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United States · US · US:50222-280_01c060c1-bd52-44ba-b2f4-e033279ed354

Anzupgo

Orange BookUNIISPLATC D11AH11

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerLEO Pharma, Inc
CountryUS (United States)
ATC codeD11AH11
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    5022228030
    1 TUBE in 1 CARTON (50222-280-30) / 30 g in 1 TUBE
  • ndc11
    5022228091
    1 TUBE in 1 CARTON (50222-280-91) / 15 g in 1 TUBE
  • ndc11
    5022228099
    1 TUBE in 1 CARTON (50222-280-99) / 5 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
9L0Q8KK220
DELGOCITINIB
Orange Book
N219155
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "9L0Q8KK220",
    "rxcui": null,
    "inchikey": "LOWWYYZBZNSPDT-ZBEGNZNMSA-N",
    "display_name": "DELGOCITINIB",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "a59bf36e-6f04-4b47-b385-8040c95f040c": {
      "match": "brand_token",
      "title": "ANZUPGO (DELGOCITINIB) CREAM [LEO PHARMA, INC]",
      "spl_version": "4",
      "published_date": "2025-09-05"
    }
  },
  "productid": "50222-280_01c060c1-bd52-44ba-b2f4-e033279ed354",
  "productndc": "50222-280",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "219155",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "2%",
        "product_no": "001",
        "approval_date": "Jul 23, 2025"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DELGOCITINIB",
  "proprietary_name": "Anzupgo",
  "active_ingred_unit": "mg/g",
  "application_number": "NDA219155",
  "marketing_category": "NDA",
  "nonproprietary_name": "delgocitinib",
  "start_marketing_date": "20250724",
  "active_numerator_strength": "20"
}

Related drugs

Other records sharing ATC code D11AH11.

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