Home NDC 58468-0200 LEMTRADA
Product NDC 58468-0200
11-digit product format 584680200
Labeler code 58468
Product ID 58468-0200_e9b870b2-1ea2-433f-991a-721c3cf582b1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ALEMTUZUMAB
Dosage form INJECTION, SOLUTION, CONCENTRATE
Route INTRAVENOUS
Labeler Genzyme Corporation
Application BLA103948
Marketing category BLA
Marketing start 2014-11-18
Substance ALEMTUZUMAB
Active strength 12 mg/1.2mL
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 LEMTRADA
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ALEMTUZUMAB 12 mg/1.2mL
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 1594658 Internal RxNorm lookup 1594663 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 58468-0200-1 LEMTRADA 1 in 1 CARTON INJECTION, SOLUTION, CONCENTRATE 1 26 58468-0200-1 LEMTRADA 1.2 mL in 1 VIAL, SINGLE-USE INJECTION, SOLUTION, CONCENTRATE 1.2 26
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ALEMTUZUMAB ACTIVE INGREDIENT 3A189DH42V LEMTRADA (ALEMTUZUMAB) INJECTION, SOLUTION, CONCENTRATE [GENZYME CORPORATION] 1 alemtuzumab ACTIVE MOIETY 3A189DH42V LEMTRADA (ALEMTUZUMAB) INJECTION, SOLUTION, CONCENTRATE [GENZYME CORPORATION] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K LEMTRADA (ALEMTUZUMAB) INJECTION, SOLUTION, CONCENTRATE [GENZYME CORPORATION] 1 Polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H LEMTRADA (ALEMTUZUMAB) INJECTION, SOLUTION, CONCENTRATE [GENZYME CORPORATION] 1 POTASSIUM CHLORIDE INACTIVE INGREDIENT 660YQ98I10 LEMTRADA (ALEMTUZUMAB) INJECTION, SOLUTION, CONCENTRATE [GENZYME CORPORATION] 1 POTASSIUM PHOSPHATE, MONOBASIC INACTIVE INGREDIENT 4J9FJ0HL51 LEMTRADA (ALEMTUZUMAB) INJECTION, SOLUTION, CONCENTRATE [GENZYME CORPORATION] 1 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X LEMTRADA (ALEMTUZUMAB) INJECTION, SOLUTION, CONCENTRATE [GENZYME CORPORATION] 1 SODIUM PHOSPHATE, DIBASIC INACTIVE INGREDIENT GR686LBA74 LEMTRADA (ALEMTUZUMAB) INJECTION, SOLUTION, CONCENTRATE [GENZYME CORPORATION] 1 Water INACTIVE INGREDIENT 059QF0KO0R LEMTRADA (ALEMTUZUMAB) INJECTION, SOLUTION, CONCENTRATE [GENZYME CORPORATION] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58468-0200 LEMTRADA (ALEMTUZUMAB) INJECTION, SOLUTION, CONCENTRATE [GENZYME CORPORATION] 25 Current NDC, Legacy NDC, 2 package rows 20240522_6236b0bc-82e9-4447-9a78-f57d94770269.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 58468-0200-1 58468020001 1 VIAL, SINGLE-USE in 1 CARTON (58468-0200-1) / 1.2 mL in 1 VIAL, SINGLE-USE 2014-11-18 0000-00-00 No No Current