NDC 58468-0040

Fabrazyme

Agalsidase Beta

Fabrazyme is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Genzyme Corporation. The primary component is Agalsidase Beta.

• Product ID: 58468-0040_0339a000-641e-4081-8901-4d000be85390
• NDC: 58468-0040
• Product Type: Human Prescription Drug
• Proprietary Name: Fabrazyme
• Generic Name: Agalsidase Beta
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2008-12-17
• Marketing Category: BLA / BLA
• Application Number: BLA103979
• Labeler Name: Genzyme Corporation
• Substance Name: AGALSIDASE BETA
• Active Ingredient Strength: 5 mg/mL
• Pharm Classes: alpha-Glucosidases [CS],Hydrolytic Lysosomal Neutral Glycosphingolipid-specific Enzyme [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 58468-0040-1

1 VIAL, GLASS in 1 CARTON (58468-0040-1) > 7 mL in 1 VIAL, GLASS

• Marketing Start Date: 2008-12-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 58468-0040-1 [58468004001]

Fabrazyme INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA103979
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2008-12-17

Drug Details

Active Ingredients

Ingredient	Strength
AGALSIDASE BETA	5 mg/mL

OpenFDA Data

• SPL SET ID: 988513ab-b06f-4dd0-93f7-d2d4531dcce4
• Manufacturer:
  • Genzyme Corporation
• UNII:
  • RZD65TSM9U
• RxNorm Concept Unique ID - RxCUI:
  • 1804755
  • 1804762
  • 1804758
  • 1804760

Pharmacological Class

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

NDC Crossover Matching brand name "Fabrazyme" or generic name "Agalsidase Beta"

NDC	Brand Name	Generic Name
58468-0040	Fabrazyme	AGALSIDASE BETA
58468-0041	Fabrazyme	AGALSIDASE BETA