TEPEZZA

UNIISPLATC L04AG13

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

Identification

ManufacturerHorizon Therapeutics USA, Inc.

CountryUS (United States)

ATC codeL04AG13

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7598713015
1 VIAL, SINGLE-DOSE in 1 CARTON (75987-130-15) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)

Y64GQ0KC0A

TEPROTUMUMAB

RxCUI 2274803

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "Y64GQ0KC0A",
    "rxcui": "2274803",
    "inchikey": null,
    "display_name": "TEPROTUMUMAB",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "3e6c54a1-cefd-4a5b-a855-ab9f268b6cce": {
      "match": "brand_token",
      "title": "TEPEZZA (TEPROTUMUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HORIZON THERAPEUTICS USA, INC.]",
      "spl_version": "17",
      "published_date": "2025-11-17"
    }
  },
  "productid": "75987-130_ade7436a-343e-43c8-964d-5aca91c4feaa",
  "productndc": "75987-130",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TEPROTUMUMAB",
  "proprietary_name": "TEPEZZA",
  "active_ingred_unit": "mg/1",
  "application_number": "BLA761143",
  "marketing_category": "BLA",
  "nonproprietary_name": "teprotumumab",
  "start_marketing_date": "20200121",
  "active_numerator_strength": "500"
}

Related drugs

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