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United States · US · US:10122-210_8b236f4c-7654-49fe-bca9-ab947b72a1fd

Myalept

UNIISPLATC A16AA07

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

Identification

ManufacturerChiesi USA, Inc.
CountryUS (United States)
ATC codeA16AA07
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    1012221002
    1 VIAL, GLASS in 1 CARTON (10122-210-02) / 2.2 mL in 1 VIAL, GLASS

Annotations

UNII (FDA Substance ID)
TL60C27RLH
METRELEPTIN
RxCUI 1491625
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "TL60C27RLH",
    "rxcui": "1491625",
    "inchikey": null,
    "display_name": "METRELEPTIN",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBCUTANEOUS",
  "spl_meta": {
    "d3b50bbd-140b-425c-b5ec-d4682aad62bc": {
      "match": "brand_token",
      "title": "MYALEPT (METRELEPTIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CHIESI USA, INC.]",
      "spl_version": "18",
      "published_date": "2025-03-10"
    }
  },
  "productid": "10122-210_8b236f4c-7654-49fe-bca9-ab947b72a1fd",
  "productndc": "10122-210",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METRELEPTIN",
  "proprietary_name": "Myalept",
  "active_ingred_unit": "mg/2.2mL",
  "application_number": "BLA125390",
  "marketing_category": "BLA",
  "nonproprietary_name": "metreleptin",
  "start_marketing_date": "20150305",
  "active_numerator_strength": "11.3"
}

Related drugs

Other records sharing ATC code A16AA07.

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