bsp;
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:62856-150-10 10 in 1 CARTON
1 NDC:62856-150-01 0.6 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:62856-180
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 18000 [iU] in 0.72 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:62856-180-10 10 in 1 CARTON
1 NDC:62856-180-01 0.72 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:62856-251
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 25000 [iU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)
BENZYL ALCOHOL (UNII: LKG8494WBH)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:62856-251-01 1 in 1 CARTON
1 3.8 mL in 1 VIAL; 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:62856-102
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 10000 [iU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)
BENZYL ALCOHOL (UNII: LKG8494WBH)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:62856-102-01 1 in 1 CARTON
1 9.5 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Ci |
