NDC 68546-176 Austedo
Deutetrabenazine Kit - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
Product Characteristics
BLUE (C48333)
BROWN (C48332 - BEIGE)
SD;9
SD;12
Code Structure Chart
Product Details
What is NDC 68546-176?
What are the uses for Austedo?
Which are Austedo UNII Codes?
The UNII codes for the active ingredients in this product are:
- DEUTETRABENAZINE (UNII: P341G6W9NB)
- DEUTETRABENAZINE (UNII: P341G6W9NB) (Active Moiety)
Which are Austedo Inactive Ingredients UNII Codes?
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:
- AMMONIA (UNII: 5138Q19F1X)
- FERROSOFERRIC OXIDE (UNII: XM0M87F357)
- BUTYL ALCOHOL (UNII: 8PJ61P6TS3)
- BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
- BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
- MAGNESIUM STEARATE (UNII: 70097M6I30)
- MANNITOL (UNII: 3OWL53L36A)
- MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
- POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
- POLYSORBATE 80 (UNII: 6OZP39ZG8H)
- POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
- POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
- PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
- SHELLAC (UNII: 46N107B71O)
- TALC (UNII: 7SEV7J4R1U)
- TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
- FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
- FD&C RED NO. 40 (UNII: WZB9127XOA)
- POLYETHYLENE GLYCOL 2000000 (UNII: 5K3991GVWI)
- FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
- POVIDONE (UNII: FZ989GH94E)
What is the NDC to RxNorm Crosswalk for Austedo?
- RxCUI: 1876910 - deutetrabenazine 12 MG Oral Tablet
- RxCUI: 1876916 - Austedo 12 MG Oral Tablet
- RxCUI: 1876916 - deutetrabenazine 12 MG Oral Tablet [Austedo]
- RxCUI: 1876918 - deutetrabenazine 6 MG Oral Tablet
- RxCUI: 1876920 - Austedo 6 MG Oral Tablet
* Please review the disclaimer below.
Patient Education
Deutetrabenazine
Deutetrabenazine is used to treat chorea (sudden movements that you cannot control) caused by Huntington's disease (an inherited disease that causes the progressive breakdown of nerve cells in the brain). It is also used to treat tardive dyskinesia (uncontrollable movement of the face, tongue, or other body parts). Deutetrabenazine is in a class of medications called vesicular monoamine transporter 2 (VMAT2) inhibitors. It works by changing the activity of certain natural substances in the brain that affect nerves and muscles.
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* Please review the disclaimer below.
[1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
[3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.
[6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.
[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.
[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".