NDC 43598-394

Tetrabenazine

Tetrabenazine

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

Product ID43598-394_5e6a6ce2-1d7b-0e3f-6ae9-9bb1789be8e1
NDC43598-394
Product TypeHuman Prescription Drug
Proprietary NameTetrabenazine
Generic NameTetrabenazine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-01-08
Marketing CategoryANDA / ANDA
Application NumberANDA209284
Labeler NameDr. Reddys Laboratories 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 43598-394-05

500 TABLET in 1 BOTTLE (43598-394-05)
Marketing Start Date2018-01-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43598-394-05 [43598039405]

Tetrabenazine TABLET
Marketing CategoryANDA
Application NumberANDA209284
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-01-08

NDC 43598-394-67 [43598039467]

Tetrabenazine TABLET
Marketing CategoryANDA
Application NumberANDA209284
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-01-08

Drug Details

Active Ingredients

IngredientStrength
TETRABENAZINE12.5 mg/1

OpenFDA Data

SPL SET ID:ef5f9dd4-945f-ec27-518d-90996a7bd4b6
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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