FDA.reportPublic FDA data

XENPOZYME

Product NDC
58468-0051
Requested package NDC
58468-0051-1
11-digit product format
584680051
Labeler code
58468
Product ID
58468-0051_ce8d4153-ce95-43c4-9672-e1e951ebcdaa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
olipudase alfa-rpcp
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Genzyme Corporation
Application
BLA761261
Marketing category
BLA
Marketing start
2022-08-29
Substance
OLIPUDASE ALFA
Active strength
4 mg/1.1mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
XENPOZYME
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OLIPUDASE ALFA4 mg/1.1mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6D5766Q4OPInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2610411Internal RxNorm lookup
2610416Internal RxNorm lookup
2634357Internal RxNorm lookup
2634359Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
01a910ee-a33e-4be3-ac41-322d64c34311Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58468-0051-1XENPOZYME1.1 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,1.110
58468-0051-1XENPOZYME1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58468-0051-1EA - Each58468-00518a65b3ec-0360-425b-9102-058e2d8e760212023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58468-0051XENPOZYME (OLIPUDASE ALFA-RPCP) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENZYME CORPORATION]9Current NDC, 2 package rows20250306_01a910ee-a33e-4be3-ac41-322d64c34311.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
XENPOZYMEOLIPUDASE ALFA-RPCPGenzyme Corporation01a910ee-a33e-4be3-ac41-322d64c343112025-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761261
ndc (package): 58468-0051-1
ndc (product): 58468-0051
ndc11 (package): 58468005101

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761261Xenpozymeolipudase alfa-rpcp351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2610411olipudase alfa-rpcp 20 MG InjectionPSN01a910ee-a33e-4be3-ac41-322d64c3431110
2634357olipudase alfa-rpcp 4 MG InjectionPSN01a910ee-a33e-4be3-ac41-322d64c3431110
2610416Xenpozyme 20 MG InjectionPSN01a910ee-a33e-4be3-ac41-322d64c3431110
2634359Xenpozyme 4 MG InjectionPSN01a910ee-a33e-4be3-ac41-322d64c3431110
2610416olipudase alfa-rpcp 20 MG Injection [Xenpozyme]SBD01a910ee-a33e-4be3-ac41-322d64c3431110
2634359olipudase alfa-rpcp 4 MG Injection [Xenpozyme]SBD01a910ee-a33e-4be3-ac41-322d64c3431110
2610411olipudase alfa-rpcp 20 MG InjectionSCD01a910ee-a33e-4be3-ac41-322d64c3431110
2634357olipudase alfa-rpcp 4 MG InjectionSCD01a910ee-a33e-4be3-ac41-322d64c3431110
2610416Xenpozyme 20 MG InjectionSY01a910ee-a33e-4be3-ac41-322d64c3431110
2634359Xenpozyme 4 MG InjectionSY01a910ee-a33e-4be3-ac41-322d64c3431110

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58468-0051-1584680051011 VIAL in 1 CARTON (58468-0051-1) / 1.1 mL in 1 VIAL1 vial2022-08-29NoNoCurrent