ZILBRYSQ

Orange BookUNIISPLATC L04AJ06

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

Identification

ManufacturerUCB, Inc.

CountryUS (United States)

ATC codeL04AJ06

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5047499180
4 CARTON in 1 BOX (50474-991-80) / 7 SYRINGE, GLASS in 1 CARTON / .574 mL in 1 SYRINGE, GLASS

Annotations

UNII (FDA Substance ID)

YG391PK0CC

ZILUCOPLAN

Orange Book

N216834

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "YG391PK0CC",
    "rxcui": null,
    "inchikey": "JDXCOXKBIGBZSK-PSNKNOTQSA-N",
    "display_name": "ZILUCOPLAN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBCUTANEOUS",
  "spl_meta": {
    "9f1d53d6-e495-4a3a-8bb9-680a15d25034": {
      "match": "brand_token",
      "title": "ZILBRYSQ (ZILUCOPLAN) INJECTION, SOLUTION [UCB, INC.]",
      "spl_version": "13",
      "published_date": "2026-02-05"
    }
  },
  "productid": "50474-991_49eeeabf-4c62-63cb-e063-6394a90a8248",
  "productndc": "50474-991",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "216834",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 16.6MG BASE/0.416ML (EQ 16.6MG BASE/0.416ML)",
        "product_no": "001",
        "approval_date": "Oct 17, 2023"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 23MG BASE/0.574ML (EQ 23MG BASE/0.574ML)",
        "product_no": "002",
        "approval_date": "Oct 17, 2023"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 32.4MG BASE/0.81ML (EQ 32.4 BASE/0.81ML)",
        "product_no": "003",
        "approval_date": "Oct 17, 2023"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ZILUCOPLAN",
  "proprietary_name": "ZILBRYSQ",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA216834",
  "marketing_category": "NDA",
  "nonproprietary_name": "zilucoplan",
  "start_marketing_date": "20240103",
  "active_numerator_strength": "40"
}

Related drugs

Other records sharing ATC code L04AJ06.

Access this data programmatically

Query ZILBRYSQ and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs