NDC 58468-0357

Campath

Alemtuzumab

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

• Product ID: 58468-0357_0963a067-a84f-436f-84e5-885a4615dde7
• NDC: 58468-0357
• Product Type: Human Prescription Drug
• Proprietary Name: Campath
• Generic Name: Alemtuzumab
• Dosage Form: Injection
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2009-11-30
• Marketing Category: BLA / BLA
• Application Number: BLA103948
• Labeler Name: Genzyme Corporation
• Substance Name: ALEMTUZUMAB
• Active Ingredient Strength: 30 mg/mL
• Pharm Classes: CD52-directed Antibody Interactions [MoA],CD52-directed Cytolytic Antibody [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 58468-0357-1

1 VIAL, SINGLE-USE in 1 CARTON (58468-0357-1) > 1 mL in 1 VIAL, SINGLE-USE

• Marketing Start Date: 2009-11-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 58468-0357-1 [58468035701]

Campath INJECTION

• Marketing Category: BLA
• Application Number: BLA103948
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2009-11-30

NDC 58468-0357-3 [58468035703]

Campath INJECTION

• Marketing Category: BLA
• Application Number: BLA103948
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2009-11-30

Drug Details

Active Ingredients

Ingredient	Strength
ALEMTUZUMAB	30 mg/mL

OpenFDA Data

• SPL SET ID: 4f5f7255-7abc-4328-bd1a-ceaf139ef3e0
• Manufacturer:
  • Genzyme Corporation
• UNII:
  • 3A189DH42V
• RxNorm Concept Unique ID - RxCUI:
  • 828265
  • 828267

Pharmacological Class

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

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

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