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United States · US · US:70482-085_41c15d67-44b5-5c87-e063-6294a90adcc8
GOCOVRI
In shortageOrange BookUNIISPLATC N04BB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAdamas Pharma, LLC
CountryUS (United States)
ATC codeN04BB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11704820852121 CAPSULE, COATED PELLETS in 1 BOTTLE (70482-085-21)
- ndc11704820856060 CAPSULE, COATED PELLETS in 1 BOTTLE (70482-085-60)
- ndc11704820856160 CAPSULE, COATED PELLETS in 1 BOTTLE (70482-085-61)
Annotations
UNII (FDA Substance ID)
BF4C9Z1J53
AMANTADINE
RxCUI 620
Orange Book
N208944
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Amantadine Hydrochloride Capsule
Raw payload (JSON)
{
"unii": {
"unii": "BF4C9Z1J53",
"rxcui": "620",
"inchikey": "DKNWSYNQZKUICI-UHFFFAOYSA-N",
"display_name": "AMANTADINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"2bee0631-0028-1314-e063-6394a90aaaed": {
"match": "brand_token",
"title": "GOCOVRI (AMANTADINE) CAPSULE, COATED PELLETS [SUPERNUS PHARMACEUTICALS]",
"spl_version": "6",
"published_date": "2026-02-18"
}
},
"productid": "70482-085_41c15d67-44b5-5c87-e063-6294a90adcc8",
"productndc": "70482-085",
"dosage_form": "CAPSULE, COATED PELLETS",
"orange_book": {
"appl_no": "208944",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 68.5MG BASE",
"product_no": "001",
"approval_date": "Aug 24, 2017"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 137MG BASE",
"product_no": "002",
"approval_date": "Aug 24, 2017"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "AMANTADINE",
"shortage_reason": "Amantadine Hydrochloride Capsule",
"shortage_status": "current",
"proprietary_name": "GOCOVRI",
"active_ingred_unit": "mg/1",
"application_number": "NDA208944",
"marketing_category": "NDA",
"nonproprietary_name": "AMANTADINE",
"start_marketing_date": "20170824",
"active_numerator_strength": "68.5"
}Related drugs
Other records sharing ATC code N04BB01.
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