TEZSPIRE

UNIISPLATC R03DX11

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

Identification

ManufacturerAmgen Inc

CountryUS (United States)

ATC codeR03DX11

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
5551312301
1 CARTRIDGE in 1 CARTON (55513-123-01) / 1.91 mL in 1 CARTRIDGE
ndc11
5551312396
1 CARTRIDGE in 1 CARTON (55513-123-96) / 1.91 mL in 1 CARTRIDGE

Annotations

UNII (FDA Substance ID)

RJ1IW3B4QX

TEZEPELUMAB

RxCUI 2587789

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "RJ1IW3B4QX",
    "rxcui": "2587789",
    "inchikey": null,
    "display_name": "TEZEPELUMAB",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBCUTANEOUS",
  "spl_meta": {
    "60f0aa03-ad25-4d48-80ce-7fcfa76f325f": {
      "match": "brand_token",
      "title": "TEZSPIRE (TEZEPELUMAB-EKKO) INJECTION, SOLUTION [AMGEN INC]",
      "spl_version": "15",
      "published_date": "2025-11-18"
    }
  },
  "productid": "55513-123_7aa761f9-01a0-48d3-a553-fa93fee5f243",
  "productndc": "55513-123",
  "dosage_form": "INJECTION, SOLUTION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TEZEPELUMAB",
  "proprietary_name": "TEZSPIRE",
  "active_ingred_unit": "mg/1.9mL",
  "application_number": "BLA761224",
  "marketing_category": "BLA",
  "nonproprietary_name": "tezepelumab-ekko",
  "start_marketing_date": "20211217",
  "active_numerator_strength": "210"
}

Related drugs

Other records sharing ATC code R03DX11.

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