NDC 58468-0200

LEMTRADA

Alemtuzumab

LEMTRADA is a Intravenous Injection, Solution, Concentrate in the Human Prescription Drug category. It is labeled and distributed by Genzyme Corporation. The primary component is Alemtuzumab.

• Product ID: 58468-0200_0651f1b8-87ac-45fa-bafb-755ddbfb78cf
• NDC: 58468-0200
• Product Type: Human Prescription Drug
• Proprietary Name: LEMTRADA
• Generic Name: Alemtuzumab
• Dosage Form: Injection, Solution, Concentrate
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2014-11-18
• Marketing Category: BLA / BLA
• Application Number: BLA103948
• Labeler Name: Genzyme Corporation
• Substance Name: ALEMTUZUMAB
• Active Ingredient Strength: 12 mg/1.2mL
• Pharm Classes: CD52-directed Antibody Interactions [MoA], CD52-directed Cytolytic Antibody [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 58468-0200-1

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

• Marketing Start Date: 2014-11-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 58468-0200-1 [58468020001]

LEMTRADA INJECTION, SOLUTION, CONCENTRATE

• Marketing Category: BLA
• Application Number: BLA103948
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2014-11-18

Drug Details

Active Ingredients

Ingredient	Strength
ALEMTUZUMAB	12 mg/1.2mL

OpenFDA Data

• SPL SET ID: 6236b0bc-82e9-4447-9a78-f57d94770269
• Manufacturer:
  • Genzyme Corporation
• UNII:
  • 3A189DH42V
• RxNorm Concept Unique ID - RxCUI:
  • 1594663
  • 1594658
• UPC Code:
  • 0358468020017

Pharmacological Class

• CD52-directed Antibody Interactions [MoA]
• CD52-directed Cytolytic Antibody [EPC]

Medicade Reported Pricing

58468002001 RENAGEL 400 MG TABLET

Pricing Unit: EA | Drug Type:

NDC Crossover Matching brand name "LEMTRADA" or generic name "Alemtuzumab"

NDC	Brand Name	Generic Name
58468-0200	LEMTRADA	ALEMTUZUMAB
58468-0357	Campath	ALEMTUZUMAB