vpriv

Generic: velaglucerase alfa

Labeler: takeda pharmaceuticals america, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name vpriv
Generic Name velaglucerase alfa
Labeler takeda pharmaceuticals america, inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

velaglucerase alfa 2.5 mg/mL

Manufacturer
Takeda Pharmaceuticals America, Inc.

Identifiers & Regulatory

Product NDC 54092-701
Product ID 54092-701_27f96d8e-a6e0-4743-a76c-00f979bfb5f7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA022575
Listing Expiration 2026-12-31
Marketing Start 2010-02-26

Pharmacologic Class

Established (EPC)
hydrolytic lysosomal glucocerebroside-specific enzyme [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 54092701
Hyphenated Format 54092-701

Supplemental Identifiers

RxCUI
901808 901812
UNII
23HYE36B0I
NUI
N0000175820

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name vpriv (source: ndc)
Generic Name velaglucerase alfa (source: ndc)
Application Number BLA022575 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/mL
source: ndc
Packaging
  • 1 VIAL, GLASS in 1 BOX (54092-701-04) / 4 mL in 1 VIAL, GLASS
source: ndc

Packages (1)

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

Ingredients (1)

velaglucerase alfa (2.5 mg/mL)

Linked Drug Pages (1)

VPRIV ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "27f96d8e-a6e0-4743-a76c-00f979bfb5f7", "openfda": {"nui": ["N0000175820"], "unii": ["23HYE36B0I"], "rxcui": ["901808", "901812"], "spl_set_id": ["ca02f7a4-ae4f-43c1-a06a-259fe4fcf9cf"], "pharm_class_epc": ["Hydrolytic Lysosomal Glucocerebroside-specific Enzyme [EPC]"], "manufacturer_name": ["Takeda Pharmaceuticals America, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 BOX (54092-701-04)  / 4 mL in 1 VIAL, GLASS", "package_ndc": "54092-701-04", "marketing_start_date": "20100226"}], "brand_name": "VPRIV", "product_id": "54092-701_27f96d8e-a6e0-4743-a76c-00f979bfb5f7", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Hydrolytic Lysosomal Glucocerebroside-specific Enzyme [EPC]"], "product_ndc": "54092-701", "generic_name": "velaglucerase alfa", "labeler_name": "Takeda Pharmaceuticals America, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "VPRIV", "active_ingredients": [{"name": "VELAGLUCERASE ALFA", "strength": "2.5 mg/mL"}], "application_number": "BLA022575", "marketing_category": "BLA", "marketing_start_date": "20100226", "listing_expiration_date": "20261231"}