NDC 58468-0070

ALDURAZYME

Laronidase

ALDURAZYME is a Intravenous Injection, Solution, Concentrate in the Human Prescription Drug category. It is labeled and distributed by Genzyme Corporation. The primary component is Laronidase.

• Product ID: 58468-0070_00fbeee3-0dad-4b6f-8f7b-cf596fe2d37c
• NDC: 58468-0070
• Product Type: Human Prescription Drug
• Proprietary Name: ALDURAZYME
• Generic Name: Laronidase
• Dosage Form: Injection, Solution, Concentrate
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2003-04-30
• Marketing Category: BLA / BLA
• Application Number: BLA125058
• Labeler Name: Genzyme Corporation
• Substance Name: LARONIDASE
• Active Ingredient Strength: 3 mg/5mL
• Pharm Classes: alpha-Glucosidases [CS],Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 58468-0070-1

5 mL in 1 VIAL, GLASS (58468-0070-1)

• Marketing Start Date: 2003-04-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 58468-0070-1 [58468007001]

ALDURAZYME INJECTION, SOLUTION, CONCENTRATE

• Marketing Category: BLA
• Application Number: BLA125058
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2003-04-30

Drug Details

Active Ingredients

Ingredient	Strength
LARONIDASE	2.9 mg/5mL

OpenFDA Data

• SPL SET ID: a80ac249-cae4-41f3-88bb-344088b20e60
• Manufacturer:
  • Genzyme Corporation
• UNII:
  • WP58SVM6R4
• RxNorm Concept Unique ID - RxCUI:
  • 403822
  • 404492
• UPC Code:
  • 0358468198310

Pharmacological Class

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