NDC 50419-357-03
3 Single-Use 1 mL Vials
Campath
Alemtuzumab
For Intravenous Use Only
30 mg/mL
No US Standard of Potency
Must be further diluted prior to IV administration
Single-Use Vial, Discard Unused Portion
See package insert for full prescribing information
Sterile
Rx Only
Note: Concentration change to 30 mg/mL
See revised insert for new instructions for preparation and administration.
30 mg/mL
- 30 mg/mL
- 3 vials
- Injection

CAMPATH 
alemtuzumab   injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 50419-357
Route of Administration INTRAVENOUS DEA Schedule      
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALEMTUZUMAB (ALEMTUZUMAB)  ALEMTUZUMAB 30 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 8 mg  in 1 mL
SODIUM PHOSPHATE, DIBASIC 1.44 mg  in 1 mL
POTASSIUM CHLORIDE 0.2 mg  in 1 mL
POTASSIUM PHOSPHATE, MONOBASIC 0.2 mg  in 1 mL
POLYSORBATE 80 0.1 mg  in 1 mL
EDETATE DISODIUM 0.0187 mg  in 1 mL
Product Characteristics
Color      Score     
Shape  Size 
Flavor  Imprint Code 
Contains     
Packaging
NDC Package Description Multilevel Packaging
1 50419-357-01 1 VIAL In 1 CARTON contains a VIAL, SINGLE-USE
1  1 mL In 1 VIAL, SINGLE-USE This package is contained within the CARTON (50419-357-01)
2 50419-357-03 3 VIAL In 1 CARTON contains a VIAL, SINGLE-USE
2  1 mL In 1 VIAL, SINGLE-USE This package is contained within the CARTON (50419-357-03)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103948 04/20/2009 10/31/2011
Labeler - Bayer HealthCare Pharmaceuticals Inc. (828111489) 
Establishment
Name Address ID/FEI Operations
Boehringer Ingelheim Pharma GmbH & Co. KG  551147440 ANALYSIS, MANUFACTURE
Establishment
Name Address ID/FEI Operations
Bayer Schering Pharma AG  315015982 ANALYSIS, MANUFACTURE
Revised: 03/2009Bayer HealthCare Pharmaceuticals Inc.