🇺🇸
United States · US · US:68382-352_f54f3f24-5d0f-44a1-a4ca-03950954826f
sirolimus
Orange BookUNIISPLATC S01XA23
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeS01XA23
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc116838235201100 TABLET, FILM COATED in 1 BOTTLE (68382-352-01)
- ndc11683823527710 BLISTER PACK in 1 CARTON (68382-352-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-352-30)
Annotations
UNII (FDA Substance ID)
W36ZG6FT64
SIROLIMUS
RxCUI 35302
Orange Book
A201676
ABABAB
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": "68382-352_f54f3f24-5d0f-44a1-a4ca-03950954826f",
"productndc": "68382-352",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "201676",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "1MG",
"product_no": "001",
"approval_date": "Feb 15, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "2MG",
"product_no": "002",
"approval_date": "Feb 15, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.5MG",
"product_no": "003",
"approval_date": "Jan 8, 2014"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SIROLIMUS",
"proprietary_name": "sirolimus",
"active_ingred_unit": "mg/1",
"application_number": "ANDA201676",
"marketing_category": "ANDA",
"nonproprietary_name": "sirolimus",
"start_marketing_date": "20230216",
"active_numerator_strength": "2"
}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.