NDC 68546-170

Austedo

Deutetrabenazine

Austedo is a Oral Tablet, Coated in the Human Prescription Drug category. It is labeled and distributed by Teva Neuroscience, Inc.. The primary component is Deutetrabenazine.

Product ID68546-170_0de1abef-824f-4d54-9acf-30aa63d87a5a
NDC68546-170
Product TypeHuman Prescription Drug
Proprietary NameAustedo
Generic NameDeutetrabenazine
Dosage FormTablet, Coated
Route of AdministrationORAL
Marketing Start Date2017-04-12
Marketing CategoryNDA / NDA
Application NumberNDA208082
Labeler NameTeva Neuroscience, Inc.
Substance NameDEUTETRABENAZINE
Active Ingredient Strength6 mg/1
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 68546-170-60

60 TABLET, COATED in 1 BOTTLE (68546-170-60)
Marketing Start Date2017-04-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68546-170-60 [68546017060]

Austedo TABLET, COATED
Marketing CategoryNDA
Application NumberNDA208082
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-04-12

NDC 68546-170-66 [68546017066]

Austedo TABLET, COATED
Marketing CategoryNDA
Application NumberNDA208082
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-04-12

Drug Details

Active Ingredients

IngredientStrength
DEUTETRABENAZINE6 mg/1

OpenFDA Data

SPL SET ID:7ea3c60a-45c7-44cc-afc2-d87fa53993c0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1876920
  • 1876922
  • 1876924
  • 1876918
  • 1876916
  • 1876910
  • NDC Crossover Matching brand name "Austedo" or generic name "Deutetrabenazine"

    NDCBrand NameGeneric Name
    68546-170AustedoDeutetrabenazine
    68546-171AustedoDeutetrabenazine
    68546-172AustedoDeutetrabenazine
    68546-176AUSTEDOdeutetrabenazine
    68546-177AUSTEDOdeutetrabenazine

    Trademark Results [Austedo]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    AUSTEDO
    AUSTEDO
    86752573 5396839 Live/Registered
    Auspex Pharmaceuticals, Inc.
    2015-09-10
    AUSTEDO
    AUSTEDO
    86492765 5223589 Live/Registered
    Auspex Pharmaceuticals, Inc.
    2014-12-30
    AUSTEDO
    AUSTEDO
    86492763 5223588 Live/Registered
    Auspex Pharmaceuticals, Inc.
    2014-12-30

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