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United States · US · US:72162-2641_71b9e046-12b4-4224-ab7a-ae65b34b5c1c
sirolimus
Orange BookUNIISPLATC S01XA23
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeS01XA23
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1172162264161 BOTTLE, GLASS in 1 CARTON (72162-2641-6) / 60 mL in 1 BOTTLE, GLASS
Annotations
UNII (FDA Substance ID)
W36ZG6FT64
SIROLIMUS
RxCUI 35302
Orange Book
A216728
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": "72162-2641_71b9e046-12b4-4224-ab7a-ae65b34b5c1c",
"productndc": "72162-2641",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "216728",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "1MG/ML",
"product_no": "001",
"approval_date": "Jan 19, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SIROLIMUS",
"proprietary_name": "sirolimus",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA216728",
"marketing_category": "ANDA",
"nonproprietary_name": "sirolimus",
"start_marketing_date": "20230119",
"active_numerator_strength": "1"
}Related drugs
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