Brineura

SPL

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

Identification

ManufacturerBioMarin Pharmaceutical Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6813581102
1 KIT in 1 CARTON (68135-811-02) * 5 mL in 1 VIAL, GLASS (68135-500-00) * 5 mL in 1 VIAL, GLASS (68135-495-04)

Annotations

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "485ab3c5-0359-4878-872f-2fe1e7df4047": {
      "match": "brand_token",
      "title": "BRINEURA (CERLIPONASE ALFA) KIT [BIOMARIN PHARMACEUTICAL INC.]",
      "spl_version": "30",
      "published_date": "2024-08-08"
    }
  },
  "productid": "68135-811_1ebeb049-90ec-42ff-9361-b6fa38d79515",
  "productndc": "68135-811",
  "dosage_form": "KIT",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Brineura",
  "active_ingred_unit": null,
  "application_number": "BLA761052",
  "marketing_category": "BLA",
  "nonproprietary_name": "cerliponase alfa",
  "start_marketing_date": "20170427",
  "active_numerator_strength": null
}

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