🇺🇸
United States · US · US:50881-007_a32bcaac-6cd8-41be-8686-3e10268e0539
OPZELURA
Orange BookUNIISPLATC D11AH09
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerIncyte Corporation
CountryUS (United States)
ATC codeD11AH09
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc1150881007041 TUBE in 1 CARTON (50881-007-04) / 5 g in 1 TUBE
- ndc1150881007051 TUBE in 1 CARTON (50881-007-05) / 60 g in 1 TUBE
- ndc1150881007071 TUBE in 1 CARTON (50881-007-07) / 100 g in 1 TUBE
- ndc1150881007141 TUBE in 1 CARTON (50881-007-14) / 3 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
436LRU32H5
RUXOLITINIB PHOSPHATE
RxCUI 1193325
Orange Book
N215309
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "436LRU32H5",
"rxcui": "1193325",
"inchikey": "JFMWPOCYMYGEDM-XFULWGLBSA-N",
"display_name": "RUXOLITINIB PHOSPHATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "TOPICAL",
"spl_meta": {
"24da5509-6631-4795-9d42-273faecd08e7": {
"match": "brand_token",
"title": "OPZELURA (RUXOLITINIB) CREAM [INCYTE CORPORATION]",
"spl_version": "13",
"published_date": "2025-11-17"
}
},
"productid": "50881-007_a32bcaac-6cd8-41be-8686-3e10268e0539",
"productndc": "50881-007",
"dosage_form": "CREAM",
"orange_book": {
"appl_no": "215309",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 1.5% BASE",
"product_no": "001",
"approval_date": "Sep 21, 2021"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "RUXOLITINIB PHOSPHATE",
"proprietary_name": "OPZELURA",
"active_ingred_unit": "mg/g",
"application_number": "NDA215309",
"marketing_category": "NDA",
"nonproprietary_name": "ruxolitinib",
"start_marketing_date": "20210921",
"active_numerator_strength": "15"
}Related drugs
Other records sharing ATC code D11AH09.
Access this data programmatically
Query OPZELURA and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.