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 52 of 64 · 1,268 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Potassium ChloridePOTASSIUM CHLORIDENexus Pharamaceuticals Inc.765ef38c-df36-46d1-9062-61e30ff46a862023-06-13Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Endopar FCIMICIFUGA RACEMOSA, FUCUS VESICULOSUS, OOPHORINUM (SUIS), HYPOPHYSIS SUIS, THYROIDINUM (SUIS), GRAPHITES, LACHESIS MUTUS, NATRUM MURIATICUM, PULSATILLA (PRATENSIS), SEPIAEnergique, Inc.d186ae0e-0dc3-48e7-9e22-6778bb80ad182023-06-07WarningsExact identifier
unii: 451W47IQ8X
LY-COANGELICA ARCHANGELICA, KALI MURIATICUM, YUCCA FILAMENTOSA, CARTILAGO SUIS, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, RHUS TOX, CAUSTICUM, MAGNESIA PHOSPHORICA, MANGANUM METALLICUM, OXALICUM ACIDUM, ARNICA MONTANA, BORRELIA BURGDORFERI NOSODE, LATRODECTUS MACTANS, CITRICUM ACIDUM, CYTOMEGALOVIRUS NOSODE, RICKETTSIA NOSODE (RICKETTSIA PROWAZEKII), CHLAMYDIA TRACHOMATIS, LEDUM PALUSTREBhp Holdings, Inc.47140966-5b49-432d-bf35-bcae14f420822023-06-01WarningsExact identifier
unii: 660YQ98I10
Lyme and Co-Infection NosodeANGELICA ARCHANGELICA, KALI MURIATICUM, YUCCA FILAMENTOSA, CARTILAGO SUIS, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, RHUS TOX, CAUSTICUM, MAGNESIA PHOSPHORICA, MANGANUM METALLICUM, OXALICUM ACIDUM, ARNICA MONTANA, BABESIA MICROTI, BORRELIA BURGDORFERI NOSODE, LATRODECTUS MACTANS, CITRICUM ACIDUM, CYTOMEGALOVIRUS NOSODE, RICKETTSIA NOSODE (RICKETTSIA PROWAZEKII), CHLAMYDIA TRACHOMATIS, LEDUM PALUSTREBhp Holdings, Inc.f6186157-256f-4454-b122-f7665e3286f42023-06-01WarningsExact identifier
unii: 660YQ98I10
Cyclease PMSESTRONE, SODIUM CHLORIDE, SEPIA OFFICINALIS JUICELaboratoires Boiron09ff0633-2992-4aba-96ed-45a69f3ee5892023-05-30WarningsExact identifier
unii: 451W47IQ8X
BACTERIOSTATIC SODIUM CHLORIDESODIUM CHLORIDEMedical Purchasing Solutions, LLC8a0d24a9-d02a-0379-e053-2a95a90af7122023-05-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Histastat PollenBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), ADRENALINUM, ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, NATRUM MURIATICUM, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS, PULSATILLA (PRATENSIS), SABADILLA, SINAPIS NIGRA, SOLIDAGO VIRGAUREA, SULPHUR, WYETHIA HELENIOIDESEnergique, Inc.00478787-ccec-4101-a0da-fd337037c3ee2023-05-12WarningsExact identifier
unii: 451W47IQ8X
Natrum MuriaticumNATRIUM MURIATICUMTrue Botanica, LLC7d2d9129-8683-484d-e053-2a91aa0a6f8f2023-05-01WarningsExact identifier
unii: 451W47IQ8X
CosmestatALFALFA, AVENA SATIVA, IODIUM, BOVISTA, FORMALINUM, HYPOPHYSIS SUIS, MANGANUM ACETICUM, NATRUM MURIATICUM, PETROLEUM, PULSATILLA (PRATENSIS), RHUS TOX, TEREBINTHINA, THYROIDINUM (BOVINE), CORTISONE ACETICUMEnergique, Inc.edc8eb65-84b3-433f-8aad-7a741f5637182023-04-17WarningsExact identifier
unii: 451W47IQ8X
Baby Nighttime Mucus Plus Cold ReliefCALCIUM SULFIDE,PHOSPHORUS,SULFUR,RUMEX CRISPUS ROOT,SODIUM CHLORIDE,ARABICA COFFEE BEAN,ANEMONE PULSATILLA,SILICON DIOXIDE, GOLDENSEAL,ONION,BRYONIA ALBA ROOT,EUPHRASIA STRICTA AND MATRICARIA CHAMOMILLAHyland's Inc.736b2487-e81d-d172-e053-2a91aa0ab0cf2023-04-17WarningsExact identifier
unii: 451W47IQ8X
RadialginCITRUS LIMONUM, FUCUS VESICULOSUS, HYDRANGEA ARBORESCENS, SODIUM ALGINATE, NATRUM MURIATICUM, PHOSPHORUS, AGATE, RADIUM BROMATUM, X RAYNutritional Specialties, Inc.f1414ae2-4068-4076-bf11-b57a34ba5df22023-04-12WarningsExact identifier
unii: 451W47IQ8X
GlutenstatALFALFA, ZINGIBER OFFICINALE, CINCHONA OFFICINALIS, HYDRASTIS CANADENSIS, BARLEY (GRAIN), CARBO VEGETABILIS, GLYPHOSATE, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, OAT (GRAIN), PULSATILLA (VULGARIS), RYE (GRAIN), WHEAT (GRAIN), GLUTENEnergique, Inc.c6b867b6-74d9-4725-90d7-7d5d1fe611212023-04-05WarningsExact identifier
unii: 451W47IQ8X
AnxietyBORAX, NATRUM MURIATICUM, CAUSTICUM, ELETTARIA CARDAMOMUM, PLUMBUM METALLICUM, SEPIA, LILIUM TIGRINUM, OXYTROPIS LAMBERTIINutritional Specialties, Inc.657ed32f-3ac7-4806-96b4-4c7aa0f65e7f2023-04-03WarningsExact identifier
unii: 451W47IQ8X
Virility LiquescenceAVENA SATIVA, DAMIANA, BERBERIS VULGARIS, EPIMEDIUM GRANDIFLORUM, GLYCERINUM, SABAL SERRULATA, IODIUM, LECITHIN, FERRUM MURIATICUM, NATRUM MURIATICUM, AGNUS CASTUS, BUFO RANA, CINCHONA OFFICINALIS, HUMAN GROWTH HORMONE (HGH), ORCHITINUM (BOVINE), PHOSPHORICUM ACIDUM, PHOSPHORUS, SELENIUM METALLICUM, ZINCUM VALERIANICUM, OOPHORINUM (SUIS), SEPIANutritional Specialties, Inc.81cc3e2b-f95e-4ba4-a15f-c07b4def0e2f2023-03-29WarningsExact identifier
unii: 451W47IQ8X
Spleen Thymus LiquescenceCINCHONA OFFICINALIS, QUERCUS GLANDIUM SPIRITUS, CEANOTHUS AMERICANUS, SPLEEN (BOVINE), THYMUS (BOVINE), CHININUM ARSENICOSUM, NATRUM MURIATICUM, HELIANTHUS ANNUUSNutritional Specialties, Inc.bc1cc31e-0e8a-49a2-9654-f00eaa72fc042023-03-24WarningsExact identifier
unii: 451W47IQ8X
Myco Immuno NosodeDU HUO (ANGELICA PUBESCENS), ANGELICA ARCHANGELICA, KALI MURIATICUM, RADIX SILERIS (SAPOSHNIKOVIA DIVARICATA), YUCCA FILAMENTOSA, ACHYRANTHES BIDENTATA, ANGELICA SINENSIS, LIGUSTICUM PORTERI, PANAX GINSENG, RHUS TOX, HYDRASTIS CANADENSIS, UNCARIA TOMENTOSA, CARTILAGO SUIS, HORDEUM VULGARE, OXALICUM ACIDUM, ARNICA MONTANA, LATRODECTUS MACTANS, MAGNESIA PHOSPHORICA, MANGANUM METALLICUM, BORRELIA BURGDORFERI, BABESIA MICROTINutritional Specialties, Inc.34dc93af-0c39-4e06-a8d6-9e1ccc77aa232023-03-17WarningsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDEFresenius Kabi USA, LLCfcd4f458-ce27-417e-9bb6-de1cc49d44b92023-02-27Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
K-Phos No. 2POTASSIUM PHOSPHATE, MONOBASIC AND SODIUM PHOSPHATE, MONOBASIC, ANHYDROUSBeach Products, Inc.9f446400-c403-4971-879e-1341f7f7d9da2023-02-23Adverse reactionsExact identifier
unii: 4J9FJ0HL51
K Phos OriginalPOTASSIUM PHOSPHATE, MONOBASICBeach Products, Inc.04557ab3-6d21-49b4-b849-744c75b8a6302023-02-23Adverse reactionsExact identifier
unii: 4J9FJ0HL51
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: 4J9FJ0HL51

Reported adverse events (FAERS/openFDA)#

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