NDC 0054-0468

Tetrabenazine

Tetrabenazine

Tetrabenazine is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Hikma Pharmaceuticals Usa Inc.. The primary component is Tetrabenazine.

Product ID0054-0468_64a3ab43-4006-4dbc-9feb-3ecd3de50bb2
NDC0054-0468
Product TypeHuman Prescription Drug
Proprietary NameTetrabenazine
Generic NameTetrabenazine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-06-28
Marketing CategoryANDA / ANDA
Application NumberANDA209739
Labeler NameHikma Pharmaceuticals USA 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 0054-0468-23

112 TABLET in 1 BOTTLE (0054-0468-23)
Marketing Start Date2019-09-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0054-0468-23 [00054046823]

Tetrabenazine TABLET
Marketing CategoryANDA
Application NumberANDA209739
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-09-19

Drug Details

Active Ingredients

IngredientStrength
TETRABENAZINE12.5 mg/1

OpenFDA Data

SPL SET ID:cb248fcc-56a4-4339-8e97-6dbca8405648
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 805464
  • 199592
    • UPC Code
  • 0300540469238

    • Pharmacological Class

    • 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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