FDA.reportPublic FDA data

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
IngredientStrength
VELAGLUCERASE ALFA2.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii23HYE36B0I
Rxcui901808, 901812

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54092-701-04VPRIV4 mL in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,427
54092-701-04VPRIV1 in 1 BOXINJECTION, POWDER, LYOPHILIZED,127

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54092-701-04EA - Each54092-7018f2cd7b6-702a-464e-90e0-e70b5478d6d312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
velaglucerase alfaACTIVE INGREDIENT23HYE36B0IVPRIV (VELAGLUCERASE ALFA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SHIRE US MANUFACTURING INC.]12
velaglucerase alfaACTIVE MOIETY23HYE36B0IVPRIV (VELAGLUCERASE ALFA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SHIRE US MANUFACTURING INC.]12
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPVPRIV (VELAGLUCERASE ALFA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SHIRE US MANUFACTURING INC.]12
polysorbate 20INACTIVE INGREDIENT7T1F30V5YHVPRIV (VELAGLUCERASE ALFA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SHIRE US MANUFACTURING INC.]12
sucroseINACTIVE INGREDIENTC151H8M554VPRIV (VELAGLUCERASE ALFA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SHIRE US MANUFACTURING INC.]12
trisodium citrate dihydrateINACTIVE INGREDIENTB22547B95KVPRIV (VELAGLUCERASE ALFA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SHIRE US MANUFACTURING INC.]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54092-701VPRIV (VELAGLUCERASE ALFA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [TAKEDA PHARMACEUTICALS AMERICA, INC.]27Current NDC, Legacy NDC, 2 package rows20241211_ca02f7a4-ae4f-43c1-a06a-259fe4fcf9cf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
901808velaglucerase alfa 400 UNT InjectionPSNca02f7a4-ae4f-43c1-a06a-259fe4fcf9cf27
901812VPRIV 400 UNT InjectionPSNca02f7a4-ae4f-43c1-a06a-259fe4fcf9cf27
901812velaglucerase alfa 400 UNT Injection [Vpriv]SBDca02f7a4-ae4f-43c1-a06a-259fe4fcf9cf27
901808velaglucerase alfa 400 UNT InjectionSCDca02f7a4-ae4f-43c1-a06a-259fe4fcf9cf27
901812Vpriv 400 UNT InjectionSYca02f7a4-ae4f-43c1-a06a-259fe4fcf9cf27

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
54092-701-04540920701041 VIAL, GLASS in 1 BOX (54092-701-04) / 4 mL in 1 VIAL, GLASS2010-02-260000-00-00NoNoCurrent