NDC 58468-0160

Lumizyme

Alglucosidase Alfa

Lumizyme is a Intravenous Injection, Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Genzyme Corporation. The primary component is Alglucosidase Alfa.

• Product ID: 58468-0160_00f8e613-9d69-41c2-a6e0-a036a9a82516
• NDC: 58468-0160
• Product Type: Human Prescription Drug
• Proprietary Name: Lumizyme
• Generic Name: Alglucosidase Alfa
• Dosage Form: Injection, Powder, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2010-05-24
• Marketing Category: BLA / BLA
• Application Number: BLA125291
• Labeler Name: Genzyme Corporation
• Substance Name: ALGLUCOSIDASE ALFA
• Active Ingredient Strength: 5 mg/mL
• Pharm Classes: alpha-Glucosidases [CS],Hydrolytic Lysosomal Glycogen-specific Enzyme [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 58468-0160-1

1 VIAL, SINGLE-USE in 1 CARTON (58468-0160-1) > 10.5 mL in 1 VIAL, SINGLE-USE

• Marketing Start Date: 2010-05-24
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 58468-0160-2 [58468016002]

Lumizyme INJECTION, POWDER, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA125291
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2010-05-24

NDC 58468-0160-1 [58468016001]

Lumizyme INJECTION, POWDER, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA125291
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2010-05-24

Drug Details

Active Ingredients

Ingredient	Strength
ALGLUCOSIDASE ALFA	5 mg/mL

OpenFDA Data

• SPL SET ID: d6bfbc45-2d34-439e-8aad-59ee2d53d4df
• Manufacturer:
  • Genzyme Corporation
• UNII:
  • DTI67O9503
• RxNorm Concept Unique ID - RxCUI:
  • 629568
  • 993072

Pharmacological Class

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