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United States · US · US:73372-0116_5192f26d-d5e7-ce03-e063-6294a90a3ea2

SCENESSE

Orange BookUNIISPLATC D02BB02

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

Identification

ManufacturerCLINUVEL INC.
CountryUS (United States)
ATC codeD02BB02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7337201161
    1 VIAL, GLASS in 1 CARTON (73372-0116-1) / 1 mg in 1 VIAL, GLASS

Annotations

UNII (FDA Substance ID)
QW68W3J66U
AFAMELANOTIDE
RxCUI 2262250
Orange Book
N210797
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "QW68W3J66U",
    "rxcui": "2262250",
    "inchikey": "UAHFGYDRQSXQEB-LEBBXHLNSA-N",
    "display_name": "AFAMELANOTIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBCUTANEOUS",
  "spl_meta": {
    "94f53286-11dd-7fbb-e053-2a95a90a7c48": {
      "match": "brand_token",
      "title": "SCENESSE (AFAMELANOTIDE) IMPLANT [CLINUVEL INC.]",
      "spl_version": "11",
      "published_date": "2026-05-13"
    }
  },
  "productid": "73372-0116_5192f26d-d5e7-ce03-e063-6294a90a3ea2",
  "productndc": "73372-0116",
  "dosage_form": "IMPLANT",
  "orange_book": {
    "appl_no": "210797",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "16MG",
        "product_no": "001",
        "approval_date": "Oct 8, 2019"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AFAMELANOTIDE",
  "proprietary_name": "SCENESSE",
  "active_ingred_unit": "mg/16mg",
  "application_number": "NDA210797",
  "marketing_category": "NDA",
  "nonproprietary_name": "afamelanotide",
  "start_marketing_date": "20191231",
  "active_numerator_strength": "16"
}

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