Home NDC 58468-0357 Campath
Product NDC 58468-0357
11-digit product format 584680357
Labeler code 58468
Product ID 58468-0357_db03295a-9939-43bb-92c5-768721d27a8b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ALEMTUZUMAB
Dosage form INJECTION
Route INTRAVENOUS
Labeler Genzyme Corporation
Application BLA103948
Marketing category BLA
Marketing start 2009-11-30
Substance ALEMTUZUMAB
Active strength 30 mg/mL
Pharmacologic classes CD52-directed Antibody Interactions [MoA], CD52-directed Cytolytic Antibody [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Campath
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ALEMTUZUMAB 30 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3A189DH42V Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 828265 Internal RxNorm lookup 828267 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58468-0357-1 Campath 1 in 1 CARTON INJECTION 1 21 58468-0357-1 Campath 1 mL in 1 VIAL, SINGLE-USE INJECTION 1 21 58468-0357-3 Campath 1 mL in 1 VIAL, SINGLE-USE INJECTION 1 21 58468-0357-3 Campath 3 in 1 CARTON INJECTION 3 21
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58468-0357 CAMPATH (ALEMTUZUMAB) INJECTION [GENZYME CORPORATION] 20 Current NDC, Legacy NDC, 4 package rows 20241213_4f5f7255-7abc-4328-bd1a-ceaf139ef3e0.zip
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 1 of 1 · 2 matching rows.
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 103948 Campath alemtuzumab 351(a) Disc 2026-07-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 58468-0357-1 58468035701 1 VIAL, SINGLE-USE in 1 CARTON (58468-0357-1) / 1 mL in 1 VIAL, SINGLE-USE 2009-11-30 0000-00-00 No No Current 58468-0357-3 58468035703 3 VIAL, SINGLE-USE in 1 CARTON (58468-0357-3) / 1 mL in 1 VIAL, SINGLE-USE 2009-11-30 0000-00-00 No No Current