🇺🇸
United States · US · US:43975-310_589c114d-45f1-423a-8064-846060d968ce
MIGLUSTAT
Orange BookUNIISPLATC A16AX06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerANI Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeA16AX06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1143975310836 BLISTER PACK in 1 CARTON (43975-310-83) / 15 CAPSULE in 1 BLISTER PACK (43975-310-08)
Annotations
UNII (FDA Substance ID)
ADN3S497AZ
MIGLUSTAT
RxCUI 402316
Orange Book
A208342
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": "43975-310_589c114d-45f1-423a-8064-846060d968ce",
"productndc": "43975-310",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "208342",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG",
"product_no": "001",
"approval_date": "Apr 17, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MIGLUSTAT",
"proprietary_name": "MIGLUSTAT",
"active_ingred_unit": "mg/1",
"application_number": "ANDA208342",
"marketing_category": "ANDA",
"nonproprietary_name": "MIGLUSTAT",
"start_marketing_date": "20180417",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code A16AX06.
- 🇺🇸MiglustatZydus Pharmaceuticals USA Inc.
- 🇺🇸MiglustatCoTherix, Inc.
- 🇺🇸MiglustatNavinta LLC
- 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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