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United States · US · US:67877-747_b6349068-caf8-4f40-959d-cb9f1b8dd2be
Sirolimus
Orange BookUNIISPLATC S01XA23
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAscend Laboratories, LLC
CountryUS (United States)
ATC codeS01XA23
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc116787774701100 TABLET, FILM COATED in 1 BOTTLE (67877-747-01)
- ndc116787774705500 TABLET, FILM COATED in 1 BOTTLE (67877-747-05)
- ndc11678777473030 TABLET, FILM COATED in 1 BOTTLE (67877-747-30)
- ndc116787774738100 BLISTER PACK in 1 CARTON (67877-747-38) / 10 TABLET, FILM COATED in 1 BLISTER PACK (67877-747-33)
Annotations
UNII (FDA Substance ID)
W36ZG6FT64
SIROLIMUS
RxCUI 35302
Orange Book
A214753
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": "67877-747_b6349068-caf8-4f40-959d-cb9f1b8dd2be",
"productndc": "67877-747",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "214753",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.5MG",
"product_no": "001",
"approval_date": "Mar 12, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "1MG",
"product_no": "002",
"approval_date": "Mar 12, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "2MG",
"product_no": "003",
"approval_date": "Mar 12, 2021"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SIROLIMUS",
"proprietary_name": "Sirolimus",
"active_ingred_unit": "mg/1",
"application_number": "ANDA214753",
"marketing_category": "ANDA",
"nonproprietary_name": "Sirolimus",
"start_marketing_date": "20210313",
"active_numerator_strength": "1"
}Related drugs
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