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 7 of 9 · 176 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Natrum phosphoricumSODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEBoiron86472dc7-5d6a-c3bc-e053-2a91aa0a0e632023-11-14Exact identifier
unii: 70WT22SF4B
VermistatARTEMISIA VULGARIS, CINA, SABADILLA, SPIGELIA ANTHELMIA, FILIX MAS, BARYTA CARBONICA, CALCAREA CARBONICA, CINCHONA OFFICINALIS, NATRUM PHOSPHORICUM, SULPHUR, TEREBINTHINA, PROTEUS (VULGARIS)Energique, Inc.acb43b1a-52fd-484b-96a8-1cfe97c1f3982023-11-02WarningsExact identifier
unii: 70WT22SF4B
MetabCALCAREA SULPHURICA, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, CEREBELLUM (SUIS), GALLBLADDER (BOVINE), HEART (BOVINE), HEPAR (BOVINE), HYPOTHALAMUS SUIS, INTESTINE (SUIS), KIDNEY (BOVINE), LUNG (BOVINE), MEDULLA OSSIS SUIS, PANCREAS SUIS, PINEAL GLAND (SUIS), RECTAL MUCOSA (SUIS), SPLEEN (BOVINE), STOMACH (SUIS), THYMUS (OVINE), THYROIDINUM (BOVINE), URINARY BLADDER (SUIS), PITUITARUM POSTERIUM (BOVINE), ACETYL COENZYME A,Nutritional Specialties, Inc.bbed9973-238f-47c5-9a50-ac0869a7eb3a2023-10-09WarningsExact identifier
unii: 70WT22SF4B
Stomach Enzyme FormulaBETAINUM MURIATICUM, MURIATICUM ACIDUM, NATRUM PHOSPHORICUM, PANCREAS SUIS, STOMACH (SUIS) SYMPHYTUM OFFICINALE, PEPSINUMNutritional Specialties, Inc.992e6f61-abc9-4146-a9da-5ada4a627aa72023-10-04WarningsExact identifier
unii: 70WT22SF4B
Uric Acid BalancerDULCAMARA, LEDUM PALUSTRE, ARNICA MONTANA, BENZOICUM ACIDUM, BRYONIA (ALBA), COLCHICUM AUTUMNALE, LITHIUM CARBONICUM, NATRUM PHOSPHORICUM, URTICA URENS, FORMICA RUFA, LYCOPODIUM CLAVATUMNutritional Specialties, Inc.f46c8203-4022-4240-bb45-2a3a8a318eae2023-10-04WarningsExact identifier
unii: 70WT22SF4B
Natrum phosphoricumSODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEBoiron864786c9-09bb-e8c8-e053-2a91aa0a7e1b2023-08-29Exact identifier
unii: 70WT22SF4B
Natrum phosphoricumSODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEBoiron8647b54a-3332-4ad3-e053-2991aa0a2b042023-08-29Exact identifier
unii: 70WT22SF4B
MannitolMANNITOLB. Braun Medical Inc.d12cc802-b538-4065-a264-f474ff3b30432023-08-15Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
CellergyCALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, FERRUM PHOSPHORICUM, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, SILICEA.Ratis, LLC2aebc11e-eeb7-436b-b90c-3a2f59fb74922023-08-07WarningsExact identifier
unii: 70WT22SF4B
Natrum phosphoricumSODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEBoiron8646d2ee-3c9e-71f7-e053-2991aa0ae9c12023-04-11Exact identifier
unii: 70WT22SF4B
MannitolMANNITOLFresenius Kabi USA, LLCc395e13d-6ea1-4104-8b37-669cfb982f042023-03-16Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
K Phos NeutralSODIUM PHOSPHATE, DIBASIC, ANHYDROUS, POTASSIUM PHOSPHATE, MONOBASIC, AND SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEBeach Products, Inc.83376725-ee0f-40ad-bd90-31a61b9445cf2023-02-23Adverse reactionsExact identifier
unii: 593YOG76RN
Natrum phosphoricumSODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEBoiron12e87e30-7c60-11e6-869d-424c583030312023-02-20Exact identifier
unii: 70WT22SF4B
RejuvesolSODIUM PYRUVATE, INOSINE, ADENINE, SODIUM PHOSPHATE, DIBASIC, AND SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATECitra Labs, LLCbc06c40f-81a0-45e5-80b6-61f67d4450682023-02-14WarningsExact identifier
unii: 593YOG76RN
Nat PhosSODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEHyland's Inc.d3ac00f2-590b-7185-e053-2a95a90a3f4a2022-12-13WarningsExact identifier
unii: 70WT22SF4B
CALMS FORTEAVENA SATIVA FLOWERING TOP, TRIBASIC CALCIUM PHOSPHATE, MATRICARIA RECUTITA, FERROSOFERRIC PHOSPHATE, HOPS, POTASSIUM PHOSPHATE, DIBASIC, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, AND PASSIFLORA INCARNATA FLOWERHyland's Inc.f48a35d4-aa0c-48b1-a2ad-a614ea2894e82022-12-07WarningsExact identifier
unii: 70WT22SF4B
Natrum PhosphoricumNATRUM PHOSPHORICUMHahnemann Laboratories, INC.ed01509a-afb6-476f-e053-2995a90a5aa62022-11-08Exact identifier
unii: 70WT22SF4B
Anticoagulant Citrate Phosphate Dextrose (CPD) Blood-Pack Units in PL 146 PlasticANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) SOLUTIONFenwal, Inc.d55cb701-9664-4931-8754-1a8cae68da062022-11-01Exact identifier
unii: 593YOG76RN
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE (CPDA-1) SOLUTIONFenwal, Inc.f9d7f1b4-7a77-44f9-8924-10b16008b49d2022-11-01Exact identifier
unii: 593YOG76RN
Anticoagulant Citrate Phosphate Dextrose (CPD) Blood-Pack Units in PL 146 PlasticANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD)Fenwal, Inc.4a08a9ec-46a5-4fcf-80ee-5c33f1a8b7462022-11-01Exact identifier
unii: 593YOG76RN

Reported adverse events (FAERS/openFDA)#

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