brineura

Generic: cerliponase alfa

Labeler: biomarin pharmaceutical inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name brineura
Generic Name cerliponase alfa
Labeler biomarin pharmaceutical inc.
Dosage Form KIT
Manufacturer
BioMarin Pharmaceutical Inc.

Identifiers & Regulatory

Product NDC 68135-811
Product ID 68135-811_1ebeb049-90ec-42ff-9361-b6fa38d79515
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761052
Listing Expiration 2026-12-31
Marketing Start 2017-04-27

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68135811
Hyphenated Format 68135-811

Supplemental Identifiers

RxCUI
1922453 1922458

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name brineura (source: ndc)
Generic Name cerliponase alfa (source: ndc)
Application Number BLA761052 (source: ndc)

Resolved Composition

Strengths
  • 150 mg/5 ml
  • 30 mg/ml
  • 5 ml
  • 150 mg
  • 21 g
  • 22 g
source: label
Packaging
  • 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)
source: ndc

Packages (1)

68135-811-02 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)

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Brineura ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "1ebeb049-90ec-42ff-9361-b6fa38d79515", "openfda": {"rxcui": ["1922453", "1922458"], "spl_set_id": ["485ab3c5-0359-4878-872f-2fe1e7df4047"], "manufacturer_name": ["BioMarin Pharmaceutical Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "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)", "package_ndc": "68135-811-02", "marketing_start_date": "20170427"}], "brand_name": "Brineura", "product_id": "68135-811_1ebeb049-90ec-42ff-9361-b6fa38d79515", "dosage_form": "KIT", "product_ndc": "68135-811", "generic_name": "cerliponase alfa", "labeler_name": "BioMarin Pharmaceutical Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Brineura", "application_number": "BLA761052", "marketing_category": "BLA", "marketing_start_date": "20170427", "listing_expiration_date": "20261231"}