cerezyme

Generic: imiglucerase

Labeler: genzyme corporation
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name cerezyme
Generic Name imiglucerase
Labeler genzyme corporation
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

imiglucerase 40 U/mL

Manufacturer
Genzyme Corporation

Identifiers & Regulatory

Product NDC 58468-4663
Product ID 58468-4663_6a32f852-ba91-4185-a618-0ba55a14442e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA020367
Listing Expiration 2027-12-31
Marketing Start 1994-05-23

Pharmacologic Class

Established (EPC)
hydrolytic lysosomal glucocerebroside-specific enzyme [epc]
Chemical Structure
glucosylceramidase [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 584684663
Hyphenated Format 58468-4663

Supplemental Identifiers

RxCUI
1726266 1726268
UNII
Q6U6J48BWY
NUI
M0009360 N0000175820

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name cerezyme (source: ndc)
Generic Name imiglucerase (source: ndc)
Application Number BLA020367 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 40 U/mL
source: ndc
Packaging
  • 1 VIAL, GLASS in 1 CARTON (58468-4663-1) / 10 mL in 1 VIAL, GLASS
source: ndc

Packages (1)

58468-4663-1 1 VIAL, GLASS in 1 CARTON (58468-4663-1) / 10 mL in 1 VIAL, GLASS

Ingredients (1)

imiglucerase (40 U/mL)

Linked Drug Pages (1)

Cerezyme ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "6a32f852-ba91-4185-a618-0ba55a14442e", "openfda": {"nui": ["M0009360", "N0000175820"], "unii": ["Q6U6J48BWY"], "rxcui": ["1726266", "1726268"], "spl_set_id": ["df60f030-866b-4374-a31f-8ae3f6b45c38"], "pharm_class_cs": ["Glucosylceramidase [CS]"], "pharm_class_epc": ["Hydrolytic Lysosomal Glucocerebroside-specific Enzyme [EPC]"], "manufacturer_name": ["Genzyme Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 CARTON (58468-4663-1)  / 10 mL in 1 VIAL, GLASS", "package_ndc": "58468-4663-1", "marketing_start_date": "19940523"}], "brand_name": "Cerezyme", "product_id": "58468-4663_6a32f852-ba91-4185-a618-0ba55a14442e", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Glucosylceramidase [CS]", "Hydrolytic Lysosomal Glucocerebroside-specific Enzyme [EPC]"], "product_ndc": "58468-4663", "generic_name": "IMIGLUCERASE", "labeler_name": "Genzyme Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cerezyme", "active_ingredients": [{"name": "IMIGLUCERASE", "strength": "40 U/mL"}], "application_number": "BLA020367", "marketing_category": "BLA", "marketing_start_date": "19940523", "listing_expiration_date": "20271231"}