NDC 42291-807

Tetrabenazine

Tetrabenazine

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

Product ID42291-807_6404aff5-b168-f642-e053-2a91aa0aadf5
NDC42291-807
Product TypeHuman Prescription Drug
Proprietary NameTetrabenazine
Generic NameTetrabenazine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2017-02-08
Marketing CategoryANDA / ANDA
Application NumberANDA207682
Labeler NameAvKARE, Inc.
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 Through2020-12-31

Packaging

NDC 42291-807-30

30 TABLET in 1 BOTTLE (42291-807-30)
Marketing Start Date2017-02-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42291-807-30 [42291080730]

Tetrabenazine TABLET
Marketing CategoryANDA
Application NumberANDA207682
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-02-08

Drug Details

Active Ingredients

IngredientStrength
TETRABENAZINE25 mg/1

OpenFDA Data

SPL SET ID:18909efa-de8a-42f1-a641-aa0319d71c35
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 805464
  • 199592
  • UPC Code
  • 0342291806306
  • 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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