2 Inhibitor [EPC],Vesicular Monoamine Transporter 2 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 67386-422-01

112 TABLET in 1 BOTTLE (67386-422-01)
Marketing Start Date2008-11-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67386-422-01 [67386042201]

Xenazine TABLET
Marketing CategoryNDA
Application NumberNDA021894
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-11-24

Drug Details

Active Ingredients

IngredientStrength
TETRABENAZINE25 mg/1

OpenFDA Data

SPL SET ID:ac768bab-8afa-4446-bc7f-caeeffec0cda
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 805462
  • 805464
  • 805466
  • 199592

    • Pharmacological Class

    • Vesicular Monoamine Transporter 2 Inhibitor [EPC]
    • Vesicular Monoamine Transporter 2 Inhibitors [MoA]

    NDC Crossover Matching brand name "Xenazine" or generic name "Tetrabenazine"

    NDCBrand NameGeneric Name
    67386-421Xenazinetetrabenazine
    67386-422Xenazinetetrabenazine
    0054-0468TetrabenazineTetrabenazine
    0054-0469TetrabenazineTetrabenazine
    27241-176TetrabenazineTetrabenazine
    27241-177TetrabenazineTetrabenazine
    31722-821TetrabenazineTetrabenazine
    31722-822TetrabenazineTetrabenazine
    42291-806TetrabenazineTetrabenazine
    42291-807TetrabenazineTetrabenazine
    43598-394TetrabenazineTetrabenazine
    43598-395TetrabenazineTetrabenazine
    47335-179TetrabenazineTetrabenazine
    47335-277TetrabenazineTetrabenazine
    51224-425TETRABENAZINETETRABENAZINE
    51224-426TETRABENAZINETETRABENAZINE
    51407-480Tetrabenazinetetrabenazine
    51407-481Tetrabenazinetetrabenazine
    60505-3882Tetrabenazinetetrabenazine
    60505-3883Tetrabenazinetetrabenazine
    68180-408TetrabenazineTetrabenazine
    68180-409TetrabenazineTetrabenazine
    68682-421tetrabenazinetetrabenazine
    68682-422tetrabenazinetetrabenazine

    Trademark Results [Xenazine]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    XENAZINE
    XENAZINE
    76181171 2839404 Live/Registered
    BAUSCH HEALTH IRELAND LIMITED
    2000-12-13
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.