FDA.reportPublic FDA data

Cerezyme

Product NDC
58468-4663
11-digit product format
584684663
Labeler code
58468
Product ID
58468-4663_6a32f852-ba91-4185-a618-0ba55a14442e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
IMIGLUCERASE
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Genzyme Corporation
Application
BLA020367
Marketing category
BLA
Marketing start
1994-05-23
Substance
IMIGLUCERASE
Active strength
40 U/mL
Pharmacologic classes
Glucosylceramidase [CS], Hydrolytic Lysosomal Glucocerebroside-specific Enzyme [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cerezyme
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IMIGLUCERASE40 U/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
Q6U6J48BWYInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1726266Internal RxNorm lookup
1726268Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
df60f030-866b-4374-a31f-8ae3f6b45c38Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
228602f2-000a-41a1-b62b-6b6d7406ed73Product name120220920

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58468-4663-12025-08-19C16284748780-13b156c62-3406-fb37-e063-e6dba90a4e07These highlights do not include all the information needed to use CEREZYME ® safely and effectively. See full prescribing information for CEREZYME. CEREZYME (imiglucerase) for injection, for intravenous use Initial U.S. Approval: 1994
58468-4663-12025-07-29C16284748780-13b156c62-3406-fb37-e063-e6dba90a4e07These highlights do not include all the information needed to use CEREZYME ® safely and effectively. See full prescribing information for CEREZYME. CEREZYME (imiglucerase) for injection, for intravenous use Initial U.S. Approval: 1994

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58468-4663-1Cerezyme10 mL in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,1026
58468-4663-1Cerezyme1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,126

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58468-4663-1EA - Each58468-466343197b45-0156-4563-a8a8-6f5d6dc5759012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IMIGLUCERASEACTIVE INGREDIENTQ6U6J48BWYCEREZYME (IMIGLUCERASE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENZYME CORPORATION]7
IMIGLUCERASEACTIVE MOIETYQ6U6J48BWYCEREZYME (IMIGLUCERASE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENZYME CORPORATION]7
DISODIUM HYDROGEN CITRATEINACTIVE INGREDIENT6FO62KCQ7ACEREZYME (IMIGLUCERASE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENZYME CORPORATION]7
MANNITOLINACTIVE INGREDIENT3OWL53L36ACEREZYME (IMIGLUCERASE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENZYME CORPORATION]7
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCEREZYME (IMIGLUCERASE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENZYME CORPORATION]7
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KCEREZYME (IMIGLUCERASE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENZYME CORPORATION]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58468-4663CEREZYME (IMIGLUCERASE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENZYME CORPORATION]24Current NDC, Legacy NDC, 2 package rows20250101_df60f030-866b-4374-a31f-8ae3f6b45c38.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
CerezymeIMIGLUCERASEGenzyme Corporationdf60f030-866b-4374-a31f-8ae3f6b45c382025-12-22Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA020367
ndc (product): 58468-4663

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
020367Cerezymeimiglucerase351(a)Disc2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1726268Cerezyme 400 UNT InjectionPSNdf60f030-866b-4374-a31f-8ae3f6b45c3826
1726266imiglucerase 400 UNT InjectionPSNdf60f030-866b-4374-a31f-8ae3f6b45c3826
1726268imiglucerase 400 UNT Injection [Cerezyme]SBDdf60f030-866b-4374-a31f-8ae3f6b45c3826
1726266imiglucerase 400 UNT InjectionSCDdf60f030-866b-4374-a31f-8ae3f6b45c3826
1726268Cerezyme 400 UNT InjectionSYdf60f030-866b-4374-a31f-8ae3f6b45c3826

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
58468-4663-1584684663011 VIAL, GLASS in 1 CARTON (58468-4663-1) / 10 mL in 1 VIAL, GLASS1994-05-230000-00-00NoNoCurrent