NDC 62856-102-01 (Multiple dose vial)

INGREDIENTS AND APPEARANCE
FRAGMIN 
dalteparin sodium injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62856-250
Route of Administration SUBCUTANEOUS DEA Schedule     
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DALTEPARIN SODIUM (UNII: 12M44VTJ7B) (DALTEPARIN - UNII:S79O08V79F) DALTEPARIN SODIUM 2500 [iU]  in 0.2 mL
 
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
 
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:62856-250-10 10 in 1 CARTON  
1 NDC:62856-250-01 0.2 mL in 1 SYRINGE; Type 0: Not a Combination Product  

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020287 12/22/1994 
 
FRAGMIN 
dalteparin sodium injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62856-500
Route of Administration SUBCUTANEOUS DEA Schedule     
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DALTEPARIN SODIUM (UNII: 12M44VTJ7B) (DALTEPARIN - UNII:S79O08V79F) DALTEPARIN SODIUM 5000 [iU]  in 0.2 mL
 
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
 
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:62856-500-10 10 in 1 CARTON  
1 NDC:62856-500-01 0.2 mL in 1 SYRINGE; Type 0: Not a Combination Product  
 
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020287 12/22/1994 
 
FRAGMIN 
dalteparin sodium injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62856-750
Route of Administration SUBCUTANEOUS DEA Schedule     
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DALTEPARIN SODIUM (UNII: 12M44VTJ7B) (DALTEPARIN - UNII:S79O08V79F) DALTEPARIN SODIUM 7500 [iU]  in 0.3 mL
 
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
 
 
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:62856-750-10 10 in 1 CARTON  
1 NDC:62856-750-01 0.3 mL in 1 SYRINGE; Type 0: Not a Combination Product  
 
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020287 12/22/1994 
 
FRAGMIN 
dalteparin sodium injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62856-100
Route of Administration SUBCUTANEOUS DEA Schedule     
 
Active Ingredient/Active Moiety