lemtrada

Generic: alemtuzumab

Labeler: genzyme corporation
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name lemtrada
Generic Name alemtuzumab
Labeler genzyme corporation
Dosage Form INJECTION, SOLUTION, CONCENTRATE
Routes
INTRAVENOUS
Active Ingredients

alemtuzumab 12 mg/1.2mL

Manufacturer
Genzyme Corporation

Identifiers & Regulatory

Product NDC 58468-0200
Product ID 58468-0200_e9b870b2-1ea2-433f-991a-721c3cf582b1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA103948
Listing Expiration 2026-12-31
Marketing Start 2014-11-18

Pharmacologic Class

Established (EPC)
cd52-directed cytolytic antibody [epc]
Mechanism of Action
cd52-directed antibody interactions [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 584680200
Hyphenated Format 58468-0200

Supplemental Identifiers

RxCUI
1594658 1594663
UNII
3A189DH42V
NUI
N0000175079 N0000175659

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name lemtrada (source: ndc)
Generic Name alemtuzumab (source: ndc)
Application Number BLA103948 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 12 mg/1.2mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-USE in 1 CARTON (58468-0200-1) / 1.2 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (1)

58468-0200-1 1 VIAL, SINGLE-USE in 1 CARTON (58468-0200-1) / 1.2 mL in 1 VIAL, SINGLE-USE

Ingredients (1)

alemtuzumab (12 mg/1.2mL)

Linked Drug Pages (1)

LEMTRADA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "e9b870b2-1ea2-433f-991a-721c3cf582b1", "openfda": {"nui": ["N0000175079", "N0000175659"], "unii": ["3A189DH42V"], "rxcui": ["1594658", "1594663"], "spl_set_id": ["6236b0bc-82e9-4447-9a78-f57d94770269"], "pharm_class_epc": ["CD52-directed Cytolytic Antibody [EPC]"], "pharm_class_moa": ["CD52-directed Antibody Interactions [MoA]"], "manufacturer_name": ["Genzyme Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-USE in 1 CARTON (58468-0200-1)  / 1.2 mL in 1 VIAL, SINGLE-USE", "package_ndc": "58468-0200-1", "marketing_start_date": "20141118"}], "brand_name": "LEMTRADA", "product_id": "58468-0200_e9b870b2-1ea2-433f-991a-721c3cf582b1", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "pharm_class": ["CD52-directed Antibody Interactions [MoA]", "CD52-directed Cytolytic Antibody [EPC]"], "product_ndc": "58468-0200", "generic_name": "ALEMTUZUMAB", "labeler_name": "Genzyme Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LEMTRADA", "active_ingredients": [{"name": "ALEMTUZUMAB", "strength": "12 mg/1.2mL"}], "application_number": "BLA103948", "marketing_category": "BLA", "marketing_start_date": "20141118", "listing_expiration_date": "20261231"}