austedo xr

Generic: deutetrabenazine

Labeler: teva neuroscience, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name austedo xr
Generic Name deutetrabenazine
Labeler teva neuroscience, inc.
Dosage Form KIT
Manufacturer
Teva Neuroscience, Inc.

Identifiers & Regulatory

Product NDC 68546-477
Product ID 68546-477_69071a25-792d-4eec-a12a-1bb30c8fc881
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA216354
Listing Expiration 2026-12-31
Marketing Start 2024-07-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68546477
Hyphenated Format 68546-477

Supplemental Identifiers

RxCUI
1876910 1876916 1876918 1876920 1876922 1876924 2281114 2281115 2281116 2281117 2541518 2541519 2541520 2630144 2630147 2630150 2630153 2630155 2630157 2630159 2630160 2683282 2683285 2683288 2683291 2683294 2683297 2683300 2683303 2686153 2686156 2686612 2686613
UPC
0368546172606 0368546170602 0368546171609
UNII
P341G6W9NB

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name austedo xr (source: ndc)
Generic Name deutetrabenazine (source: ndc)
Application Number NDA216354 (source: ndc)
Routes
oral
source: label

Resolved Composition

Strengths
  • 6 mg
  • 12 mg
  • 18 mg
  • 24 mg
  • 30 mg
  • 36 mg
  • 42 mg
  • 48 mg
  • 9 mg
source: label
Packaging
  • 1 KIT in 1 BLISTER PACK (68546-477-28) * 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-192-07) * 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-190-07) * 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-193-07) * 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-191-07)
  • 1 BLISTER PACK in 1 CARTON (68546-477-29) / 1 KIT in 1 BLISTER PACK * 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-192-07) * 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-190-07) * 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-193-07) * 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-191-07)
source: ndc

Packages (2)

68546-477-28 1 KIT in 1 BLISTER PACK (68546-477-28) * 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-192-07) * 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-190-07) * 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-193-07) * 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-191-07) 68546-477-29 1 BLISTER PACK in 1 CARTON (68546-477-29) / 1 KIT in 1 BLISTER PACK * 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-192-07) * 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-190-07) * 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-193-07) * 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-191-07)

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Austedo, AUSTEDO, AUSTEDO XR ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "69071a25-792d-4eec-a12a-1bb30c8fc881", "openfda": {"upc": ["0368546172606", "0368546170602", "0368546171609"], "unii": ["P341G6W9NB"], "rxcui": ["1876910", "1876916", "1876918", "1876920", "1876922", "1876924", "2281114", "2281115", "2281116", "2281117", "2541518", "2541519", "2541520", "2630144", "2630147", "2630150", "2630153", "2630155", "2630157", "2630159", "2630160", "2683282", "2683285", "2683288", "2683291", "2683294", "2683297", "2683300", "2683303", "2686153", "2686156", "2686612", "2686613"], "spl_set_id": ["7ea3c60a-45c7-44cc-afc2-d87fa53993c0"], "manufacturer_name": ["Teva Neuroscience, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "1 KIT in 1 BLISTER PACK (68546-477-28)  *  7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-192-07)  *  7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-190-07)  *  7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-193-07)  *  7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-191-07)", "package_ndc": "68546-477-28", "marketing_start_date": "20240701"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (68546-477-29)  / 1 KIT in 1 BLISTER PACK *  7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-192-07)  *  7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-190-07)  *  7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-193-07)  *  7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-191-07)", "package_ndc": "68546-477-29", "marketing_start_date": "20240701"}], "brand_name": "AUSTEDO XR", "product_id": "68546-477_69071a25-792d-4eec-a12a-1bb30c8fc881", "dosage_form": "KIT", "product_ndc": "68546-477", "generic_name": "deutetrabenazine", "labeler_name": "Teva Neuroscience, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AUSTEDO XR", "application_number": "NDA216354", "marketing_category": "NDA", "marketing_start_date": "20240701", "listing_expiration_date": "20261231"}