FDA.reportPublic FDA data

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 14 of 64 · 1,268 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RET Lung 7003RET LUNGProfessional Complementary Health Formulas2ed03832-f226-4b3c-9ee6-5352f8d79fdb2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Melancholy Drops Introvert 2016MELANCHOLY DROPS INTROVERTProfessional Complementary Health Formulas60e305b4-bb1f-465e-963d-38e6b38df98d2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Spleen Stim Liquescence 3028SPLEEN STIM LIQUESCENCEProfessional Complementary Health Formulas463b62a5-4d4f-445f-ba24-859195730cab2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Melancholy Drops 2002MELANCHOLY DROPSProfessional Complementary Health Formulas96d7f202-c19b-4914-96bb-9906ad781ad02026-01-08WarningsExact identifier
unii: 451W47IQ8X
Natrum Muriaticum 8009NATRUM MURIATICUMProfessional Complementary Health Formulasb4a48b58-28c0-4368-83e8-40ce52ae5f2b2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Aletris Combination 9203ALETRIS COMBINATIONProfessional Complementary Health Formulas87ae7310-927b-48fe-b659-6f93dad623632026-01-08WarningsExact identifier
unii: 451W47IQ8X
Fertility Drops 2174FERTILITY DROPSProfessional Complementary Health Formulas78985992-bb47-4045-82f3-a6094e48d50a2026-01-08WarningsExact identifier
unii: 451W47IQ8X
RET Liver 7008RET LIVERProfessional Complementary Health Formulasd81bdbbd-5cfa-40e3-99f5-fd5368239fbe2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Herbal Diuretic Liquescence 3011HERBAL DIURETIC LIQUESCENCEProfessional Complementary Health Formulas5eee7f21-a3c4-46e0-a642-a4ca635734e32026-01-08WarningsExact identifier
unii: 451W47IQ8X
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEAdvagen Pharma Limiteda9e9d134-55d0-47ae-925f-de07e7ffa4b82026-01-07Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
POTASSIUM CHLORIDEPOTASSIUM CHLORIDEAdvagen Pharma Ltd.f4497c26-da16-45b0-975d-81f2c21327042026-01-07Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Sodium chlorideSODIUM CHLORIDEBECTON DICKINSON AND COMPANYd39b7307-df67-4e68-acb0-2eda5dc612152026-01-07Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Potassium ChloridePOTASSIUM CHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23b10bd6-11bc-495e-bb05-ec332a9b3f212026-01-06Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium Chloride for Oral SolutionPOTASSIUM CHLORIDE FOR ORAL SOLUTIONBPI Labs LLC1ea4345e-f8bb-4d41-9003-c87b21169d7c2026-01-05Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Lung DrainageANTIMONIUM ARSENICICUM, BRYONIA (ALBA), CAMPHORA, CARBO VEGETABILIS, CHELIDONIUM MAJUS, CHININUM MURIATICUM, CUPRUM METALLICUM, GELSEMIUM SEMPERVIRENS, HAEMOPHILUS INFLUENZAE B, IPECACUANHA, KALI MURIATICUM, LOBELIA PURPURESCENS, LUNG (SUIS), MYCOPLASMA PNEUMONIAE, MYCOPLASMA PNEUMONIAE DNA, OXYGENIUM, PHOSPHORUS, PNEUMOCOCCINUM, SENEGA OFFICINALIS, STANNUM METALLICUM, VERATRUM VIRIDEDeseret Biologicals, Inc.64a99cd3-341a-44ec-b4eb-c06982e6d4142026-01-05WarningsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDENorthwind Health Company, LLCf2b671c9-9874-2668-e053-2a95a90a1b462026-01-01Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDENorthwind Health Company, LLCf3081031-8234-5732-e053-2995a90aebeb2026-01-01Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDENorthwind Health Company, LLCdae7c63d-eef0-58d0-e053-2a95a90a667e2026-01-01Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDENorthwind Health Company, LLCdb4dc4ab-e0d4-7dc7-e053-2995a90ac46e2026-01-01Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
B03 Sinus ReliefALLIUM CEPA, CALCAREA IODATA, CALCAREA SULPHURICA, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, EUPHORBIUM OFFICINARUM, HEPAR SULPHURIS CALCAREUM, HISTAMINUM HYDROCHLORICUM, HYDRASTIS CANADENSIS, KALI BICHROMICUM, KALI MURIATICUM, KALI SULPHURICUM, LAC DEFLORATUM, LUFFA OPERCULATA, MERCURIUS SULPHURATUS RUBER, PHOSPHORUS, PULSATILLA VULGARIS, SACCHARUM LACTIS, THUJA OCCIDENTALISApex Energetics Inc.bad83f77-e9ae-7118-e053-2a95a90aa7372025-12-31WarningsExact identifier
unii: 660YQ98I10

Reported adverse events (FAERS/openFDA)#

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