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United States · US · US:50474-980_48d5f5c1-c45c-cb63-e063-6394a90a31c8

RYSTIGGO

UNIISPLATC L04AG16

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

Identification

ManufacturerUCB, Inc.
CountryUS (United States)
ATC codeL04AG16
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5047498079
    1 VIAL, GLASS in 1 CARTON (50474-980-79) / 2 mL in 1 VIAL, GLASS

Annotations

UNII (FDA Substance ID)
P7186074QC
ROZANOLIXIZUMAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "P7186074QC",
    "rxcui": null,
    "inchikey": null,
    "display_name": "ROZANOLIXIZUMAB",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBCUTANEOUS",
  "spl_meta": {
    "3c0eb8c2-c042-4954-b451-3baa77f5e6d1": {
      "match": "brand_token",
      "title": "RYSTIGGO (ROZANOLIXIZUMAB) INJECTION, SOLUTION [UCB, INC.]",
      "spl_version": "10",
      "published_date": "2026-01-21"
    }
  },
  "productid": "50474-980_48d5f5c1-c45c-cb63-e063-6394a90a31c8",
  "productndc": "50474-980",
  "dosage_form": "INJECTION, SOLUTION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ROZANOLIXIZUMAB",
  "proprietary_name": "RYSTIGGO",
  "active_ingred_unit": "mg/mL",
  "application_number": "BLA761286",
  "marketing_category": "BLA",
  "nonproprietary_name": "ROZANOLIXIZUMAB",
  "start_marketing_date": "20230626",
  "active_numerator_strength": "140"
}

Related drugs

Other records sharing ATC code L04AG16.

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