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United States · US · US:16110-391_89dd936d-4a69-4c60-b743-dfefb589ec1a
Klisyri
Orange BookUNIISPLATC D06BX03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAlmirall, LLC
CountryUS (United States)
ATC codeD06BX03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1116110391055 PACKET in 1 CARTON (16110-391-05) / .25 g in 1 PACKET
- ndc1116110391555 PACKET in 1 CARTON (16110-391-55) / .35 g in 1 PACKET
Annotations
UNII (FDA Substance ID)
4V9848RS5G
TIRBANIBULIN
RxCUI 2471078
Orange Book
N213189
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "4V9848RS5G",
"rxcui": "2471078",
"inchikey": "HUNGUWOZPQBXGX-UHFFFAOYSA-N",
"display_name": "TIRBANIBULIN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "TOPICAL",
"spl_meta": {
"589c8de8-b773-4d47-b60c-48471806cccc": {
"match": "brand_token",
"title": "KLISYRI (TIRBANIBULIN) OINTMENT [ALMIRALL, LLC]",
"spl_version": "12",
"published_date": "2024-11-11"
}
},
"productid": "16110-391_89dd936d-4a69-4c60-b743-dfefb589ec1a",
"productndc": "16110-391",
"dosage_form": "OINTMENT",
"orange_book": {
"appl_no": "213189",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "1%",
"product_no": "001",
"approval_date": "Dec 14, 2020"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TIRBANIBULIN",
"proprietary_name": "Klisyri",
"active_ingred_unit": "mg/g",
"application_number": "NDA213189",
"marketing_category": "NDA",
"nonproprietary_name": "tirbanibulin",
"start_marketing_date": "20201214",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code D06BX03.
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