NDC 68135-100

VIMIZIM

Elosulfase Alfa

VIMIZIM is a Intravenous Injection, Solution, Concentrate in the Human Prescription Drug category. It is labeled and distributed by Biomarin Pharmaceutical Inc.. The primary component is Elosulfase Alfa.

• Product ID: 68135-100_167e8674-e1eb-4d1d-a42e-d0454e8c231c
• NDC: 68135-100
• Product Type: Human Prescription Drug
• Proprietary Name: VIMIZIM
• Generic Name: Elosulfase Alfa
• Dosage Form: Injection, Solution, Concentrate
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2014-02-14
• Marketing Category: BLA / BLA
• Application Number: BLA125460
• Labeler Name: BioMarin Pharmaceutical Inc.
• Substance Name: ELOSULFASE ALFA
• Active Ingredient Strength: 5 mg/5mL
• Pharm Classes: alpha-Glucosidases [CS],Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 68135-100-01

1 VIAL in 1 CARTON (68135-100-01) > 5 mL in 1 VIAL

• Marketing Start Date: 2014-02-14
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68135-100-01 [68135010001]

VIMIZIM INJECTION, SOLUTION, CONCENTRATE

• Marketing Category: BLA
• Application Number: BLA125460
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2014-02-14

Drug Details

Active Ingredients

Ingredient	Strength
ELOSULFASE ALFA	5 mg/5mL

OpenFDA Data

• SPL SET ID: 0caa2565-12b2-0ad0-1f9a-273e81c3d4cc
• Manufacturer:
  • BioMarin Pharmaceutical Inc.
• UNII:
  • ODJ69JZG85
• RxNorm Concept Unique ID - RxCUI:
  • 1490047
  • 1490052

Pharmacological Class

• alpha-Glucosidases [CS]
• Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme [EPC]