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United States · US · US:42799-709_462f6c9d-b8f1-3a76-e063-6294a90a2b50
Yargesa
Orange BookUNIISPLATC A16AX06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerEdenbridge Pharmaceuticals LLC.
CountryUS (United States)
ATC codeA16AX06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1142799709151 BLISTER PACK in 1 CARTON (42799-709-15) / 15 CAPSULE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
ADN3S497AZ
MIGLUSTAT
RxCUI 402316
Orange Book
A209821
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": {
"2b371dfe-e2b0-47fe-b677-a7bde7149f87": {
"match": "brand_token",
"title": "YARGESA (MIGLUSTAT) CAPSULE [EDENBRIDGE PHARMACEUTICALS LLC.]",
"spl_version": "5",
"published_date": "2025-12-19"
}
},
"productid": "42799-709_462f6c9d-b8f1-3a76-e063-6294a90a2b50",
"productndc": "42799-709",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "209821",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "001",
"approval_date": "Aug 6, 2020"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MIGLUSTAT",
"proprietary_name": "Yargesa",
"active_ingred_unit": "mg/1",
"application_number": "ANDA209821",
"marketing_category": "ANDA",
"nonproprietary_name": "Miglustat",
"start_marketing_date": "20200806",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code A16AX06.
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