🇺🇸
United States · US · US:60505-6197_5fb6d644-aae8-0bcc-d9ce-170dff1c4b44
Sirolimus
Orange BookUNIISPLATC S01XA23
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerApotex Corp
CountryUS (United States)
ATC codeS01XA23
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1160505619721 BOTTLE, GLASS in 1 CARTON (60505-6197-2) / 60 mL in 1 BOTTLE, GLASS
Annotations
UNII (FDA Substance ID)
W36ZG6FT64
SIROLIMUS
RxCUI 35302
Orange Book
A211406
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": "60505-6197_5fb6d644-aae8-0bcc-d9ce-170dff1c4b44",
"productndc": "60505-6197",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "211406",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "1MG/ML",
"product_no": "001",
"approval_date": "Oct 22, 2019"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SIROLIMUS",
"proprietary_name": "Sirolimus",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA211406",
"marketing_category": "ANDA",
"nonproprietary_name": "SIROLIMUS",
"start_marketing_date": "20200520",
"active_numerator_strength": "1"
}Related drugs
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