NDC Code(s) : 62856-250-01, 62856-250-10, 62856-500-01, 62856-500-10, 62856-750-01, 62856-750-10, 62856-100-01, 62856-100-10, 62856-101-01, 62856-101-10, 62856-125-01, 62856-125-10, 62856-150-01, 62856-150-10, 62856-180-01, 62856-180-10, 62856-251-01, 62856-102-01
Packager : Eisai Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Fragmindalteparin 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 SODIUM2500 [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
1NDC:62856-250-1010 in 1 CARTON
1NDC:62856-250-010.2 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
Fragmindalteparin 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 SODIUM5000 [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
1NDC:62856-500-1010 in 1 CARTON
1NDC:62856-500-010.2 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
Fragmindalteparin 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 SODIUM7500 [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
1NDC:62856-750-1010 in 1 CARTON
1NDC:62856-750-010.3 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
Fragmindalteparin 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
Ingredient Name Basis of Strength Strength
DALTEPARIN SODIUM(UNII: 12M44VTJ7B)
(DALTEPARIN - UNII:S79O08V79F) 		DALTEPARIN SODIUM10000 [iU] in 0.4 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:62856-100-1010 in 1 CARTON
1NDC:62856-100-010.4 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
Fragmindalteparin sodium INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62856-101
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DALTEPARIN SODIUM(UNII: 12M44VTJ7B)
(DALTEPARIN - UNII:S79O08V79F) 		DALTEPARIN SODIUM10000 [iU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:62856-101-1010 in 1 CARTON
1NDC:62856-101-011 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
Fragmindalteparin sodium INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62856-125
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DALTEPARIN SODIUM(UNII: 12M44VTJ7B)
(DALTEPARIN - UNII:S79O08V79F) 		DALTEPARIN SODIUM12500 [iU] in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:62856-125-1010 in 1 CARTON
1NDC:62856-125-010.5 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
Fragmindalteparin sodium INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62856-150
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DALTEPARIN SODIUM(UNII: 12M44VTJ7B)
(DALTEPARIN - UNII:S79O08V79F) 		DALTEPARIN SODIUM15000 [iU] in 0.6 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:62856-150-1010 in 1 CARTON
1NDC:62856-150-010.6 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
Fragmindalteparin 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 SODIUM18000 [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
1NDC:62856-180-1010 in 1 CARTON
1NDC:62856-180-010.72 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
Fragmindalteparin 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 SODIUM25000 [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
1NDC:62856-251-011 in 1 CARTON
13.8 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
Fragmindalteparin 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 SODIUM10000 [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
1NDC:62856-102-011 in 1 CARTON
19.5 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

PRINCIPAL DISPLAY PANEL

NDC 62856-250-10 (Single-dose prefilled syringes)

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PRINCIPAL DISPLAY PANEL

NDC 62856-500-10 (Single-dose prefilled syringes)

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PRINCIPAL DISPLAY PANEL

NDC 62856-750-10 (Single-dose prefilled syringes)

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PRINCIPAL DISPLAY PANEL

NDC 62856-100-10 (Single-dose prefilled syringes)

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PRINCIPAL DISPLAY PANEL

NDC 62856-101-10 (Single-dose graduated syringes)

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PRINCIPAL DISPLAY PANEL

NDC 62856-125-10 (Single-dose prefilled syringes)

fragmin-08

PRINCIPAL DISPLAY PANEL

NDC 62856-150-10 (Single-dose prefilled syringes)

fragmin-09

PRINCIPAL DISPLAY PANEL

NDC 62856-180-10 (Single-dose prefilled syringes)

fragmin-10

PRINCIPAL DISPLAY PANEL

NDC 62856-251-01 (Multiple dose vial)

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PRINCIPAL DISPLAY PANEL

NDC 62856-102-01 (Multiple dose vial)

fragmin-12