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 20 of 64 · 1,268 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GURUNANDA NASAL SALINENASAL WASHGURUNANDA LLC27dbf0bf-c273-2108-e063-6394a90a0a092025-11-10WarningsExact identifier
unii: 451W47IQ8X
LUMOe SKIN1 Skin RemedyKALI MURIATICUM, PRUNUS SPINOSA, SILICEA, SARSAPARILLAApplied Bioenergetics, LLCd4d7fd2f-66bf-407d-ad36-2462e880b9f52025-11-10WarningsExact identifier
unii: 660YQ98I10
LUMO Heal Seasonal Flu CompanionARSENICUM ALBUM, EUPATORIUM PERFOLIATUM, KALI MURIATICUM, STICTA PULMONARIAApplied Bioenergetics, LLCda6b6258-f91e-4283-aeb2-54e7885a80b82025-11-10WarningsExact identifier
unii: 660YQ98I10
AZO Yeast PlusCANDIDA ALBICANS, WOOD CREOSOTE, SODIUM CHLORIDE, AND SULFURi-Health, Inc.22845cac-8011-4ea8-b35e-b72973eddb442025-11-07WarningsExact identifier
unii: 451W47IQ8X
SODIUM CHLORIDESODIUM CHLORIDEHenry Schein, Inc.2e81ffca-05c6-4fa0-8911-4b3cbfa713512025-11-07Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDERising Pharma Holdings, Inc.42870188-b1d7-4934-a6c0-310530497dac2025-11-07WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEHenry Schein, Inc.d8b8d796-bfba-42af-a859-99d7768715582025-11-07Adverse reactionsExact identifier
unii: 451W47IQ8X
Bacteriostatic Sodium ChlorideSODIUM CHLORIDEHenry Schein, Inc.31188cdf-7bc8-4d78-bfaf-c1dc9f851fd42025-11-07Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Potassium ChloridePOTASSIUM CHLORIDEHenry Schein, Inc.8367a2ae-dfd9-4515-838c-529920291ca02025-11-07Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEBryant Ranch Prepack2feda15e-f325-41fe-a442-41a8cc62b8552025-11-06Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEA-S Medication Solutionsd486f982-a7d3-463d-a68d-89365ddaf5bb2025-11-06Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium chloridePOTASSIUM CHLORIDEA-S Medication Solutions4a2173ba-556b-4ad7-be81-4da79b7394902025-11-06Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium Chloride Extended-releasePOTASSIUM CHLORIDE EXTENDED-RELEASEA-S Medication Solutionsde335131-bb8a-44e5-89fa-1478edbcdc0e2025-11-06Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEBryant Ranch Prepack6fc9eef0-3dfc-4344-85c7-9f11d9b99b652025-11-06Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium Chloride Extended-releasePOTASSIUM CHLORIDE EXTENDED-RELEASEA-S Medication Solutionsedb6c987-e2c3-421f-8a8d-849c9e17ace82025-11-06Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Potassium Chloride Extended-ReleasePOTASSIUM CHLORIDEBryant Ranch Prepack1b64b0c9-31a2-4ee7-8818-66de906ebeda2025-11-06Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10
Lactated RingersSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEB. Braun Medical Inc.d3d29c8f-c326-4097-814a-7f4e08c670682025-11-05Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
unii: 660YQ98I10
RingersSODIUM CHLORIDE, CALCIUM CHLORIDE, AND POTASSIUM CHLORIDEB. Braun Medical Inc.01721071-af03-4894-95c1-10b8bc64b8882025-11-05Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
unii: 660YQ98I10
Dextrose in Lactated RingersDEXTROSE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEB. Braun Medical Inc.190da07e-a616-46e6-b4e5-1c0ba39306e52025-11-05Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
unii: 660YQ98I10
Potassium ChloridePOTASSIUM CHLORIDEA-S Medication Solutions0ac9b8dc-0c8e-4cdc-ab9d-bd8cab4f49582025-11-05Warnings, Adverse reactionsExact identifier
unii: 660YQ98I10

Reported adverse events (FAERS/openFDA)#

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