PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 11797-757-06

Enoxaparin Sodium Injection USP

30 mg/0.3 mL

SINGLE-DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE

FOR SUBCUTANEOUS INJECTION

Ten 0.3 mL Syringes

NDC 11797-758-06

Enoxaparin Sodium Injection USP

40 mg/0.4 mL

SINGLE-DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE

FOR SUBCUTANEOUS INJECTION

Ten 0.4 mL Syringes

NDC 11797-759-06

Enoxaparin Sodium Injection USP

60 mg/0.6 mL

SINGLE-DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE

FOR SUBCUTANEOUS INJECTION

Ten 0.6 mL Syringes

NDC 11797-760-06

Enoxaparin Sodium Injection USP

80 mg/0.8 mL

SINGLE-DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE

FOR SUBCUTANEOUS INJECTION

Ten 0.8 mL Syringes

NDC 11797-761-06

Enoxaparin Sodium Injection USP

100 mg/1 mL

SINGLE-DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE

FOR SUBCUTANEOUS INJECTION

Ten 1 mL Syringes

NDC 11797-762-06

Enoxaparin Sodium Injection USP

120 mg/0.8 mL

SINGLE-DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE

FOR SUBCUTANEOUS INJECTION

Ten 0.8 mL Syringes

NDC 11797-763-06

Enoxaparin Sodium Injection USP

150 mg/1 mL

SINGLE-DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE

FOR SUBCUTANEOUS INJECTION

Ten 1 mL Syringes

ENOXAPARIN SODIUM
enoxaparin sodium injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:11797-757
Route of Administration	INTRAVENOUS, SUBCUTANEOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ENOXAPARIN SODIUM (UNII: 8NZ41MIK1O) (ENOXAPARIN - UNII:E47C0NF7LV)	ENOXAPARIN SODIUM	30 mg in 0.3 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:11797-757-06	10 in 1 CARTON	04/01/2021
1	NDC:11797-757-02	0.3 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA076726	04/01/2021

ENOXAPARIN SODIUM
enoxaparin sodium injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:11797-758
Route of Administration	INTRAVENOUS, SUBCUTANEOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ENOXAPARIN SODIUM (UNII: 8NZ41MIK1O) (ENOXAPARIN - UNII:E47C0NF7LV)	ENOXAPARIN SODIUM	40 mg in 0.4 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:11797-758-06	10 in 1 CARTON	04/01/2021
1	NDC:11797-758-02	0.4 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA076726	04/01/2021

ENOXAPARIN SODIUM
enoxaparin sodium injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:11797-759
Route of Administration	INTRAVENOUS, SUBCUTANEOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ENOXAPARIN SODIUM (UNII: 8NZ41MIK1O) (ENOXAPARIN - UNII:E47C0NF7LV)	ENOXAPARIN SODIUM	60 mg in 0.6 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:11797-759-06	10 in 1 CARTON	04/01/2021
1	NDC:11797-759-02	0.6 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA076726	04/01/2021

ENOXAPARIN SODIUM
enoxaparin sodium injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:11797-760
Route of Administration	INTRAVENOUS, SUBCUTANEOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ENOXAPARIN SODIUM (UNII: 8NZ41MIK1O) (ENOXAPARIN - UNII:E47C0NF7LV)	ENOXAPARIN SODIUM	80 mg in 0.8 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:11797-760-06	10 in 1 CARTON	04/01/2021
1	NDC:11797-760-02	0.8 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA076726	04/01/2021

ENOXAPARIN SODIUM
enoxaparin sodium injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:11797-761
Route of Administration	INTRAVENOUS, SUBCUTANEOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ENOXAPARIN SODIUM (UNII: 8NZ41MIK1O) (ENOXAPARIN - UNII:E47C0NF7LV)	ENOXAPARIN SODIUM	100 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:11797-761-06	10 in 1 CARTON	04/01/2021
1	NDC:11797-761-02	1 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA076726	04/01/2021

ENOXAPARIN SODIUM
enoxaparin sodium injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:11797-762
Route of Administration	INTRAVENOUS, SUBCUTANEOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ENOXAPARIN SODIUM (UNII: 8NZ41MIK1O) (ENOXAPARIN - UNII:E47C0NF7LV)	ENOXAPARIN SODIUM	120 mg in 0.8 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:11797-762-06	10 in 1 CARTON	04/01/2021
1	NDC:11797-762-02	0.8 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA076726	04/01/2021

ENOXAPARIN SODIUM
enoxaparin sodium injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:11797-763
Route of Administration	INTRAVENOUS, SUBCUTANEOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ENOXAPARIN SODIUM (UNII: 8NZ41MIK1O) (ENOXAPARIN - UNII:E47C0NF7LV)	ENOXAPARIN SODIUM	150 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:11797-763-06	10 in 1 CARTON	04/01/2021
1	NDC:11797-763-02	1 mL in 1 SYRINGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA076726	04/01/2021

Labeler - Italfarmaco SpA (428179329)

Name	Address	ID/FEI	Business Operations
Establishment
Italfarmaco SpA		428179329	MANUFACTURE(11797-757, 11797-758, 11797-759, 11797-760, 11797-761, 11797-762, 11797-763)

ENOXAPARIN SODIUM injection, for subcutaneous and intravenous use

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL