NDC 54092-701

VPRIV

Velaglucerase Alfa

VPRIV is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Shire Us Manufacturing Inc.. The primary component is Velaglucerase Alfa.

• Product ID: 54092-701_2c0fd37c-bd95-4145-91d3-4523da16e149
• NDC: 54092-701
• Product Type: Human Prescription Drug
• Proprietary Name: VPRIV
• Generic Name: Velaglucerase Alfa
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2010-02-26
• Marketing Category: BLA / NDA
• Application Number: BLA022575
• Labeler Name: Shire US Manufacturing Inc.
• Substance Name: VELAGLUCERASE ALFA
• Active Ingredient Strength: 3 mg/mL
• Pharm Classes: Hydrolytic Lysosomal Glucocerebroside-specific Enzyme [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 54092-701-04

1 VIAL, GLASS in 1 BOX (54092-701-04) > 4 mL in 1 VIAL, GLASS

• Marketing Start Date: 2010-02-26
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 54092-701-02 [54092070102]

VPRIV INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA022575
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2010-02-26
• Marketing End Date: 2013-02-20

NDC 54092-701-04 [54092070104]

VPRIV INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA022575
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2010-02-26

Drug Details

Active Ingredients

Ingredient	Strength
VELAGLUCERASE ALFA	2.5 mg/mL

OpenFDA Data

• SPL SET ID: ca02f7a4-ae4f-43c1-a06a-259fe4fcf9cf
• Manufacturer:
  • Shire US Manufacturing Inc.
• UNII:
  • 23HYE36B0I
• RxNorm Concept Unique ID - RxCUI:
  • 901808
  • 901812

Pharmacological Class

• Hydrolytic Lysosomal Glucocerebroside-specific Enzyme [EPC]