NDC Code(s) : 62037-839-20, 62037-849-20, 62037-861-20, 62037-862-20, 62037-863-20, 62037-864-20, 62037-866-20
Packager : Actavis Pharma, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Enoxaparin SodiumEnoxaparin Sodium INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62037-839
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ENOXAPARIN SODIUM(UNII: 8NZ41MIK1O)
(ENOXAPARIN - UNII:E47C0NF7LV) 		ENOXAPARIN SODIUM30 mg in 0.3 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:62037-839-2010 in 1 CARTON 27/01/2012
11 in 1 BLISTER PACK
10.3 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
ANDA ANDA076684 01/27/2012 05/31/2018
Enoxaparin SodiumEnoxaparin Sodium INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62037-849
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ENOXAPARIN SODIUM(UNII: 8NZ41MIK1O)
(ENOXAPARIN - UNII:E47C0NF7LV) 		ENOXAPARIN SODIUM40 mg in 0.4 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:62037-849-2010 in 1 CARTON 27/01/2012
11 in 1 BLISTER PACK
10.4 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
ANDA ANDA076684 01/27/2012 06/30/2018
Enoxaparin SodiumEnoxaparin Sodium INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62037-861
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ENOXAPARIN SODIUM(UNII: 8NZ41MIK1O)
(ENOXAPARIN - UNII:E47C0NF7LV) 		ENOXAPARIN SODIUM60 mg in 0.6 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:62037-861-2010 in 1 CARTON 27/01/2012
11 in 1 BLISTER PACK
10.6 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
ANDA ANDA076684 01/27/2012 05/31/2018
Enoxaparin SodiumEnoxaparin Sodium INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62037-862
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ENOXAPARIN SODIUM(UNII: 8NZ41MIK1O)
(ENOXAPARIN - UNII:E47C0NF7LV) 		ENOXAPARIN SODIUM80 mg in 0.8 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:62037-862-2010 in 1 CARTON 27/01/2012
11 in 1 BLISTER PACK
10.8 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
ANDA ANDA076684 01/27/2012 06/30/2018
Enoxaparin SodiumEnoxaparin Sodium INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62037-863
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ENOXAPARIN SODIUM(UNII: 8NZ41MIK1O)
(ENOXAPARIN - UNII:E47C0NF7LV) 		ENOXAPARIN SODIUM100 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:62037-863-2010 in 1 CARTON 13/02/2012
11 in 1 BLISTER PACK
11 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
ANDA ANDA076684 02/13/2012 06/30/2018
Enoxaparin SodiumEnoxaparin Sodium INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62037-864
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ENOXAPARIN SODIUM(UNII: 8NZ41MIK1O)
(ENOXAPARIN - UNII:E47C0NF7LV) 		ENOXAPARIN SODIUM120 mg in 0.8 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:62037-864-2010 in 1 CARTON 13/02/2012
11 in 1 BLISTER PACK
10.8 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
ANDA ANDA076684 02/13/2012 06/30/2018
Enoxaparin SodiumEnoxaparin Sodium INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62037-866
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ENOXAPARIN SODIUM(UNII: 8NZ41MIK1O)
(ENOXAPARIN - UNII:E47C0NF7LV) 		ENOXAPARIN SODIUM150 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:62037-866-2010 in 1 CARTON 13/02/2012
11 in 1 BLISTER PACK
11 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
ANDA ANDA076684 02/13/2012 06/30/2018

PRINCIPAL DISPLAY PANEL

NDC 62037-839-20
ENOXAPARIN SODIUM INJECTION
30 mg/0.3 mL
Rx ONLY
FOR SUBCUTANEOUS INJECTION
10 x 30 mg Single Dose Syringes with
Automatic Safety Device
NDC 62037-839-20 ENOXAPARIN SODIUM INJECTION 30 mg/0.3 mL Rx ONLY FOR SUBCUTANEOUS INJECTION 10 x 30 mg Single Dose Syringes with Automatic Safety Device

PRINCIPAL DISPLAY PANEL

NDC 62037-849-20
ENOXAPARIN SODIUM INJECTION
40 mg/0.4 mL
Rx ONLY
FOR SUBCUTANEOUS INJECTION
10 x 40 mg Single Dose Syringes with
Automatic Safety Device
NDC 62037-849-20 ENOXAPARIN SODIUM INJECTION 40 mg/0.4 mL Rx ONLY FOR SUBCUTANEOUS INJECTION 10 x 40 mg Single Dose Syringes with Automatic Safety Device
 

PRINCIPAL DISPLAY PANEL

NDC 62037-861-20
ENOXAPARIN SODIUM INJECTION
60 mg/0.6 mL
Rx ONLY
FOR SUBCUTANEOUS INJECTION
10 x 60 mg Single Dose Syringes with
Automatic Safety Device
NDC 62037-861-20 ENOXAPARIN SODIUM INJECTION 60 mg/0.6 mL Rx ONLY FOR SUBCUTANEOUS INJECTION 10 x 60 mg Single Dose Syringes with Automatic Safety Device

PRINCIPAL DISPLAY PANEL

NDC 62037-862-20
ENOXAPARIN SODIUM INJECTION
80 mg/0.8 mL
Rx ONLY
FOR SUBCUTANEOUS INJECTION
10 x 80 mg Single Dose Syringes with
Automatic Safety Device
NDC 62037-862-20 ENOXAPARIN SODIUM INJECTION 80 mg/0.8 mL Rx ONLY FOR SUBCUTANEOUS INJECTION 10 x 80 mg Single Dose Syringes with Automatic Safety Device

PRINCIPAL DISPLAY PANEL

NDC 62037-863-20
ENOXAPARIN SODIUM INJECTION
100 mg/ mL
Rx ONLY
1 mL Syringe
FOR SUBCUTANEOUS INJECTION
10 x 100 mg Single Dose Syringes with
Automatic Safety Device
NDC 62037-863-20 ENOXAPARIN SODIUM INJECTION 100 mg/ mL Rx ONLY 1 mL Syringe FOR SUBCUTANEOUS INJECTION 10 x 100 mg Single Dose Syringes with Automatic Safety Device

PRINCIPAL DISPLAY PANEL

NDC 62037-864-20
ENOXAPARIN SODIUM INJECTION
120 mg/0.8 mL
Rx ONLY
FOR SUBCUTANEOUS INJECTION
10 x 120 mg Single Dose Syringes with
Automatic Safety Device
NDC 62037-864-20 ENOXAPARIN SODIUM INJECTION 120 mg/0.8 mL Rx ONLY FOR SUBCUTANEOUS INJECTION 10 x 120 mg Single Dose Syringes with Automatic Safety Device

PRINCIPAL DISPLAY PANEL

NDC 62037-866-20
ENOXAPARIN SODIUM INJECTION
150 mg/ mL
Rx ONLY
1 mL Syringe
FOR SUBCUTANEOUS INJECTION
10 x 150 mg Single Dose Syringes with
Automatic Safety Device
NDC 62037-866-20 ENOXAPARIN SODIUM INJECTION 150 mg/ mL Rx ONLY 1 mL Syringe FOR SUBCUTANEOUS INJECTION 10 x 150 mg Single Dose Syringes with Automatic Safety Device