🇺🇸
United States · US · US:55111-654_f9a9d4b5-1c61-a2e6-5511-84b3f4f9b24b
Sirolimus
Orange BookUNIISPLATC S01XA23
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDr. Reddy's Laboratories Limited
CountryUS (United States)
ATC codeS01XA23
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc115511165401100 TABLET in 1 BOTTLE (55111-654-01)
- ndc11551116543030 TABLET in 1 BOTTLE (55111-654-30)
Annotations
UNII (FDA Substance ID)
W36ZG6FT64
SIROLIMUS
RxCUI 35302
Orange Book
A201578
ABAB
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": "55111-654_f9a9d4b5-1c61-a2e6-5511-84b3f4f9b24b",
"productndc": "55111-654",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "201578",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "1MG",
"product_no": "001",
"approval_date": "Oct 27, 2014"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "2MG",
"product_no": "002",
"approval_date": "Oct 27, 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": "ANDA201578",
"marketing_category": "ANDA",
"nonproprietary_name": "Sirolimus",
"start_marketing_date": "20141027",
"active_numerator_strength": "2"
}Related drugs
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