Qfitlia

Orange BookUNIISPLATC B02BX

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

Identification

ManufacturerGenzyme Corporation

CountryUS (United States)

ATC codeB02BX

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5846803471
1 VIAL in 1 CARTON (58468-0347-1) / .2 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)

SV9W47ZLE1

FITUSIRAN

Orange Book

N219019

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "SV9W47ZLE1",
    "rxcui": null,
    "inchikey": null,
    "display_name": "FITUSIRAN",
    "substance_type": "nucleicAcid",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBCUTANEOUS",
  "spl_meta": {
    "6dd2f8ac-6f90-4cbf-b197-97d74964135c": {
      "match": "brand_token",
      "title": "QFITLIA (FITUSIRAN) INJECTION, SOLUTION [GENZYME CORPORATION]",
      "spl_version": "6",
      "published_date": "2025-09-18"
    }
  },
  "productid": "58468-0347_1c225007-61f2-4c48-a25e-f08b8d356a59",
  "productndc": "58468-0347",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "219019",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 20MG BASE/0.2ML (EQ 20MG BASE/0.2ML)",
        "product_no": "001",
        "approval_date": "Mar 28, 2025"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 50MG BASE/0.5ML (EQ 50MG BASE/0.5ML)",
        "product_no": "002",
        "approval_date": "Mar 28, 2025"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FITUSIRAN",
  "proprietary_name": "Qfitlia",
  "active_ingred_unit": "mg/.2mL",
  "application_number": "NDA219019",
  "marketing_category": "NDA",
  "nonproprietary_name": "fitusiran",
  "start_marketing_date": "20250328",
  "active_numerator_strength": "20"
}

Related drugs

Other records sharing ATC code B02BX.

Access this data programmatically

Query Qfitlia 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