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United States · US · US:68546-176_69071a25-792d-4eec-a12a-1bb30c8fc881
AUSTEDO
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTeva Neuroscience, Inc.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168546176281 BLISTER PACK in 1 CARTON (68546-176-28) / 1 KIT in 1 BLISTER PACK
Annotations
Orange Book
N208082
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": null,
"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": "68546-176_69071a25-792d-4eec-a12a-1bb30c8fc881",
"productndc": "68546-176",
"dosage_form": "KIT",
"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": null,
"proprietary_name": "AUSTEDO",
"active_ingred_unit": null,
"application_number": "NDA208082",
"marketing_category": "NDA",
"nonproprietary_name": "deutetrabenazine",
"start_marketing_date": "20200201",
"active_numerator_strength": null
}Access this data programmatically
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