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 ID: 68546-170_0de1abef-824f-4d54-9acf-30aa63d87a5a
• NDC: 68546-170
• Product Type: Human Prescription Drug
• Proprietary Name: Austedo
• Generic Name: Deutetrabenazine
• Dosage Form: Tablet, Coated
• Route of Administration: ORAL
• Marketing Start Date: 2017-04-12
• Marketing Category: NDA / NDA
• Application Number: NDA208082
• Labeler Name: Teva Neuroscience, Inc.
• Substance Name: DEUTETRABENAZINE
• Active Ingredient Strength: 6 mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 68546-170-60

60 TABLET, COATED in 1 BOTTLE (68546-170-60)

• Marketing Start Date: 2017-04-12
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68546-170-60 [68546017060]

Austedo TABLET, COATED

• Marketing Category: NDA
• Application Number: NDA208082
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-04-12

NDC 68546-170-66 [68546017066]

Austedo TABLET, COATED

• Marketing Category: NDA
• Application Number: NDA208082
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-04-12

Drug Details

Active Ingredients

Ingredient	Strength
DEUTETRABENAZINE	6 mg/1

OpenFDA Data

• SPL SET ID: 7ea3c60a-45c7-44cc-afc2-d87fa53993c0
• Manufacturer:
  • Teva Neuroscience, Inc.
• UNII:
  • P341G6W9NB
• RxNorm Concept Unique ID - RxCUI:
  • 1876920
  • 1876922
  • 1876924
  • 1876918
  • 1876916
  • 1876910

NDC Crossover Matching brand name "Austedo" or generic name "Deutetrabenazine"

NDC	Brand Name	Generic Name
68546-170	Austedo	Deutetrabenazine
68546-171	Austedo	Deutetrabenazine
68546-172	Austedo	Deutetrabenazine
68546-176	AUSTEDO	deutetrabenazine
68546-177	AUSTEDO	deutetrabenazine