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United States · US · US:80610-430_e16c73c6-8f2a-470b-9504-83b183e9df16
ZORYVE
Orange BookUNIISPLATC R03DX07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerArcutis Biotherapeutics, Inc.
CountryUS (United States)
ATC codeR03DX07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1180610430601 CAN in 1 CARTON (80610-430-60) / 60 g in 1 CAN
Annotations
UNII (FDA Substance ID)
0P6C6ZOP5U
ROFLUMILAST
RxCUI 1091836
Orange Book
N217242
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "0P6C6ZOP5U",
"rxcui": "1091836",
"inchikey": "MNDBXUUTURYVHR-UHFFFAOYSA-N",
"display_name": "ROFLUMILAST",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "TOPICAL",
"spl_meta": {
"ec1bb0d1-f38a-4080-831a-68791d1d1fdb": {
"match": "brand_token",
"title": "ZORYVE (ROFLUMILAST) CREAM [ARCUTIS BIOTHERAPEUTICS, INC.]",
"spl_version": "12",
"published_date": "2026-02-02"
}
},
"productid": "80610-430_e16c73c6-8f2a-470b-9504-83b183e9df16",
"productndc": "80610-430",
"dosage_form": "AEROSOL, FOAM",
"orange_book": {
"appl_no": "217242",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "0.3%",
"product_no": "001",
"approval_date": "Dec 15, 2023"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ROFLUMILAST",
"proprietary_name": "ZORYVE",
"active_ingred_unit": "mg/g",
"application_number": "NDA217242",
"marketing_category": "NDA",
"nonproprietary_name": "roflumilast",
"start_marketing_date": "20231215",
"active_numerator_strength": "3"
}Related drugs
Other records sharing ATC code R03DX07.
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