FDA.reportPublic FDA data

NDC 58468-0160-01 - Lumizyme

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
58468-0160
Requested NDC
58468-0160-01
Package NDCs from labels
58468-0160-1, 58468-0160-2, 58468-0160-01
Manufacturer
Genzyme Corporation | Genzyme Flanders | Genzyme Ireland Limited | Eurofins Biopharma Product Testing Ireland Limited
Effective date
2025-01-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
LumizymeGenzyme Corporation | Genzyme Flanders | Genzyme Ireland Limited | Eurofins Biopharma Product Testing Ireland Limited2025-01-10HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58468-0160-1Lumizyme10.5 mL in 1 VIAL, SINGLE-USEINJECTION, POWDER, FOR SOLUTION10.521
58468-0160-1Lumizyme1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION121
58468-0160-2Lumizyme10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION1021
58468-0160-2Lumizyme10.5 mL in 1 VIAL, SINGLE-USEINJECTION, POWDER, FOR SOLUTION10.521

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58468-0160LUMIZYME (ALGLUCOSIDASE ALFA) INJECTION, POWDER, FOR SOLUTION [GENZYME CORPORATION]21Current NDC, Legacy NDC, 4 package rows20250112_d6bfbc45-2d34-439e-8aad-59ee2d53d4df.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58468-0160-1EA - Each58468-01600669f375-6a12-4b35-b24c-06dbe9d77cd112012-07-24
58468-0160-2EA - Each58468-0160e2f69a41-9a95-4663-86fb-415cdb1ca75312014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALGLUCOSIDASE ALFAACTIVE INGREDIENTDTI67O9503LUMIZYME (ALGLUCOSIDASE ALFA) INJECTION, POWDER, FOR SOLUTION [GENZYME CORPORATION]8
ALGLUCOSIDASE ALFAACTIVE MOIETYDTI67O9503LUMIZYME (ALGLUCOSIDASE ALFA) INJECTION, POWDER, FOR SOLUTION [GENZYME CORPORATION]8
MANNITOLINACTIVE INGREDIENT3OWL53L36ALUMIZYME (ALGLUCOSIDASE ALFA) INJECTION, POWDER, FOR SOLUTION [GENZYME CORPORATION]8
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HLUMIZYME (ALGLUCOSIDASE ALFA) INJECTION, POWDER, FOR SOLUTION [GENZYME CORPORATION]8
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEINACTIVE INGREDIENT70WT22SF4BLUMIZYME (ALGLUCOSIDASE ALFA) INJECTION, POWDER, FOR SOLUTION [GENZYME CORPORATION]8
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEINACTIVE INGREDIENT593YOG76RNLUMIZYME (ALGLUCOSIDASE ALFA) INJECTION, POWDER, FOR SOLUTION [GENZYME CORPORATION]8

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 3 of 11 · 203 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BIO COM 25 ACIDITYNAT PHOS, NAT SULPH, SILICEABM Private Limited3b3c3455-b321-071d-e063-6394a90a01602026-02-17WarningsExact identifier
unii: 70WT22SF4B
Additive Formula 3DEXTROSE MONOHYDRATE, TRISODIUM CITRATE DIHYDRATE, SODIUM CHLORIDE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, CITRIC ACID MONOHYDRATE, AND ADENINETerumo BCT, Ltd9a5247a1-cc05-442d-b2d0-950f887f03c22026-01-30Warnings, Adverse reactionsExact identifier
unii: 593YOG76RN
HeilenGALIUM APARINE, AGNUS CASTUS, APIS MELLIFICA, CAPSICUM ANNUUM, CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, URTICA DIOICA, XANTHOXYLUM FRAXINEUM, FUCUS VESICULOSUS, KALI PHOSPHORICUM, MAGNESIA PHOSPHORICA, NATRUM PHOSPHORICUM, SARSAPARILLA (SMILAX REGELII), UBIDECARENONUM, CALCAREA CARBONICA, GRAPHITES, LYCOPODIUM CLAVATUM, ANACARDIUM ORIENTALE, COLCHICUM AUTUMNALE, NUX VOMICA, PHYTOLACCA DECANDRA, PULSATILLA (PRATENSIS), HISTAMINUM HYDROCHLORICUMHeilenef3f66f9-47bc-4fce-8950-ed2319bc30d62026-01-12WarningsExact identifier
unii: 70WT22SF4B
Ulcer Drops 2094ULCER DROPSProfessional Complementary Health Formulas92cfc484-e3bc-4f04-a06a-3299c8522e322026-01-08WarningsExact identifier
unii: 70WT22SF4B
Stomach Enzyme Drops 2093STOMACH ENZYME DROPSProfessional Complementary Health Formulas5852af9f-2e9c-413c-aad8-7688e2626f1c2026-01-08WarningsExact identifier
unii: 70WT22SF4B
RET Small Intestine 7010RET SMALL INTESTINEProfessional Complementary Health Formulas0be84681-1dd1-46bf-96ec-e7cde89ab31d2026-01-08WarningsExact identifier
unii: 70WT22SF4B
Cell Salt Combination 8013CELL SALT COMBINATIONProfessional Complementary Health Formulasb3a33345-3c3d-4f86-ae4d-757c65fd1ed32026-01-08WarningsExact identifier
unii: 70WT22SF4B
Natrum Phosphoricum 8010NATRUM PHOSPHORICUMProfessional Complementary Health Formulas185227a3-69fa-4ada-af23-15dbe34ed7452026-01-08WarningsExact identifier
unii: 70WT22SF4B
RET Liver 7008RET LIVERProfessional Complementary Health Formulasd81bdbbd-5cfa-40e3-99f5-fd5368239fbe2026-01-08WarningsExact identifier
unii: 70WT22SF4B
Sixth Chakra (Third Eye) 7306SIXTH CHAKRA (THIRD EYE)Professional Complementary Health Formulas174024e7-e231-456c-bc00-48a358d7160a2026-01-08WarningsExact identifier
unii: 70WT22SF4B
Third Chakra (Solar Plexus) 7303THIRD CHAKRA (SOLAR PLEXUS)Professional Complementary Health Formulaseea89c37-ab87-4cc7-8dfc-e7f42a580dd92026-01-08WarningsExact identifier
unii: 70WT22SF4B
emotional detoxCALC PHOS, CALC SULPH, CASTANEA SATIVA, FLOS, ILEX AQUIFOLIUM, FLOS, KALI PHOS, NAT MUR, NAT PHOS, NAT SULPH, OLEA EUROPAEA, FLOS, ORNITHOGALUM UMBELLATUM, FLOSSiddha Flower Essences LLC385fb878-dd8f-40ae-82a3-874d6a6cceb22025-12-31WarningsExact identifier
unii: 70WT22SF4B
healthy hairCERTOSTIGMA WILLMOTTIANUM, FLOS, KALI SULPH, LARIX DECIDUA, FLOS, MIMULUS GUTTATUS, FLOS, NAT MUR, NAT PHOS, SILICEASiddha Flower Essences LLC2b49fb7a-8d8b-4cef-8f8d-515c54451bfd2025-12-31WarningsExact identifier
unii: 70WT22SF4B
energy and motivationCALC SULPH, GENTIANA AMARELLA FLOS, KALI PHOS, NAT MUR, NAT PHOS, NAT SULPH, OLEA EUROPEA FLOS, PHOS ACID, ULEX EUROPAEUS FLOSSiddha Flower Essences LLCaa69dd35-9866-40d7-9820-b01fc15be58a2025-12-31WarningsExact identifier
unii: 70WT22SF4B
male balanceCENTARIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, KALI PHOS, LARIX DECIDUA, FLOS, LYCOPODIUM, NAT MUR, NAT PHOS, SILICEASiddha Flower Essences LLC61b7cfe0-1465-482b-97dd-8fbb8d420a932025-12-31WarningsExact identifier
unii: 70WT22SF4B
muscles and jointsCALC FLUOR, CALC PHOS, CARPINUS BETULUS, FLOS, ILEX AQUIFOLIUM, FLOS, KALI SULPH, MAG PHOS, NAT PHOS, QUERCUS ROBUR, FLOS, SILICEASiddha Flower Essences LLC421e61e4-f9df-48e1-bff3-80148a5de5cf2025-12-31WarningsExact identifier
unii: 70WT22SF4B
Pall Sterile Cord Blood Collection UnitSTERILE CORD BLOOD COLLECTION UNITGlobal Life Sciences Solutions USA LLCaa9340b7-cc63-e17d-e053-2a95a90ad4d92025-12-18WarningsExact identifier
unii: 593YOG76RN
Uretron D/SMETHENAMINE, SODIUM PHOSPHATE MONOBASIC, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATEDORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticalsea74f1aa-2b4d-4ccf-e053-2995a90abab52025-12-18Warnings, Adverse reactionsExact identifier
unii: 593YOG76RN
VermasodeARTEMISIA VULGARIS, CHELIDONIUM MAJUS, GRANATUM, SPIGELIA ANTHELMIA, RATANHIA, ARSENICUM ALBUM, FERRUM METALLICUM, CALCAREA CARBONICA, CINA, GAERTNER BACILLUS, GRAPHITES, MERCURIUS DULCIS, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, VERMIN NOSODENatural Creations, Inc180b5641-5692-42d4-8472-fdadccebd7462025-12-18WarningsExact identifier
unii: 70WT22SF4B
GB-ToneAMMI VIS, ATROPINUM SULPHURICUM, BOLDO, CARDUUS MAR, CHELIDONIUM MAJ, ECHINACEA, FEL TAURI, HEPAR SUIS, HYDRASTIS, LEPTANDRA, MAG PHOS, NAT PHOS, PODOPH PELT, TARAXACUMEnergetix Corporation1d857ae7-ad24-4f3b-8c33-f52851fa1ce62025-12-17WarningsExact identifier
unii: 70WT22SF4B

Reported adverse events (FAERS/openFDA)#

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