🇺🇸
United States · US · US:59762-1205_1501a154-5d23-4ff0-a6ef-31715dcb2282
Sirolimus
Orange BookUNIISPLATC S01XA23
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMylan Pharmaceuticals Inc.
CountryUS (United States)
ATC codeS01XA23
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1159762120561 CARTON in 1 KIT (59762-1205-6) / 1 BOTTLE, GLASS in 1 CARTON (59762-1205-4) / 60 mL in 1 BOTTLE, GLASS
Annotations
UNII (FDA Substance ID)
W36ZG6FT64
SIROLIMUS
RxCUI 35302
Orange Book
N021083
AA
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": "ORAL",
"spl_meta": {
"ad39eb60-1fa0-4722-8ba1-523194921c2a": {
"match": "brand_token",
"title": "SIROLIMUS TABLET, FILM COATED [NORTHSTAR RX LLC]",
"spl_version": "4",
"published_date": "2026-05-13"
}
},
"productid": "59762-1205_1501a154-5d23-4ff0-a6ef-31715dcb2282",
"productndc": "59762-1205",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "021083",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AA",
"strength": "1MG/ML",
"product_no": "001",
"approval_date": "Sep 15, 1999"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SIROLIMUS",
"proprietary_name": "Sirolimus",
"active_ingred_unit": "mg/mL",
"application_number": "NDA021083",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "sirolimus",
"start_marketing_date": "20190722",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code S01XA23.
- 🇺🇸FYARROAadi Bioscience, Inc.
- 🇺🇸HYFTORNobelpharma America, LLC
- GBHyftor 2mg/g gelPlusultra Pharma UK Ltd
- 🇪🇸RAPAMUNE 0,5 mg COMPRIMIDOS RECUBIERTOSPfizer Europe Ma Eeig
- 🇫🇷RAPAMUNE 0,5 mg, comprimé enrobéPFIZER EUROPE MA EEIG (BELGIQUE)
- GBRapamune 0.5mg tabletsPfizer Ltd
- 🇪🇸RAPAMUNE 1 mg COMPRIMIDOS RECUBIERTOSPfizer Europe Ma Eeig
- 🇫🇷RAPAMUNE 1 mg, comprimé enrobéPFIZER EUROPE MA EEIG (BELGIQUE)
Access this data programmatically
Query Sirolimus and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.