🇺🇸
United States · US · US:68475-204_94491d95-3cdd-45cd-b94c-a0d4982618cc
Miglustat
Orange BookUNIISPLATC A16AX06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNavinta LLC
CountryUS (United States)
ATC codeA16AX06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1168475204026 BLISTER PACK in 1 CARTON (68475-204-02) / 15 CAPSULE in 1 BLISTER PACK (68475-204-01)
- ndc1168475204044 BLISTER PACK in 1 CARTON (68475-204-04) / 21 CAPSULE in 1 BLISTER PACK (68475-204-03)
Annotations
UNII (FDA Substance ID)
ADN3S497AZ
MIGLUSTAT
RxCUI 402316
Orange Book
A219111
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "ADN3S497AZ",
"rxcui": "402316",
"inchikey": "UQRORFVVSGFNRO-UTINFBMNSA-N",
"display_name": "MIGLUSTAT",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"aa9a3ab6-2376-4b52-9e54-15dc87f25260": {
"match": "brand_token",
"title": "MIGLUSTAT CAPSULE [NAVINTA LLC]",
"spl_version": "3",
"published_date": "2026-01-01"
}
},
"productid": "68475-204_94491d95-3cdd-45cd-b94c-a0d4982618cc",
"productndc": "68475-204",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "219111",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "001",
"approval_date": "Mar 14, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MIGLUSTAT",
"proprietary_name": "Miglustat",
"active_ingred_unit": "mg/1",
"application_number": "ANDA219111",
"marketing_category": "ANDA",
"nonproprietary_name": "Miglustat",
"start_marketing_date": "20250507",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code A16AX06.
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- DKMiglustat "Bluefish"Bluefish Pharmaceuticals AB
- DKMiglustat "Dipharma"Dipharma Arzneimittel GmbH
- DKMiglustat "Waymade"Waymade B.V.
- GBMiglustat 100mg capsulesAccord-UK Ltd
- GBMiglustat 100mg capsulesA A H Pharmaceuticals Ltd
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