🇺🇸
United States · US · US:68546-172_69071a25-792d-4eec-a12a-1bb30c8fc881
Austedo
Orange BookUNIISPLATC N07XX16
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTeva Neuroscience, Inc.
CountryUS (United States)
ATC codeN07XX16
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11685461726060 TABLET, COATED in 1 BOTTLE (68546-172-60)
Annotations
UNII (FDA Substance ID)
P341G6W9NB
DEUTETRABENAZINE
RxCUI 1876905
Orange Book
N208082
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "P341G6W9NB",
"rxcui": "1876905",
"inchikey": "MKJIEFSOBYUXJB-WEZHFFAMSA-N;MKJIEFSOBYUXJB-VFJJUKLQSA-N",
"display_name": "DEUTETRABENAZINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"7ea3c60a-45c7-44cc-afc2-d87fa53993c0": {
"match": "brand_token",
"title": "AUSTEDO (DEUTETRABENAZINE) TABLET, COATED AUSTEDO (DEUTETRABENAZINE) KIT AUSTEDO XR (DEUTETRABENAZINE) TABLET, FILM COATED, EXTENDED RELEASE [TEVA NEUROSCIENCE, INC.]",
"spl_version": "35",
"published_date": "2025-03-24"
}
},
"productid": "68546-172_69071a25-792d-4eec-a12a-1bb30c8fc881",
"productndc": "68546-172",
"dosage_form": "TABLET, COATED",
"orange_book": {
"appl_no": "208082",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "6MG",
"product_no": "001",
"approval_date": "Apr 3, 2017"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "9MG",
"product_no": "002",
"approval_date": "Apr 3, 2017"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "12MG",
"product_no": "003",
"approval_date": "Apr 3, 2017"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DEUTETRABENAZINE",
"proprietary_name": "Austedo",
"active_ingred_unit": "mg/1",
"application_number": "NDA208082",
"marketing_category": "NDA",
"nonproprietary_name": "Deutetrabenazine",
"start_marketing_date": "20170412",
"active_numerator_strength": "12"
}Related drugs
Other records sharing ATC code N07XX16.
Access this data programmatically
Query Austedo and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.