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United States · US · US:75626-001_413a060a-faf5-af00-e063-6394a90af847
LUPKYNIS
Orange BookUNIISPLATC L04AD03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurinia Pharma U.S., Inc.
CountryUS (United States)
ATC codeL04AD03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1175626001023 PACKET in 1 CARTON (75626-001-02) / 4 BLISTER PACK in 1 PACKET (75626-001-01) / 15 CAPSULE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
2PN063X6B1
VOCLOSPORIN
RxCUI 2475166
Orange Book
N213716
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "2PN063X6B1",
"rxcui": "2475166",
"inchikey": "BICRTLVBTLFLRD-PTWUADNWSA-N",
"display_name": "VOCLOSPORIN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"9f489295-1156-52c7-5fd0-5c4c52f9b813": {
"match": "brand_token",
"title": "LUPKYNIS (VOCLOSPORIN) CAPSULE [AURINIA PHARMA U.S., INC.]",
"spl_version": "11",
"published_date": "2025-11-17"
}
},
"productid": "75626-001_413a060a-faf5-af00-e063-6394a90af847",
"productndc": "75626-001",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "213716",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "7.9MG",
"product_no": "001",
"approval_date": "Jan 22, 2021"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "VOCLOSPORIN",
"proprietary_name": "LUPKYNIS",
"active_ingred_unit": "mg/1",
"application_number": "NDA213716",
"marketing_category": "NDA",
"nonproprietary_name": "Voclosporin",
"start_marketing_date": "20210122",
"active_numerator_strength": "7.9"
}Related drugs
Other records sharing ATC code L04AD03.
- ISLupkynisOtsuka Pharmaceutical Netherlands B.V.*
- 🇨🇭LupkynisOtsuka Pharmaceutical (Switzerland) GmbH
- DKLupkynisOtsuka Pharmaceutical Netherlands B.V.
- PLLupkynisOtsuka Pharmaceutical Netherlands B.V.
- NOLupkynisOtsuka Pharmaceutical Netherlands B.V.
- FILupkynisOtsuka Pharmaceutical Netherlands B.V.
- CZLUPKYNISOtsuka Pharmaceutical Netherlands B.V., Amsterdam
- CZLUPKYNISOtsuka Pharmaceutical Netherlands B.V., Amsterdam
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