FDA.reportPublic FDA data

NDC 58468-0041-01 - Fabrazyme

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
58468-0041
Requested NDC
58468-0041-01
Package NDCs from labels
58468-0041-1, 58468-0041-01
Manufacturer
Genzyme Corporation | Genzyme Ireland Limited
Effective date
2025-08-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Fabrazyme - Genzyme Corporation | Genzyme Ireland LimitedGenzyme Corporation | Genzyme Ireland Limited2025-08-22HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2025-08-22These highlights do not include all the information needed to use FABRAZYME ® safely and effectively. See full prescribing information for FABRAZYME ® . FABRAZYME ® (agalsidase beta) for injection, for intravenous use Initial U.S. Approval: 2003
2025-07-29These highlights do not include all the information needed to use FABRAZYME ® safely and effectively. See full prescribing information for FABRAZYME ® . FABRAZYME ® (agalsidase beta) for injection, for intravenous use Initial U.S. Approval: 2003
2023-08-07These highlights do not include all the information needed to use FABRAZYME ® safely and effectively. See full prescribing information for FABRAZYME ® . FABRAZYME ® (agalsidase beta) for injection, for intravenous use Initial U.S. Approval: 2003
2023-07-28These highlights do not include all the information needed to use FABRAZYME ® safely and effectively. See full prescribing information for FABRAZYME ® . FABRAZYME ® (agalsidase beta) for injection, for intravenous use Initial U.S. Approval: 2003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58468-0041-1Fabrazyme1 mL in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,135
58468-0041-1Fabrazyme1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,135

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58468-0041FABRAZYME (AGALSIDASE BETA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENZYME CORPORATION]34Current NDC, Legacy NDC, 2 package rows20240718_988513ab-b06f-4dd0-93f7-d2d4531dcce4.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58468-0041-1EA - Each58468-0041064c6fe9-ec85-4057-baa6-b19ea2564ba112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AGALSIDASE BETAACTIVE INGREDIENTRZD65TSM9UFABRAZYME (AGALSIDASE BETA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENZYME CORPORATION]17
AGALSIDASE BETAACTIVE MOIETYRZD65TSM9UFABRAZYME (AGALSIDASE BETA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENZYME CORPORATION]17
MANNITOLINACTIVE INGREDIENT3OWL53L36AFABRAZYME (AGALSIDASE BETA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENZYME CORPORATION]17
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEINACTIVE INGREDIENT70WT22SF4BFABRAZYME (AGALSIDASE BETA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENZYME CORPORATION]17
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEINACTIVE INGREDIENT593YOG76RNFABRAZYME (AGALSIDASE BETA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENZYME CORPORATION]17

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 5 of 9 · 176 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ParasodeARTEMISIA VULGARIS ROOT, CHELIDONIUM MAJUS WHOLE, PUNICA GRANATUM ROOT BARK, SPIGELIA ANTHELMIA WHOLE, KRAMERIA LAPPACEA ROOT, ARSENIC TRIOXIDE, IRON, OYSTER SHELL CALCIUM CARBONATE, CRUDE, ARTEMISIA CINA PRE-FLOWERING TOP, SALMONELLA ENTERICA ENTERICA SEROVAR ENTERITIDIS, GRAPHITE, CALOMEL, SODIUM CHLORIDE, AND SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEZorex0ed722dc-cd25-4a15-b3f8-052cc7bcd9ec2025-07-01WarningsExact identifier
unii: 70WT22SF4B
InterSolPLATELET ADDITIVE 3Fenwal, Inc.17dec820-1b57-4ac9-82a8-419cab664a2f2025-06-27Warnings, Adverse reactionsExact identifier
unii: 593YOG76RN
MannitolMANNITOLHenry Schein, Inc.e2444db1-9dfe-451f-a33c-9b00786464d22025-05-20Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Bestmade Natural Products BM213GRAPHITES, RHUS TOX, NATRUM SULPH, CARBO VEG, NAT PHOSBestmade Natural Products2f6d9587-7185-7fef-e063-6394a90aa6fd2025-03-03WarningsExact identifier
unii: 70WT22SF4B
MB CAPSMETHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATEAllegis Pharmaceuticals, LLC2efeb281-b84b-4750-e063-6394a90a27ee2025-02-25Warnings, Adverse reactionsExact identifier
unii: 593YOG76RN
Natrum Phosphoricum 6XNATRUM PHOSPHORICUMSEVENE USAff0d77ad-3e04-25ea-e053-6294a90a0def2025-02-11WarningsExact identifier
unii: 70WT22SF4B
12 CELL SALTS COMPLEXCALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, FERRUM PHOSPHORICUM, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, SILICEASEVENE USAff0f69cd-97a2-7183-e053-6394a90ad0392025-02-10WarningsExact identifier
unii: 70WT22SF4B
Jacksons Cell Salts 12 IN 1CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEAZettl Health Inc.25ba49d0-0369-3666-e063-6294a90a71c42025-02-04Exact identifier
unii: 70WT22SF4B
Jacksons Cell Salts NAT PHOS 6X 10NATRUM PHOSPHORICUMZettl Health Inc.2d5cf8f3-2bdb-b489-e063-6394a90abce32025-02-04Exact identifier
unii: 70WT22SF4B
Bestmade Natural Products BM55DAPHNE INDICA, NATRUM PHOS, SILICA MARINA, TABACUMBestmade Natural Products2c751942-5b36-8558-e063-6294a90af87a2025-01-24WarningsExact identifier
unii: 70WT22SF4B
D-85HYDRANGEA ARBORESCENS ROOT, SAW PALMETTO, CORN SILK, ELYMUS REPENS ROOT, AGATHOSMA CRENULATA LEAF, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, AND DIBASIC POTASSIUM PHOSPHATEDNA Labs, Inc.83f43207-76bb-4fc0-b3fc-45614da43e232025-01-13WarningsExact identifier
unii: 70WT22SF4B
D-130SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEDNA Labs, Inc.9d89f6ea-c1cc-49b1-acbc-f388659043a22025-01-13WarningsExact identifier
unii: 70WT22SF4B
D-106BETAINE HYDROCHLORIDE, BOS TAURUS BILE, PANCRELIPASE LIPASE, BEEF LIVER, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, BOS TAURUS PANCREAS, PEPSIN, AND SUS SCROFA STOMACHDNA Labs, Inc.c032c034-c58b-4287-b78c-37fab1feb4252025-01-13WarningsExact identifier
unii: 70WT22SF4B
D-133CALCIUM FLUORIDE, SILICON DIOXIDE, TRIBASIC CALCIUM PHOSPHATE, CALCIUM SULFATE ANHYDROUS, FERROSOFERRIC PHOSPHATE, POTASSIUM CHLORIDE, DIBASIC POTASSIUM PHOSPHATE, POTASSIUM SULFATE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, SODIUM CHLORIDE, AND SODIUM SULFATEDNA Labs, Inc.a250b7e9-7fd2-4cb0-82f3-baa089d174412025-01-13WarningsExact identifier
unii: 70WT22SF4B
D-139ARSENICUM ALBUM, BELLADONNA, CALCAREA CARBONICA, CARBO VEGETABILIS, FERRUM PHOSPHORICUM, LYCOPODIUM, NATRUM PHOSPHORICUM, NUX VOMICA, PHOSPHORUS, PULSATILLA, HYDRASTISDNA Labs, Inc.e830774e-35c8-7309-e053-2995a90ae0432025-01-13WarningsExact identifier
unii: 70WT22SF4B
AM-7STRYCHNOS NUX-VOMICA SEED, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, AND BUFO BUFO WHOLEDNA Labs, Inc.c913d2ca-dd24-4139-b61b-2c1d267cc4e82025-01-09WarningsExact identifier
unii: 70WT22SF4B
N-16MGO ENERGIZERDNA Labs, Inc.8292b900-86c1-47ea-81da-b587439c76642025-01-09WarningsExact identifier
unii: 70WT22SF4B
N-24METABOLINDNA Labs, Inc.559fca2b-1093-4bdf-be70-c453f87002c32025-01-09WarningsExact identifier
unii: 70WT22SF4B
URIMAR-T CAPSMETHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATEAllegis Pharmaceuticals, LLCcf7c3d65-11d2-49cd-b207-8ccc6a221fe02025-01-08Warnings, Adverse reactionsExact identifier
unii: 593YOG76RN
Trace Mineral CordARGENTUM METALLICUM, AURUM METALLICUM, BORON CITRATE, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, CHROMIUM SULPHURICUM, COBALT GLUCONATE, CUPRUM SULPHURICUM, FERRUM PHOSPHORICUM, GERMANIUM SESQUIOXIDE, IODIUM, KALI BROMATUM, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, LITHIUM CARBONICUM, MAGNESIA PHOSPHORICA, MANGANUM MURIATICUM, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, SELENIUM METALLICUM, SILICEA, SODIUM MOLYBDATE, STRONTIUM CARBONICUM, VANADIUM METALLICUM,Energique, Inc.902dd68d-5ce1-481e-8938-6487dcc68dfc2024-12-19WarningsExact identifier
unii: 70WT22SF4B

Reported adverse events (FAERS/openFDA)#

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