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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

  • ndc11
    7562600102
    3 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

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