NDC 68682-421

tetrabenazine

Tetrabenazine

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

Product ID68682-421_3665f36b-e54c-4442-ae3e-913b156f1fd1
NDC68682-421
Product TypeHuman Prescription Drug
Proprietary Nametetrabenazine
Generic NameTetrabenazine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2015-07-20
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA021894
Labeler NameOceanside Pharmaceuticals
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 68682-421-12

112 TABLET in 1 BOTTLE (68682-421-12)
Marketing Start Date2015-07-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68682-421-12 [68682042112]

tetrabenazine TABLET
Marketing CategoryNDA authorized generic
Application NumberNDA021894
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-07-20

Drug Details

Active Ingredients

IngredientStrength
TETRABENAZINE12.5 mg/1

OpenFDA Data

SPL SET ID:5867189c-17bd-4e70-a079-c4730f9950d1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 805464
  • 199592
  • 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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