FDA.reportPublic FDA data

NDC 58468-4663-01 - Cerezyme

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
58468-4663
Requested NDC
58468-4663-01
Package NDCs from labels
58468-4663-1, 58468-4663-01
Manufacturer
Genzyme Corporation | Genzyme Ireland Limited | Charles River Laboratories, Inc. | Eurofins Biopharma Product Testing Ireland Limited | Sanofi S.r.l.
Effective date
2026-08-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
CerezymeGenzyme Corporation | Genzyme Ireland Limited | Charles River Laboratories, Inc. | Eurofins Biopharma Product Testing Ireland Limited | Sanofi S.r.l.2026-08-27HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2025-08-19These 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
2025-08-19These 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
2025-07-29These 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
2025-07-29These 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 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 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

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 4 · 63 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CerezymeIMIGLUCERASEGenzyme Corporationdf60f030-866b-4374-a31f-8ae3f6b45c382026-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA020367
ndc (package): 58468-4663-1
ndc (product): 58468-4663
ndc11 (package): 58468466301
rxcui: 1726268
rxcui: 1726266
spl id: fc9b5df4-94e5-43b1-a827-dff85f7cf510
spl set id: df60f030-866b-4374-a31f-8ae3f6b45c38
unii: Q6U6J48BWY
Rohto Max StrengthNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companye4b49550-1ca3-4bd7-854d-409b53fa5e262026-08-20WarningsExact identifier
unii: 6OZP39ZG8H
CVS Health Nausea ReliefSODIUM CITRATE DIHYDRATECVS PHARMACY,INC.a5f9de6f-70d8-4bb0-8a5b-3dd120df29902026-08-14WarningsExact identifier
unii: B22547B95K
Droptics Dry Eye ReliefCARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80Droptics LLC29d7614b-f4b7-48e2-97c5-d1bff27731d22026-07-22WarningsExact identifier
unii: 6OZP39ZG8H
Rohto Cool ReliefNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companydc8f1ff3-87ae-47ca-815f-5a0e34f8cf302026-06-19WarningsExact identifier
unii: 6OZP39ZG8H
ACD ACITRIC ACID MONOHYDRATE, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATETerumo BCT, Ltd.395aec48-198a-4aed-8e38-7accfb3232f92026-06-15Warnings, Adverse reactionsExact identifier
unii: B22547B95K
ACD ACITRIC ACID MONOHYDRATE, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATETerumo BCT, Ltd8e255bc7-a120-460a-a32d-43931f8115de2026-05-21Warnings, Adverse reactionsExact identifier
unii: B22547B95K
MannitolMANNITOLHospira, Inc.8ad3145e-00e7-4412-b9a5-06f00f264f302026-04-21Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Anticoagulant Sodium CitrateTRISODIUM CITRATE DIHYDRATELABORATORIOS GRIFOLS SAdb8334be-5b8b-4811-811a-efbe32b6d1472026-04-14WarningsExact identifier
unii: B22547B95K
Refresh Optive Mega-3 PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.326cb5d6-c784-404f-9a13-6d69262dda6e2026-03-01WarningsExact identifier
unii: 6OZP39ZG8H
Additive Formula 3DEXTROSE MONOHYDRATE, TRISODIUM CITRATE DIHYDRATE, SODIUM CHLORIDE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, CITRIC ACID MONOHYDRATE, AND ADENINETerumo BCT, Ltd9a5247a1-cc05-442d-b2d0-950f887f03c22026-01-30Warnings, Adverse reactionsExact identifier
unii: B22547B95K
WALGREENS UPSET STOMACH and NAUSEA RELIEFSODIUM CITRATE DIHYDRATEWALGREENS CO.2de7ff66-af75-4d9d-b493-29b37dadc5d82026-01-15WarningsExact identifier
unii: B22547B95K
QR PAINANALGESICMARYHELENE ENTERPRISES INC8f8f53e3-fe31-e7b5-e053-2995a90a710d2025-11-14WarningsExact identifier
unii: 3OWL53L36A
QR PAINANALGESICMARYHELENE ENTERPRISES INC9984a510-30be-4013-e053-2995a90a841e2025-11-14WarningsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLProPharma Distribution430669d7-9ad1-9a04-e063-6394a90ababb2025-11-07Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Sorbitol-MannitolSORBITOL AND MANNITOLICU Medical Inc.5b44e248-4b7b-4777-954a-921c7b3099442025-10-30Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLICU Medical Inc.ba7bf864-8a4d-4262-8fd1-00174fa2f9d12025-10-24Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
QUALITY CHOICE Nausea ReliefSODIUM CITRATE DIHYDRATEQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)d89e41c1-399a-4157-8d54-bfefe3b1c1cd2025-10-01WarningsExact identifier
unii: B22547B95K
OsmitrolMANNITOLBaxter Healthcare Company0d914965-7001-45cb-ba51-d7c5964b05bc2025-08-26Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
InterSolPLATELET ADDITIVE 3Fenwal, Inc.17dec820-1b57-4ac9-82a8-419cab664a2f2025-06-27Warnings, Adverse reactionsExact identifier
unii: B22547B95K

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.