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United States · US · US:73683-101_3cf7f2ef-f144-0632-e063-6394a90a9b9c
HYFTOR
Orange BookUNIISPLATC S01XA23
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNobelpharma America, LLC
CountryUS (United States)
ATC codeS01XA23
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1173683101101 TUBE in 1 CARTON (73683-101-10) / 10 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
W36ZG6FT64
SIROLIMUS
RxCUI 35302
Orange Book
N213478
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "W36ZG6FT64",
"rxcui": "35302",
"inchikey": "QFJCIRLUMZQUOT-HPLJOQBZSA-N",
"display_name": "SIROLIMUS",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "TOPICAL",
"spl_meta": {
"edb3ea90-5adc-48ec-99f5-ab963e302f18": {
"match": "brand_token",
"title": "HYFTOR (SIROLIMUS) GEL [NOBELPHARMA AMERICA, LLC]",
"spl_version": "10",
"published_date": "2025-08-25"
}
},
"productid": "73683-101_3cf7f2ef-f144-0632-e063-6394a90a9b9c",
"productndc": "73683-101",
"dosage_form": "GEL",
"orange_book": {
"appl_no": "213478",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "0.2%",
"product_no": "001",
"approval_date": "Mar 22, 2022"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SIROLIMUS",
"proprietary_name": "HYFTOR",
"active_ingred_unit": "mg/g",
"application_number": "NDA213478",
"marketing_category": "NDA",
"nonproprietary_name": "sirolimus",
"start_marketing_date": "20220323",
"active_numerator_strength": "2"
}Related drugs
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