Home NDC 54092-701 VPRIV
Product NDC 54092-701
11-digit product format 540920701
Labeler code 54092
Product ID 54092-701_27f96d8e-a6e0-4743-a76c-00f979bfb5f7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name velaglucerase alfa
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Takeda Pharmaceuticals America, Inc.
Application BLA022575
Marketing category BLA
Marketing start 2010-02-26
Substance VELAGLUCERASE ALFA
Active strength 2.5 mg/mL
Pharmacologic classes Hydrolytic Lysosomal Glucocerebroside-specific Enzyme [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base VPRIV
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VELAGLUCERASE ALFA 2.5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 23HYE36B0I Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 901808 Internal RxNorm lookup 901812 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 54092-701-04 VPRIV 4 mL in 1 VIAL, GLASS INJECTION, POWDER, LYOPHILIZED, 4 27 54092-701-04 VPRIV 1 in 1 BOX INJECTION, POWDER, LYOPHILIZED, 1 27
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded velaglucerase alfa ACTIVE INGREDIENT 23HYE36B0I VPRIV (VELAGLUCERASE ALFA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SHIRE US MANUFACTURING INC.] 12 velaglucerase alfa ACTIVE MOIETY 23HYE36B0I VPRIV (VELAGLUCERASE ALFA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SHIRE US MANUFACTURING INC.] 12 citric acid monohydrate INACTIVE INGREDIENT 2968PHW8QP VPRIV (VELAGLUCERASE ALFA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SHIRE US MANUFACTURING INC.] 12 polysorbate 20 INACTIVE INGREDIENT 7T1F30V5YH VPRIV (VELAGLUCERASE ALFA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SHIRE US MANUFACTURING INC.] 12 sucrose INACTIVE INGREDIENT C151H8M554 VPRIV (VELAGLUCERASE ALFA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SHIRE US MANUFACTURING INC.] 12 trisodium citrate dihydrate INACTIVE INGREDIENT B22547B95K VPRIV (VELAGLUCERASE ALFA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SHIRE US MANUFACTURING INC.] 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54092-701 VPRIV (VELAGLUCERASE ALFA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [TAKEDA PHARMACEUTICALS AMERICA, INC.] 27 Current NDC, Legacy NDC, 2 package rows 20241211_ca02f7a4-ae4f-43c1-a06a-259fe4fcf9cf.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join VPRIV VELAGLUCERASE ALFA Takeda Pharmaceuticals America, Inc. ca02f7a4-ae4f-43c1-a06a-259fe4fcf9cf 2024-11-26 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA022575 ndc (product): 54092-701
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 022575 VPRIV velaglucerase alfa 351(a) Rx 2026-07-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 54092-701-04 54092070104 1 VIAL, GLASS in 1 BOX (54092-701-04) / 4 mL in 1 VIAL, GLASS 2010-02-26 0000-00-00 No No Current