NDC 69794-001

MEPSEVII

Vestronidase Alfa

MEPSEVII is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Ultragenyx Pharmaceutical Inc.. The primary component is Vestronidase Alfa.

• Product ID: 69794-001_775380cc-c773-4413-89e8-46cbf74f2ec3
• NDC: 69794-001
• Product Type: Human Prescription Drug
• Proprietary Name: MEPSEVII
• Generic Name: Vestronidase Alfa
• Dosage Form: Injection
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2017-11-15
• Marketing Category: BLA / BLA
• Application Number: BLA761047
• Labeler Name: Ultragenyx Pharmaceutical Inc.
• Substance Name: VESTRONIDASE ALFA
• Active Ingredient Strength: 2 mg/mL
• Pharm Classes: Lysosomal beta Glucuronidase [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 69794-001-01

1 VIAL, SINGLE-USE in 1 CARTON (69794-001-01) > 5 mL in 1 VIAL, SINGLE-USE

• Marketing Start Date: 2017-11-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69794-001-01 [69794000101]

MEPSEVII INJECTION

• Marketing Category: BLA
• Application Number: BLA761047
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-11-15

Drug Details

Active Ingredients

Ingredient	Strength
VESTRONIDASE ALFA	2 mg/mL

OpenFDA Data

• SPL SET ID: 925d4e21-fd98-474d-a34d-a0b3558ed750
• Manufacturer:
  • Ultragenyx Pharmaceutical Inc.
• UNII:
  • 7XZ4062R17
• RxNorm Concept Unique ID - RxCUI:
  • 1989828
  • 1989823

Pharmacological Class

• Lysosomal beta Glucuronidase [EPC]