NDC 69452-117

TETRABENAZINE

Tetrabenazine

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

Product ID69452-117_1ec6b48d-337a-4802-b993-5358b3705bc1
NDC69452-117
Product TypeHuman Prescription Drug
Proprietary NameTETRABENAZINE
Generic NameTetrabenazine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-01-15
Marketing CategoryANDA / ANDA
Application NumberANDA208826
Labeler NameBionpharma 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 69452-117-21

112 TABLET in 1 BOTTLE (69452-117-21)
Marketing Start Date2018-01-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69452-117-21 [69452011721]

TETRABENAZINE TABLET
Marketing CategoryANDA
Application NumberANDA208826
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-01-15

Drug Details

Active Ingredients

IngredientStrength
TETRABENAZINE12.5 mg/1

OpenFDA Data

SPL SET ID:acf78d97-fca5-49aa-8683-6db7396da72f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 805464
  • 199592
  • UPC Code
  • 0369452117217
  • 0369452118214
  • 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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