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United States · US · US:71904-300_82a91fa0-6c38-452c-a5d0-2c2f7355f540
OPFOLDA
Orange BookUNIISPLATC A16AX06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAMICUS THERAPEUTICS US, LLC
CountryUS (United States)
ATC codeA16AX06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1171904300014 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (71904-300-01) / 1 CAPSULE in 1 BOTTLE, PLASTIC
- ndc11719043000224 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (71904-300-02) / 1 CAPSULE in 1 BOTTLE, PLASTIC
- ndc117190430003100 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (71904-300-03) / 1 CAPSULE in 1 BOTTLE, PLASTIC
Annotations
UNII (FDA Substance ID)
ADN3S497AZ
MIGLUSTAT
RxCUI 402316
Orange Book
N215211
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": {
"d7c38298-37db-5a80-e053-2995a90aee40": {
"match": "brand_token",
"title": "OPFOLDA (MIGLUSTAT) CAPSULE [AMICUS THERAPEUTICS US, LLC]",
"spl_version": "5",
"published_date": "2024-12-09"
}
},
"productid": "71904-300_82a91fa0-6c38-452c-a5d0-2c2f7355f540",
"productndc": "71904-300",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "215211",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "65MG",
"product_no": "001",
"approval_date": "Sep 28, 2023"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MIGLUSTAT",
"proprietary_name": "OPFOLDA",
"active_ingred_unit": "mg/1",
"application_number": "NDA215211",
"marketing_category": "NDA",
"nonproprietary_name": "miglustat",
"start_marketing_date": "20231011",
"active_numerator_strength": "65"
}Related drugs
Other records sharing ATC code A16AX06.
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