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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2025-08-19	These 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
2025-08-19	These 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
2025-07-29	These 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
2025-07-29	These 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 NDC	Product	Description	Form	Quantity	Strength	SPL version
58468-4663-1	Cerezyme	10 mL in 1 VIAL, GLASS	INJECTION, POWDER, LYOPHILIZED,	10		26
58468-4663-1	Cerezyme	1 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	1		26

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58468-4663	CEREZYME (IMIGLUCERASE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENZYME CORPORATION]	24	Current NDC, Legacy NDC, 2 package rows	20250101_df60f030-866b-4374-a31f-8ae3f6b45c38.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
58468-4663-1	EA - Each	58468-4663	43197b45-0156-4563-a8a8-6f5d6dc57590	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
IMIGLUCERASE	ACTIVE INGREDIENT	Q6U6J48BWY	CEREZYME (IMIGLUCERASE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENZYME CORPORATION]	7
IMIGLUCERASE	ACTIVE MOIETY	Q6U6J48BWY	CEREZYME (IMIGLUCERASE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENZYME CORPORATION]	7
DISODIUM HYDROGEN CITRATE	INACTIVE INGREDIENT	6FO62KCQ7A	CEREZYME (IMIGLUCERASE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENZYME CORPORATION]	7
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	CEREZYME (IMIGLUCERASE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENZYME CORPORATION]	7
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	CEREZYME (IMIGLUCERASE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENZYME CORPORATION]	7
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	CEREZYME (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 4 of 4 · 63 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Join
CPDA-1	ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE	Fenwal, Inc.	5c7d3287-883a-459b-9214-074a583c8a59	2019-11-18	Exact identifier unii: B22547B95K
CPDA-1	ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE	Fenwal, Inc.	448a1dc5-7a98-4b2f-82af-4b92de05cfc3	2019-11-18	Exact identifier unii: B22547B95K
CPDA-1	ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE	Fenwal, Inc.	051f7347-5a76-4664-8fe2-e61b3dfcb0e4	2014-08-27	Exact identifier unii: B22547B95K

Reported adverse events (FAERS/openFDA)#

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