NDC 58468-0357-01 - Campath

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
58468-0357
Requested NDC
58468-0357-01
Package NDCs from labels
58468-0357-1, 58468-0357-3, 58468-0357-01
Manufacturer
Genzyme Corporation | Boehringer Ingelheim Pharma GmbH & Co. KG | Sanofi-Aventis Deutschland GmbH | HVL Pharma UK Limited
Effective date
2025-11-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
CampathGenzyme Corporation | Boehringer Ingelheim Pharma GmbH & Co. KG | Sanofi-Aventis Deutschland GmbH | HVL Pharma UK Limited2025-11-05HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58468-0357-1Campath1 in 1 CARTONINJECTION121
58468-0357-1Campath1 mL in 1 VIAL, SINGLE-USEINJECTION121
58468-0357-3Campath1 mL in 1 VIAL, SINGLE-USEINJECTION121
58468-0357-3Campath3 in 1 CARTONINJECTION321

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58468-0357CAMPATH (ALEMTUZUMAB) INJECTION [GENZYME CORPORATION]20Current NDC, Legacy NDC, 4 package rows20241213_4f5f7255-7abc-4328-bd1a-ceaf139ef3e0.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58468-0357-1ML - Milliliter58468-0357b2a94b16-4b9d-43ea-8128-2680117eda2612012-07-24
58468-0357-3ML - Milliliter58468-035736e3cd9d-b0a3-4d54-9f2b-be56352cb78012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALEMTUZUMABACTIVE INGREDIENT3A189DH42VCAMPATH (ALEMTUZUMAB) INJECTION [GENZYME CORPORATION]6
ALEMTUZUMABACTIVE MOIETY3A189DH42VCAMPATH (ALEMTUZUMAB) INJECTION [GENZYME CORPORATION]6
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KCAMPATH (ALEMTUZUMAB) INJECTION [GENZYME CORPORATION]6
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCAMPATH (ALEMTUZUMAB) INJECTION [GENZYME CORPORATION]6
POTASSIUM CHLORIDEINACTIVE INGREDIENT660YQ98I10CAMPATH (ALEMTUZUMAB) INJECTION [GENZYME CORPORATION]6
POTASSIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT4J9FJ0HL51CAMPATH (ALEMTUZUMAB) INJECTION [GENZYME CORPORATION]6
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XCAMPATH (ALEMTUZUMAB) INJECTION [GENZYME CORPORATION]6
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74CAMPATH (ALEMTUZUMAB) INJECTION [GENZYME CORPORATION]6

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 10 of 64 · 1,268 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Grain and WheatADRENALINUM, AVENA SATIVA, BRYONIA (ALBA), GLYCINE MAX (SOY), HISTAMINUM HYDROCHLORICUM, BARLEY, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PULSATILLA (PRATENSIS), RYE, WHEAT, CORNNaturalCare3bd8e473-9aac-4a0c-9117-1f1488a75b7b2026-03-03WarningsExact identifier
unii: 451W47IQ8X
Potassium ChloridePOTASSIUM CHLORIDEAmneal Pharmaceuticals of New York LLCcd56e147-92d6-46ce-ae00-63fac08d49b52026-03-03Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Thyroid SupportCALCAREA CARBONICA, CALCAREA IODATA, CAUSTICUM, FERRUM IODATUM, FUCUS VESICULOSUS, KALI IODATUM, NATRUM MURIATICUM, THYROIDINUM (BOVINE)NaturalCare75648609-288c-4988-8b96-46f52d639bd32026-03-03WarningsExact identifier
unii: 451W47IQ8X
Allergy Relief Indoor and OutdoorALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARUM TRIPHYLLUM, ARUNDO MAURITANICA, EUPHRASIA OFFICINALIS, GALPHIMIA GLAUCA, HISTAMINUM HYDROCHLORICUM, KALI BICHROMICUM, NAPHTHALINUM, NATRUM MURIATICUM, SABADILLA, SOLIDAGO VIRGAUREA, STICTA PULMONARIA, SULPHUR, TRIFOLIUM PRATENSE, AND WYETHIA HELENIOIDES.King Bio Inc.9faa963e-4ddc-461f-95a1-2d10e12606122026-03-02WarningsExact identifier
unii: 451W47IQ8X
Refresh Optive Mega-3 PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.326cb5d6-c784-404f-9a13-6d69262dda6e2026-03-01WarningsExact identifier
unii: 6OZP39ZG8H
LibidotoneARALIA QUINQUEFOLIA, BERBERIS VULGARIS, AGNUS CASTUS, AVENA SATIVA, CAUSTICUM, CONIUM MACULATUM, DAMIANA, GRAPHITES, HYPOPHYSIS SUIS, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SELENIUM METALLICUM, SEPIAEnergique, Inc.4ceacaa0-0219-421a-8fff-c1784c3d0f702026-02-27WarningsExact identifier
unii: 451W47IQ8X
911 Adrenal Burnout and FatigueACETICUM AC, ADRENALINUM, ADRENOCORTICOTROPHIN (30X), AESCULUS HIPPOCASTANUM, FLOS, ALFALFA, ALPHA-LIPOIC AC, AMBRA, ARG NIT, AVENA SATIVA, BRYONIA, CARBONEUM OXYGENISATUM, CARPINUS BETULUS, FLOS, DNA, FUMARICUM ACIDUM, GELSEMIUM SEMPERVIRENS, HEPAR SULPHURIS CALCAREUM, HYPOTHALAMUS, KALI PHOSPHORICUM, LACTICUM ACIDUM, LECITHIN, NATRUM MURIATICUM, OXALICUM ACIDUM, PHOSPHORICUM ACIDUM, PITUITARUM POSTERIUM, SARCOLACTICUM ACIDUM, SELENIUM METALLICUM, SEPIA, SILICEA, SUCCINICUM ACIDUM AND THYROIDINUM.King Bio Inc.21c6b6c1-e846-4f25-a1dc-02e79d1be7562026-02-26WarningsExact identifier
unii: 451W47IQ8X
Oimmal Gentle Eye WashSODIUM CHLORIDEShenzhen Shandian Jingling Technology Co., Ltd.4bb4e59b-a43e-fa38-e063-6294a90aea712026-02-26WarningsExact identifier
unii: 451W47IQ8X
sodium chlorideSODIUM CHLORIDEMedefil, Inc.d1468c0f-dd4f-4d38-a84c-c1d1103039652026-02-26Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
ResentmentADRENALINUM, AMMONIUM MURIATICUM, APOCYNUM CANNABINUM, BUTHUS AUSTRALIS, CARDUUS MARIANUS, CINCHONA OFFICINALIS, FEL TAURI, HEPAR SUIS, HEPAR SULPHURIS CALCAREUM, HYPOTHALAMUS SUIS, MANGANUM CARBONICUM, MOSCHUS, NAJA TRIPUDIANS, NATRUM MURIATICUM, NITRICUM ACIDUM, NUX VOMICA, RHUS TOX, TARAXACUM OFFICINALEDeseret Biologicals, Inc.f42e08d9-349e-4e53-802c-175cf17f3f2c2026-02-26WarningsExact identifier
unii: 451W47IQ8X
Anti-Itch Extra StrengthCALENDULA OFFICINALIS FLOWERING TOP, HYPERICUM PERFORATUM WHOLE, AND SODIUM CHLORIDEForces of Nature6131d921-c772-4684-b9ea-c5c8923daaf02026-02-25WarningsExact identifier
unii: 451W47IQ8X
BM BIO28 (General Tonic)CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEABM Private Limited38d2cff0-3550-b119-e063-6394a90a31cb2026-02-23WarningsExact identifier
unii: 451W47IQ8X
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDEA-S Medication Solutions2d67fc67-c99f-4df2-a1e7-4d369cce12c22026-02-23Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Allergy KidsURTICA DIOICA LEAF, INULA HELENIUM ROOT, ANGELICA ARCHANGELICA ROOT, PINE NEEDLE OIL (PINUS SYLVESTRIS), SODIUM CHLORIDE, AND ALTHAEA OFFICINALIS ROOTForces of Nature4886109c-dd7d-40c0-911f-5f12343d8e632026-02-20WarningsExact identifier
unii: 451W47IQ8X
Allergy Maximum StrengthURTICA DIOICA, ALTHAEA OFFICINALIS ROOT, INULA HELENIUM ROOT, ANGELICA ARCHANGELICA ROOT, PINE NEEDLE OIL (PINUS SYLVESTRIS), SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature122ca23e-43f1-4e5c-afc2-1418b17176792026-02-20WarningsExact identifier
unii: 451W47IQ8X
Back Pain Pain ManagementARNICA MONTANA, HORSE CHESTNUT, HYPERICUM PERFORATUM, RUTA GRAVEOLENS WHOLE, AND SODIUM CHLORIDEForces of Naturebf089347-f334-4d6d-ab58-cf7f0b16810f2026-02-20WarningsExact identifier
unii: 451W47IQ8X
CVS PharmacySALINE LAXATIVECVS Pharmacyedd58c52-18de-4ec4-aec3-44f3e17607a72026-02-17WarningsExact identifier
unii: GR686LBA74
RHODODIUMACTEA RACEMOSA, APIS MELL, CALC CARB, GRAPHITES, IODIUM, NATRUM MUR, PULSATILLA, RHODODENDRONBM Private Limited3b3bcba2-6f9e-cd94-e063-6394a90a77012026-02-15WarningsExact identifier
unii: 451W47IQ8X
FuligoCIMICIFUGA, DROSERA, FORMICA RUFA, FULIGO, INULA HEL., KALI MUR, LAPIS ALBUS, SILICEABM Private Limited3b27225f-4587-d915-e063-6294a90a72252026-02-12WarningsExact identifier
unii: 660YQ98I10
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEMajor Pharmaceuticals33ad1eb2-1f05-461c-b01d-82dee42315562026-02-11Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10

Reported adverse events (FAERS/openFDA)#

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