FDA.reportPublic FDA data

Fabrazyme

Product NDC
58468-0040
11-digit product format
584680040
Labeler code
58468
Product ID
58468-0040_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 Identifiers#

Field, Values table
FieldValues
UniiRZD65TSM9U
Rxcui1804755, 1804758, 1804760, 1804762

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58468-0040-12025-08-22C16284748780-10191ceaa-70da-198a-e063-dbdaa90aec3eThese 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
58468-0040-12025-07-29C16284748780-10191ceaa-70da-198a-e063-dbdaa90aec3eThese 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
58468-0040-12023-08-07C16284748780-10191ceaa-70da-198a-e063-dbdaa90aec3eThese 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
58468-0040-12023-07-28C16284748780-10191ceaa-70da-198a-e063-dbdaa90aec3eThese 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
58468-0040-1Fabrazyme1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,135
58468-0040-1Fabrazyme7 mL in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,735

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58468-0040-1EA - Each58468-0040835fb52d-bc09-4d09-8f57-b0eb38bf598f12012-07-24

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
58468-0040FABRAZYME (AGALSIDASE BETA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENZYME CORPORATION]34Current NDC, Legacy NDC, 2 package rows20240718_988513ab-b06f-4dd0-93f7-d2d4531dcce4.zip

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
58468-0040-1584680040011 VIAL, GLASS in 1 CARTON (58468-0040-1) / 7 mL in 1 VIAL, GLASS2008-12-170000-00-00NoNoCurrent