NDC 51224-425

TETRABENAZINE

Tetrabenazine

TETRABENAZINE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Tagi Pharma, Inc.. The primary component is Tetrabenazine.

Product ID51224-425_5c40b7db-7ab7-4580-af2f-e1b36a82e2c3
NDC51224-425
Product TypeHuman Prescription Drug
Proprietary NameTETRABENAZINE
Generic NameTetrabenazine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2017-02-01
Marketing CategoryANDA / ANDA
Application NumberANDA207682
Labeler NameTAGI Pharma, Inc.
Substance NameTETRABENAZINE
Active Ingredient Strength13 mg/1
Pharm ClassesVesicular Monoamine Transporter 2 Inhibitor [EPC],Vesicular Monoamine Transporter 2 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 51224-425-10

112 TABLET in 1 BOTTLE (51224-425-10)
Marketing Start Date2017-02-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51224-425-10 [51224042510]

TETRABENAZINE TABLET
Marketing CategoryANDA
Application NumberANDA207682
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-02-01

Drug Details

Active Ingredients

IngredientStrength
TETRABENAZINE12.5 mg/1

OpenFDA Data

SPL SET ID:b041d7a5-a678-4f80-8d78-a42d3d003fbc
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 805464
  • 199592
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    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
    69452-118TETRABENAZINETETRABENAZINE
    69452-117TETRABENAZINETETRABENAZINE
    70436-101tetrabenazinetetrabenazine
    70436-102tetrabenazinetetrabenazine
    67386-421Xenazinetetrabenazine
    67386-422Xenazinetetrabenazine

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