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 Identifiers#

Field, Values table
FieldValues
UniiQ6U6J48BWY
Rxcui1726266, 1726268

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

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