NDC 68135-811

Brineura

Cerliponase Alfa

Brineura is a Intraventricular Kit in the Human Prescription Drug category. It is labeled and distributed by Biomarin Pharmaceutical Inc.. The primary component is .

• Product ID: 68135-811_0b899098-da74-4819-86bb-42f0941aff6c
• NDC: 68135-811
• Product Type: Human Prescription Drug
• Proprietary Name: Brineura
• Generic Name: Cerliponase Alfa
• Dosage Form: Kit
• Route of Administration: INTRAVENTRICULAR
• Marketing Start Date: 2017-04-27
• Marketing Category: BLA / BLA
• Application Number: BLA761052
• Labeler Name: BioMarin Pharmaceutical Inc.
• Active Ingredient Strength: 0
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 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)

• Marketing Start Date: 2017-04-27
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68135-811-02 [68135081102]

Brineura KIT

• Marketing Category: BLA
• Application Number: BLA761052
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-04-27

Drug Details

OpenFDA Data

• SPL SET ID: 485ab3c5-0359-4878-872f-2fe1e7df4047
• Manufacturer:
  • BioMarin Pharmaceutical Inc.
• RxNorm Concept Unique ID - RxCUI:
  • 1922453
  • 1922458