NDC 50633-210

Voraxaze

Glucarpidase

Voraxaze is a Intravenous Injection, Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Btg International Inc.. The primary component is Glucarpidase.

• Product ID: 50633-210_070dbf0b-5886-4555-a280-4d3767ac9ebd
• NDC: 50633-210
• Product Type: Human Prescription Drug
• Proprietary Name: Voraxaze
• Generic Name: Glucarpidase
• Dosage Form: Injection, Powder, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2012-04-01
• Marketing Category: BLA / BLA
• Application Number: BLA125327
• Labeler Name: BTG International Inc.
• Substance Name: GLUCARPIDASE
• Active Ingredient Strength: 1000 [USP'U]/1
• Pharm Classes: Carboxypeptidase [EPC],Carboxypeptidases [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 50633-210-11

1 VIAL in 1 CARTON (50633-210-11) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL

• Marketing Start Date: 2012-04-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50633-210-11 [50633021011]

Voraxaze INJECTION, POWDER, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA125327
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2012-04-01

Drug Details

Active Ingredients

Ingredient	Strength
GLUCARPIDASE	1000 [USP'U]/1

OpenFDA Data

• SPL SET ID: acaef5a6-b740-40e3-8ffe-74a75c74745c
• Manufacturer:
  • BTG International Inc.
• UNII:
  • 2GFP9BJD79
• RxNorm Concept Unique ID - RxCUI:
  • 1242131
  • 1242136

Pharmacological Class

• Carboxypeptidase [EPC]
• Carboxypeptidases [CS]