NDC Code(s) : 70710-1757-2, 70710-1757-6, 70710-1758-2, 70710-1758-6, 70710-1759-2, 70710-1759-6, 70710-1760-2, 70710-1760-6, 70710-1761-2, 70710-1761-6, 70710-1762-2, 70710-1762-6, 70710-1763-2, 70710-1763-6
Packager : Zydus Pharmaceuticals USA Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Enoxaparin SodiumEnoxaparin Sodium INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70710-1757
Route of Administration INTRAVENOUS, 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:70710-1757-610 in 1 CARTON 04/01/2021
1NDC:70710-1757-20.3 mL in 1 SYRINGE Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076726 04/01/2021
Enoxaparin SodiumEnoxaparin Sodium INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70710-1758
Route of Administration INTRAVENOUS, 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:70710-1758-610 in 1 CARTON 04/01/2021
1NDC:70710-1758-20.4 mL in 1 SYRINGE Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076726 04/01/2021
Enoxaparin SodiumEnoxaparin Sodium INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70710-1759
Route of Administration INTRAVENOUS, 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:70710-1759-610 in 1 CARTON 04/01/2021
1NDC:70710-1759-20.6 mL in 1 SYRINGE Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076726 04/01/2021
Enoxaparin SodiumEnoxaparin Sodium INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70710-1760
Route of Administration INTRAVENOUS, 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:70710-1760-610 in 1 CARTON 04/01/2021
1NDC:70710-1760-20.8 mL in 1 SYRINGE Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076726 04/01/2021
Enoxaparin SodiumEnoxaparin Sodium INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70710-1761
Route of Administration INTRAVENOUS, 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:70710-1761-610 in 1 CARTON 04/01/2021
1NDC:70710-1761-21 mL in 1 SYRINGE Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076726 04/01/2021
Enoxaparin SodiumEnoxaparin Sodium INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70710-1762
Route of Administration INTRAVENOUS, 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:70710-1762-610 in 1 CARTON 04/01/2021
1NDC:70710-1762-20.8 mL in 1 SYRINGE Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076726 04/01/2021
Enoxaparin SodiumEnoxaparin Sodium INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70710-1763
Route of Administration INTRAVENOUS, 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:70710-1763-610 in 1 CARTON 04/01/2021
1NDC:70710-1763-21 mL in 1 SYRINGE Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076726 04/01/2021

LABELER - Zydus Pharmaceuticals USA Inc.(156861945)

REGISTRANT - Zydus Pharmaceuticals USA Inc.(156861945)

Establishment
Name Address ID/FEI Business Operations
Italfarmaco SpA 428179329 MANUFACTURE(70710-1757, 70710-1758, 70710-1759, 70710-1760, 70710-1761, 70710-1762, 70710-1763)

PRINCIPAL DISPLAY PANEL

NDC 70710-1757-6

Enoxaparin Sodium Injection USP

30 mg/0.3 mL

SINGLE-DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE

FOR SUBCUTANEOUS INJECTION

Ten 0.3 mL Syringes

Zydus

Image

PRINCIPAL DISPLAY PANEL

NDC 70710-1758-6

Enoxaparin Sodium Injection USP

40 mg/0.4 mL

SINGLE-DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE

FOR SUBCUTANEOUS INJECTION

Ten 0.4 mL Syringes

Zydus

Image

PRINCIPAL DISPLAY PANEL

NDC 70710-1759-6

Enoxaparin Sodium Injection USP

60 mg/0.6 mL

SINGLE-DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE

FOR SUBCUTANEOUS INJECTION

Ten 0.6 mL Syringes

Zydus

Image

PRINCIPAL DISPLAY PANEL

NDC 70710-1760-6

Enoxaparin Sodium Injection USP

80 mg/0.8 mL

SINGLE-DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE

FOR SUBCUTANEOUS INJECTION

Ten 0.8 mL Syringes

Zydus

Image

PRINCIPAL DISPLAY PANEL

NDC 70710-1761-6

Enoxaparin Sodium Injection USP

100 mg/1 mL

SINGLE-DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE

FOR SUBCUTANEOUS INJECTION

Ten 1 mL Syringes

Zydus

Image

PRINCIPAL DISPLAY PANEL

NDC 70710-1762-6

Enoxaparin Sodium Injection USP

120 mg/0.8 mL

SINGLE-DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE

FOR SUBCUTANEOUS INJECTION

Ten 0.8 mL Syringes

Zydus

Image

PRINCIPAL DISPLAY PANEL

NDC 70710-1763-6

Enoxaparin Sodium Injection USP

150 mg/1 mL

SINGLE-DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE

FOR SUBCUTANEOUS INJECTION

Ten 1 mL Syringes

Zydus

image