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 2 of 4 · 63 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nauzene Chewables Ginger HoneySODIUM CITRATEKobayashi Healthcare International, Inc.25c9825d-a4e8-4671-e063-6294a90ab46d2025-06-24WarningsExact identifier
unii: B22547B95K
MannitolMANNITOLHenry Schein, Inc.e2444db1-9dfe-451f-a33c-9b00786464d22025-05-20Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
NauzeneSODIUM CITRATEKobayashi Healthcare International, Inc.a60660b2-c5db-45a0-885f-de93e655380d2025-04-29WarningsExact identifier
unii: B22547B95K
Sodium Citrate w/v AnticoagulantTRISODIUM CITRATE DIHYDRATETerumo BCT, Ltdc9d0e9c8-379f-4895-b272-329efab575c42025-01-24Warnings, Adverse reactionsExact identifier
unii: B22547B95K
Sodium Citrate 4% w/v AnticoagulantTRISODIUM CITRATE DIHYDRATETerumo BCT, Ltd0775912f-f14a-4967-ac00-c8c1b36040bf2025-01-23Warnings, Adverse reactionsExact identifier
unii: B22547B95K
Emetrol Powder Non-DrowsySODIUM CITRATE DIHYDRATEWellSpring Pharmaceutical Corporation9d8d2ee7-9db7-4be7-8c73-511eb2e324592025-01-08WarningsExact identifier
unii: B22547B95K
teruflex blood bag system with diversion blood sampling arm 70 ml cpda-1ANHYDROUS CITRIC ACID, TRISODIUM CITRATE DIHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, DEXTROSE MONOHYDRATE, AND ADENINETerumo Corporation86b3a329-c83f-4977-92f5-0e9dfe1872d72024-10-10WarningsExact identifier
unii: B22547B95K
TERUFLEX BLOOD with Diversion Blood Sampling Arm 70 mL CPDA-1ANHYDROUS CITRIC ACID, TRISODIUM CITRATE DIHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, DEXTROSE MONOHYDRATE, AND ADENINETerumo Corporation39f2e11c-5a31-469f-b725-d096c16744212024-10-03WarningsExact identifier
unii: B22547B95K
TERUFLEX Blood Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) for Collection of 450mL of BloodANHYDROUS CITRIC ACID, TRISODIUM CITRATE DIHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, DEXTROSE MONOHYDRATE, AND ADENINETerumo Corporation02015040-9b71-4dbe-8f8d-e0d0951e8f932024-09-19WarningsExact identifier
unii: B22547B95K
ANTICOAGULANT SODIUM CITRATETRISODIUM CITRATE DIHYDRATEBaxter Healthcare Corporation7025a0f9-1a56-4416-a3a4-925d755aed902024-04-02Exact identifier
unii: B22547B95K
MANNITOLMANNITOLHF Acquisition Co LLC, DBA HealthFirst999ce711-2d5b-0d7d-e053-2995a90a26892024-01-27Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
OracitCITRIC ACID AND SODIUM CITRATECMP Pharma, Inc.bc26abed-8e6e-475d-8ab3-abf7d03770032023-12-07Adverse reactionsExact identifier
unii: B22547B95K
MannitolMANNITOLB. Braun Medical Inc.d12cc802-b538-4065-a264-f474ff3b30432023-08-15Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Emetrol Chewables Mixed BerrySODIUM CITRATE DIHYDRATEWellSpring Pharmaceutical Corporation4965fab0-828d-4f1d-8d43-a636e0a8c1ea2023-03-23WarningsExact identifier
unii: B22547B95K
Emetrol Chewables OrangeSODIUM CITRATE DIHYDRATEWellSpring Pharmaceutical Corporatione9072f9d-d74c-4e43-bcfe-ee005577df352023-03-23WarningsExact identifier
unii: B22547B95K
MannitolMANNITOLFresenius Kabi USA, LLCc395e13d-6ea1-4104-8b37-669cfb982f042023-03-16Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
triCitrasolTRISODIUM CITRATE DIHYDRATECitra Labs LLC64e7652c-1437-43bd-8ea2-3cafab447b8c2023-02-14Warnings, Adverse reactionsExact identifier
unii: B22547B95K
Anticoagulant Citrate Dextrose AANHYDROUS CITRIC ACID, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATECitra Labs LLC5bcd261e-ebba-4ecb-af22-e5aaeb04499b2023-02-14Warnings, Adverse reactionsExact identifier
unii: B22547B95K
Refresh Digital PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80Allergan, Inc.97e83e68-6374-4df4-93f6-d707fc32748d2022-11-28WarningsExact identifier
unii: 6OZP39ZG8H
Refresh DigitalCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.b2bd34d4-fab9-4f4b-9be2-5d30b55f5b812022-11-28WarningsExact identifier
unii: 6OZP39ZG8H

Reported adverse events (FAERS/openFDA)#

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