NDC 68135-020

NAGLAZYME

Galsulfase

NAGLAZYME is a Intravenous Solution in the Human Prescription Drug category. It is labeled and distributed by Biomarin Pharmaceutical Inc.. The primary component is Galsulfase.

• Product ID: 68135-020_428ca124-a4c4-467d-a7df-02457ffc1ad2
• NDC: 68135-020
• Product Type: Human Prescription Drug
• Proprietary Name: NAGLAZYME
• Generic Name: Galsulfase
• Dosage Form: Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2005-06-09
• Marketing Category: BLA / BLA
• Application Number: BLA125117
• Labeler Name: BioMarin Pharmaceutical Inc.
• Substance Name: GALSULFASE
• Active Ingredient Strength: 5 mg/5mL
• Pharm Classes: alpha-Glucosidases [CS],Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 68135-020-01

1 VIAL in 1 CARTON (68135-020-01) > 5 mL in 1 VIAL

• Marketing Start Date: 2005-06-09
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68135-020-01 [68135002001]

NAGLAZYME SOLUTION

• Marketing Category: BLA
• Application Number: BLA125117
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2005-06-09

Drug Details

Active Ingredients

Ingredient	Strength
GALSULFASE	5 mg/5mL

OpenFDA Data

• SPL SET ID: 59341250-deac-ed71-3823-a4f5d64dbd77
• Manufacturer:
  • BioMarin Pharmaceutical Inc.
• UNII:
  • 59UA429E5G
• RxNorm Concept Unique ID - RxCUI:
  • 578037
  • 584222

Pharmacological Class

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