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United States · US · US:80610-115_f310345f-118f-4366-92d8-40ed96ea318b
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 · 2
- ndc1180610115601 TUBE in 1 CARTON (80610-115-60) / 60 g in 1 TUBE
- ndc1180610115966 TUBE in 1 CARTON (80610-115-96) / 5 g in 1 TUBE (80610-115-05)
Annotations
UNII (FDA Substance ID)
0P6C6ZOP5U
ROFLUMILAST
RxCUI 1091836
Orange Book
N215985
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": "80610-115_f310345f-118f-4366-92d8-40ed96ea318b",
"productndc": "80610-115",
"dosage_form": "CREAM",
"orange_book": {
"appl_no": "215985",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "0.3%",
"product_no": "001",
"approval_date": "Jul 29, 2022"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "0.15%",
"product_no": "002",
"approval_date": "Jul 9, 2024"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "0.05%",
"product_no": "003",
"approval_date": "Oct 4, 2025"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ROFLUMILAST",
"proprietary_name": "ZORYVE",
"active_ingred_unit": "mg/g",
"application_number": "NDA215985",
"marketing_category": "NDA",
"nonproprietary_name": "roflumilast",
"start_marketing_date": "20240709",
"active_numerator_strength": "1.5"
}Related drugs
Other records sharing ATC code R03DX07.
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