FDA.reportPublic FDA data

Fabrazyme

Product NDC
58468-0041
11-digit product format
584680041
Labeler code
58468
Product ID
58468-0041_9b786f81-f4d8-4bc6-8f5f-68adbbfb60d1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AGALSIDASE BETA
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Genzyme Corporation
Application
BLA103979
Marketing category
BLA
Marketing start
2008-12-17
Substance
AGALSIDASE BETA
Active strength
5 mg/mL
Pharmacologic classes
Hydrolytic Lysosomal Neutral Glycosphingolipid-specific Enzyme [EPC], alpha-Glucosidases [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AGALSIDASE BETA5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
RZD65TSM9UInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1804755Internal RxNorm lookup
1804758Internal RxNorm lookup
1804760Internal RxNorm lookup
1804762Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
988513ab-b06f-4dd0-93f7-d2d4531dcce4Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
8bf4f9a7-3261-4e1d-b8d5-28c39de0898bProduct name120210903
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2025-08-22These highlights do not include all the information needed to use FABRAZYME ® safely and effectively. See full prescribing information for FABRAZYME ® . FABRAZYME ® (agalsidase beta) for injection, for intravenous use Initial U.S. Approval: 2003
2025-07-29These highlights do not include all the information needed to use FABRAZYME ® safely and effectively. See full prescribing information for FABRAZYME ® . FABRAZYME ® (agalsidase beta) for injection, for intravenous use Initial U.S. Approval: 2003
2023-08-07These highlights do not include all the information needed to use FABRAZYME ® safely and effectively. See full prescribing information for FABRAZYME ® . FABRAZYME ® (agalsidase beta) for injection, for intravenous use Initial U.S. Approval: 2003
2023-07-28These highlights do not include all the information needed to use FABRAZYME ® safely and effectively. See full prescribing information for FABRAZYME ® . FABRAZYME ® (agalsidase beta) for injection, for intravenous use Initial U.S. Approval: 2003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58468-0041-1Fabrazyme1 mL in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,135
58468-0041-1Fabrazyme1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,135

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58468-0041-1EA - Each58468-0041064c6fe9-ec85-4057-baa6-b19ea2564ba112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AGALSIDASE BETAACTIVE INGREDIENTRZD65TSM9UFABRAZYME (AGALSIDASE BETA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENZYME CORPORATION]17
AGALSIDASE BETAACTIVE MOIETYRZD65TSM9UFABRAZYME (AGALSIDASE BETA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENZYME CORPORATION]17
MANNITOLINACTIVE INGREDIENT3OWL53L36AFABRAZYME (AGALSIDASE BETA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENZYME CORPORATION]17
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEINACTIVE INGREDIENT70WT22SF4BFABRAZYME (AGALSIDASE BETA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENZYME CORPORATION]17
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEINACTIVE INGREDIENT593YOG76RNFABRAZYME (AGALSIDASE BETA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENZYME CORPORATION]17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58468-0041FABRAZYME (AGALSIDASE BETA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENZYME CORPORATION]34Current NDC, Legacy NDC, 2 package rows20240718_988513ab-b06f-4dd0-93f7-d2d4531dcce4.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
FabrazymeAGALSIDASE BETAGenzyme Corporation988513ab-b06f-4dd0-93f7-d2d4531dcce42025-08-22Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA103979
ndc (product): 58468-0041

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103979Fabrazymeagalsidase beta351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1804755agalsidase beta 35 MG InjectionPSN988513ab-b06f-4dd0-93f7-d2d4531dcce435
1804760agalsidase beta 5 MG InjectionPSN988513ab-b06f-4dd0-93f7-d2d4531dcce435
1804758Fabrazyme 35 MG InjectionPSN988513ab-b06f-4dd0-93f7-d2d4531dcce435
1804762Fabrazyme 5 MG InjectionPSN988513ab-b06f-4dd0-93f7-d2d4531dcce435
1804758agalsidase beta 35 MG Injection [Fabrazyme]SBD988513ab-b06f-4dd0-93f7-d2d4531dcce435
1804762agalsidase beta 5 MG Injection [Fabrazyme]SBD988513ab-b06f-4dd0-93f7-d2d4531dcce435
1804755agalsidase beta 35 MG InjectionSCD988513ab-b06f-4dd0-93f7-d2d4531dcce435
1804760agalsidase beta 5 MG InjectionSCD988513ab-b06f-4dd0-93f7-d2d4531dcce435
1804758Fabrazyme 35 MG InjectionSY988513ab-b06f-4dd0-93f7-d2d4531dcce435
1804762Fabrazyme 5 MG InjectionSY988513ab-b06f-4dd0-93f7-d2d4531dcce435

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
58468-0041-1584680041011 VIAL, GLASS in 1 CARTON (58468-0041-1) / 1 mL in 1 VIAL, GLASS2008-12-170000-00-00NoNoCurrent