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United States · US · US:42747-203_59579885-f5a8-41ba-bfc7-5e3adcc1cbce

CRYSVITA

UNIISPLATC M05BX05

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

Identification

ManufacturerKyowa Kirin, Inc.
CountryUS (United States)
ATC codeM05BX05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4274720301
    1 mL in 1 VIAL, SINGLE-USE (42747-203-01)

Annotations

UNII (FDA Substance ID)
G9WJT6RD29
BUROSUMAB
RxCUI 2043855
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "G9WJT6RD29",
    "rxcui": "2043855",
    "inchikey": null,
    "display_name": "BUROSUMAB",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBCUTANEOUS",
  "spl_meta": {
    "102f96a0-6e3a-4fc1-b204-34d604683af6": {
      "match": "brand_token",
      "title": "CRYSVITA (BUROSUMAB) INJECTION [KYOWA KIRIN, INC.]",
      "spl_version": "5",
      "published_date": "2025-09-12"
    }
  },
  "productid": "42747-203_59579885-f5a8-41ba-bfc7-5e3adcc1cbce",
  "productndc": "42747-203",
  "dosage_form": "INJECTION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BUROSUMAB",
  "proprietary_name": "CRYSVITA",
  "active_ingred_unit": "mg/mL",
  "application_number": "BLA761068",
  "marketing_category": "BLA",
  "nonproprietary_name": "Burosumab",
  "start_marketing_date": "20180418",
  "active_numerator_strength": "20"
}

Related drugs

Other records sharing ATC code M05BX05.

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