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United States · US · US:76431-310_59bc2507-59e9-48c0-8c87-f65bb0f32258
FILSUVEZ
Orange BookUNIISPLATC D03AX13
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmryt Pharmaceuticals DAC
CountryUS (United States)
ATC codeD03AX13
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1176431310011 TUBE in 1 CARTON (76431-310-01) / 23.4 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
BX09B0RQR0
BIRCH TRITERPENES
Orange Book
N215064
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "BX09B0RQR0",
"rxcui": null,
"inchikey": null,
"display_name": "BIRCH TRITERPENES",
"substance_type": "specifiedSubstanceG1",
"ingredient_type": "SPECIFIED SUBSTANCE"
},
"route": "TOPICAL",
"spl_meta": {
"da793f2d-0a3d-4792-8c22-982f9f8cdd97": {
"match": "brand_token",
"title": "FILSUVEZ (BIRCH TRITERPENES) GEL [AMRYT PHARMACEUTICALS DAC]",
"spl_version": "9",
"published_date": "2026-01-26"
}
},
"productid": "76431-310_59bc2507-59e9-48c0-8c87-f65bb0f32258",
"productndc": "76431-310",
"dosage_form": "GEL",
"orange_book": {
"appl_no": "215064",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "10%",
"product_no": "001",
"approval_date": "Dec 18, 2023"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BIRCH TRITERPENES",
"proprietary_name": "FILSUVEZ",
"active_ingred_unit": "mg/g",
"application_number": "NDA215064",
"marketing_category": "NDA",
"nonproprietary_name": "birch triterpenes",
"start_marketing_date": "20240222",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code D03AX13.
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