Package 58468-4663-1
Brand: cerezyme
Generic: imiglucerasePackage Facts
Identity
Package NDC
58468-4663-1
Digits Only
5846846631
Product NDC
58468-4663
Description
1 VIAL, GLASS in 1 CARTON (58468-4663-1) / 10 mL in 1 VIAL, GLASS
Marketing
Marketing Status
Brand
cerezyme
Generic
imiglucerase
Sample Package
No
Linked Drug Pages (1)
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"}