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United States · US · US:66215-201_f9cb16ee-d325-b331-e053-6394a90ab08c
Zavesca
Orange BookUNIIATC A16AX06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerActelion Pharmaceuticals US, Inc.
CountryUS (United States)
ATC codeA16AX06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1166215201906 BLISTER PACK in 1 CARTON (66215-201-90) / 15 CAPSULE in 1 BLISTER PACK (66215-201-15)
Annotations
UNII (FDA Substance ID)
ADN3S497AZ
MIGLUSTAT
RxCUI 402316
Orange Book
N021348
AB
Raw payload (JSON)
{
"unii": {
"unii": "ADN3S497AZ",
"rxcui": "402316",
"inchikey": "UQRORFVVSGFNRO-UTINFBMNSA-N",
"display_name": "MIGLUSTAT",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"productid": "66215-201_f9cb16ee-d325-b331-e053-6394a90ab08c",
"productndc": "66215-201",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "021348",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "100MG",
"product_no": "001",
"approval_date": "Jul 31, 2003"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MIGLUSTAT",
"proprietary_name": "Zavesca",
"active_ingred_unit": "mg/1",
"application_number": "NDA021348",
"marketing_category": "NDA",
"nonproprietary_name": "miglustat",
"start_marketing_date": "20030731",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code A16AX06.
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