Skytrofa

UNIISPLATC H01AC09

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAscendis Pharma Endocrinology, Inc.

CountryUS (United States)

ATC codeH01AC09

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7336201301
4 BLISTER PACK in 1 CARTON (73362-013-01) / 1 CARTRIDGE in 1 BLISTER PACK (73362-013-02) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTRIDGE

Annotations

UNII (FDA Substance ID)

OP35X9610Y

LONAPEGSOMATROPIN

RxCUI 2569562

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "OP35X9610Y",
    "rxcui": "2569562",
    "inchikey": null,
    "display_name": "LONAPEGSOMATROPIN",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBCUTANEOUS",
  "spl_meta": {
    "9229f871-bc61-4ddc-8122-d126d40e36ac": {
      "match": "brand_token",
      "title": "SKYTROFA (LONAPEGSOMATROPIN-TCGD) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ASCENDIS PHARMA ENDOCRINOLOGY, INC.]",
      "spl_version": "11",
      "published_date": "2025-09-11"
    }
  },
  "productid": "73362-013_f0f1bf14-7ce1-4d9c-9b80-4da87d1496de",
  "productndc": "73362-013",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LONAPEGSOMATROPIN",
  "proprietary_name": "Skytrofa",
  "active_ingred_unit": "mg/1",
  "application_number": "BLA761177",
  "marketing_category": "BLA",
  "nonproprietary_name": "Lonapegsomatropin-tcgd",
  "start_marketing_date": "20250725",
  "active_numerator_strength": "1.4"
}

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