🇺🇸
United States · US · US:68382-520_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 · 6
- ndc116838252001100 TABLET, FILM COATED in 1 BOTTLE (68382-520-01)
- ndc116838252005500 TABLET, FILM COATED in 1 BOTTLE (68382-520-05)
- ndc11683825200630 TABLET, FILM COATED in 1 BOTTLE (68382-520-06)
- ndc1168382520101000 TABLET, FILM COATED in 1 BOTTLE (68382-520-10)
- ndc11683825201690 TABLET, FILM COATED in 1 BOTTLE (68382-520-16)
- ndc11683825207710 BLISTER PACK in 1 CARTON (68382-520-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-520-30)
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": "68382-520_f54f3f24-5d0f-44a1-a4ca-03950954826f",
"productndc": "68382-520",
"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": "20140115",
"active_numerator_strength": ".5"
}Related drugs
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