FDA.reportPublic FDA data

NDC 58468-0040-01 - 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
58468-0040
Requested NDC
58468-0040-01
Package NDCs from labels
58468-0040-1, 58468-0040-01
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
58468-0040-1Fabrazyme1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,135
58468-0040-1Fabrazyme7 mL in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,735

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58468-0040FABRAZYME (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
58468-0040-1EA - Each58468-0040835fb52d-bc09-4d09-8f57-b0eb38bf598f12012-07-24

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 4 of 10 · 194 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BM Nat PhosNATRUM PHOSPHORICUMBM Private Limited37b0db27-eede-9141-e063-6294a90a8a0c2025-12-02WarningsExact identifier
unii: 70WT22SF4B
BM Nat Phos Icing SugarNATRUM PHOSPHORICUM ICING SUGARBM Private Limited37c22e9a-375d-9018-e063-6294a90a2f562025-12-02WarningsExact identifier
unii: 70WT22SF4B
Candida HPBAPTISIA TINCTORIA ROOT, ECHINACEA PURPUREA, GLYCYRRHIZA GLABRA, ASTRAGALUS NUTTALLII LEAF, CANDIDA ALBICANS, SODIUM BORATE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, WOOD CREOSOTE, LYCOPODIUM CLAVATUM SPORE, STRYCHNOS NUX-VOMICA SEED, PHOSPHORIC ACID, ANEMONE PULSATILLA, SEPIA OFFICINALIS JUICE, THUJA OCCIDENTALIS LEAFY TWIG, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, NITRIC ACIDNatural Creations, Inc.b587a3f0-628b-41f7-8afb-2cdcd896279e2025-11-20WarningsExact identifier
unii: 70WT22SF4B
FleetSODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASICC.B. Fleet Company, Inc.c1677d70-203b-493e-88f0-815a66133f1d2025-11-20WarningsExact identifier
unii: 70WT22SF4B
Heartburn ReliefCARBO MORETRP Company14bd30e5-a981-597a-e054-00144ff8d46c2025-11-17WarningsExact identifier
unii: 70WT22SF4B
QR PAINANALGESICMARYHELENE ENTERPRISES INC8f8f53e3-fe31-e7b5-e053-2995a90a710d2025-11-14WarningsExact identifier
unii: 3OWL53L36A
QR PAINANALGESICMARYHELENE ENTERPRISES INC9984a510-30be-4013-e053-2995a90a841e2025-11-14WarningsExact identifier
unii: 3OWL53L36A
LUMO Booz Hangover CompaniionCHININUM ARSENICOSUM, NATRUM PHOSPHORICUM, NUX VOOMICA, VESPA CRABROApplied Bioenergetics, LLC8e23e541-2c78-4ca0-a61a-ad110665c7f32025-11-10WarningsExact identifier
unii: 70WT22SF4B
MannitolMANNITOLProPharma Distribution430669d7-9ad1-9a04-e063-6394a90ababb2025-11-07Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Ionosol MB and DextroseDEXTROSE MONOHYDRATE, SODIUM LACTATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, POTASSIUM PHOSPHATE, MONOBASIC, AND SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEICU Medical Inc.1b457b1d-0e80-4578-ba6f-dedf513fc9622025-10-30Warnings, Adverse reactionsExact identifier
unii: 593YOG76RN
Sorbitol-MannitolSORBITOL AND MANNITOLICU Medical Inc.5b44e248-4b7b-4777-954a-921c7b3099442025-10-30Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLICU Medical Inc.ba7bf864-8a4d-4262-8fd1-00174fa2f9d12025-10-24Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Miranda Castros Phosphorus 5 Cell Salts For Physical and Emotional Fatigue, Stress and TensionCALCAREA PHOS, FERRUM PHOS, KALI PHOS, MAGNESIUM PHOS, NATRUM PHOSMIRANDA CASTRO'S SHOP, LLC2670fdeb-0c80-9f23-e063-6394a90a8c6a2025-10-23WarningsExact identifier
unii: 70WT22SF4B
Me NaPhos MB Hyo 1URINARY ANTISEPTIC ANTISPASMODICMethod Pharmaceuticals2ae628e7-3b33-6a9a-e054-00144ff8d46c2025-10-21Warnings, Adverse reactionsExact identifier
unii: 593YOG76RN
OsmitrolMANNITOLBaxter Healthcare Company0d914965-7001-45cb-ba51-d7c5964b05bc2025-08-26Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
FabrazymeAGALSIDASE BETAGenzyme Corporation988513ab-b06f-4dd0-93f7-d2d4531dcce42025-08-22Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA103979
ndc (package): 58468-0040-1
ndc (package): 58468-0041-1
ndc (product): 58468-0040
ndc (product): 58468-0041
ndc11 (package): 58468004001
rxcui: 1804762
rxcui: 1804755
rxcui: 1804758
rxcui: 1804760
spl id: 9b786f81-f4d8-4bc6-8f5f-68adbbfb60d1
spl set id: 988513ab-b06f-4dd0-93f7-d2d4531dcce4
unii: RZD65TSM9U
Sodium PhosphatesSODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE AND SODIUM PHOSPHATE, DIBASIC ANHYDROUSCivica, Inc.8fd901e6-30cb-411a-b820-b9e79625ec7c2025-08-08Warnings, Adverse reactionsExact identifier
unii: 593YOG76RN
Cell SaltsCALC. FLUOR., CALC. PHOS., CALC.SULPH., FERRUM PHOSPHORICUM, KALI MUR., KALI PHOS., KALI SULPH., MAG. PHOS., NAT. MUR., NAT. PHOS., NAT.SULPHURICUM, SILICEANewton Laboratories, Inc.985a3341-0fe0-1dd6-e053-2a95a90ad2c52025-07-25WarningsExact identifier
unii: 70WT22SF4B
Cell SaltsCALC. FLUOR., CALC. PHOS., CALC.SULPH., FERRUM PHOSPHORICUM, KALI MUR., KALI PHOS., KALI SULPH., MAG. PHOS., NAT. MUR., NAT. PHOS., NAT.SULPHURICUM, SILICEANewton Laboratories, Inc.7a1b4e96-c96f-6424-e053-2991aa0aef302025-07-24WarningsExact identifier
unii: 70WT22SF4B
Cell SaltsCALC. FLUOR., CALC. PHOS., CALC.SULPH., FERRUM PHOSPHORICUM, KALI MUR., KALI PHOS., KALI SULPH., MAG. PHOS., NAT. MUR., NAT. PHOS., NAT.SULPHURICUM, SILICEANewton Laboratories, Inc.7a1a9ef9-9a54-5f94-e053-2a91aa0ab4772025-07-24WarningsExact identifier
unii: 70WT22SF4B

Reported adverse events (FAERS/openFDA)#

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