🇺🇸
United States · US · US:80803-153_94544e08-d7c0-4154-aa40-46c5298c5528
FYARRO
Orange BookUNIISPLATC S01XA23
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAadi Bioscience, Inc.
CountryUS (United States)
ATC codeS01XA23
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1180803153501 VIAL, SINGLE-USE in 1 CARTON (80803-153-50) / 20 mL in 1 VIAL, SINGLE-USE
Annotations
UNII (FDA Substance ID)
W36ZG6FT64
SIROLIMUS
RxCUI 35302
Orange Book
N213312
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": "INTRAVENOUS",
"spl_meta": {
"0f9bb784-53e2-46f9-a65d-1c6c2a230eaf": {
"match": "brand_token",
"title": "FYARRO (SIROLIMUS) INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION [AADI BIOSCIENCE, INC.]",
"spl_version": "9",
"published_date": "2026-05-21"
}
},
"productid": "80803-153_94544e08-d7c0-4154-aa40-46c5298c5528",
"productndc": "80803-153",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION",
"orange_book": {
"appl_no": "213312",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "100MG/VIAL",
"product_no": "001",
"approval_date": "Nov 22, 2021"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SIROLIMUS",
"proprietary_name": "FYARRO",
"active_ingred_unit": "mg/mL",
"application_number": "NDA213312",
"marketing_category": "NDA",
"nonproprietary_name": "Sirolimus",
"start_marketing_date": "20211206",
"active_numerator_strength": "5"
}Related drugs
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