NDC Code(s) : 0075-0624-31, 0075-0620-41, 0075-0621-61, 0075-0622-81, 0075-0623-01, 0075-0626-04, 0075-2912-02, 0075-2915-02
Packager : sanofi-aventis U.S. LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Lovenoxenoxaparin sodium INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0075-0624
Route of Administration SUBCUTANEOUS, INTRAVENOUS 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:0075-0624-3110 in 1 CARTON 12/03/2008
10.3 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
NDA NDA020164 03/12/2008
Lovenoxenoxaparin sodium INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0075-0620
Route of Administration SUBCUTANEOUS, INTRAVENOUS 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:0075-0620-4110 in 1 CARTON 12/03/2008
10.4 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
NDA NDA020164 03/12/2008
Lovenoxenoxaparin sodium INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0075-0621
Route of Administration SUBCUTANEOUS, INTRAVENOUS 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:0075-0621-6110 in 1 CARTON 17/04/2008
10.6 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
NDA NDA020164 04/17/2008
Lovenoxenoxaparin sodium INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0075-0622
Route of Administration SUBCUTANEOUS, INTRAVENOUS 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:0075-0622-8110 in 1 CARTON 21/04/2008
10.8 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
NDA NDA020164 04/21/2008
Lovenoxenoxaparin sodium INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0075-0623
Route of Administration SUBCUTANEOUS, INTRAVENOUS 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:0075-0623-0110 in 1 CARTON 21/04/2008
11 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
NDA NDA020164 04/21/2008
Lovenoxenoxaparin sodium INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0075-0626
Route of Administration SUBCUTANEOUS, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
enoxaparin sodium(UNII: 8NZ41MIK1O)
(enoxaparin - UNII:E47C0NF7LV) 		enoxaparin sodium300 mg in 3 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:0075-0626-041 in 1 CARTON 21/04/2008
13 mL in 1 VIAL, MULTI-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020164 04/21/2008
Lovenoxenoxaparin sodium INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0075-2912
Route of Administration SUBCUTANEOUS, INTRAVENOUS 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:0075-2912-0210 in 1 CARTON 21/04/2008
10.8 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
NDA NDA020164 04/21/2008
Lovenoxenoxaparin sodium INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0075-2915
Route of Administration SUBCUTANEOUS, INTRAVENOUS 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:0075-2915-0210 in 1 CARTON 21/04/2008
11 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
NDA NDA020164 04/21/2008

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 30mg/0.3mL Carton

NDC 0075-0624-31

Lovenox®
(enoxaparin sodium injection)

30mg/0.3mL

Rx ONLY

SINGLE DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE

FOR SUBCUTANEOUS INJECTION

Ten 0.3mL Syringes

NOVAPLUS™

PRINCIPAL DISPLAY PANEL - 30mg/0.3mL Carton

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 40mg/0.4mL Carton

NDC 0075-0620-41

Lovenox®
(enoxaparin sodium injection)

40mg/0.4mL

Rx ONLY

SINGLE DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE

FOR SUBCUTANEOUS INJECTION

Ten 0.4mL Syringes

NOVAPLUS™

PRINCIPAL DISPLAY PANEL - 40mg/0.4mL Carton

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 60mg/0.6mL Carton

NDC 0075-0621-61

Lovenox®
(enoxaparin sodium injection)

60mg/0.6mL

Rx ONLY

SINGLE DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE

FOR SUBCUTANEOUS INJECTION

Ten 0.6mL Syringes

NOVAPLUS™

PRINCIPAL DISPLAY PANEL - 60mg/0.6mL Carton

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 80mg/0.8mL Carton

NDC 0075-0622-81

Lovenox®
(enoxaparin sodium injection)

80mg/0.8mL

Rx ONLY

SINGLE DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE

FOR SUBCUTANEOUS INJECTION

Ten 0.8mL Syringes

NOVAPLUS™

PRINCIPAL DISPLAY PANEL - 80mg/0.8mL Carton

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 100mg/1mL Carton

NDC 0075-0623-01

Lovenox®
(enoxaparin sodium injection)

100mg/1mL

Rx ONLY

SINGLE DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE

FOR SUBCUTANEOUS INJECTION

Ten 1mL Syringes

NOVAPLUS™

PRINCIPAL DISPLAY PANEL - 100mg/1mL Carton

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 300mg/3mL Carton

NDC 0075-0626-04

Lovenox®
(enoxaparin sodium injection)

300mg/3mL
(100mg/1mL)

Rx ONLY

For Subcutaneous or
Intravenous Injection

Multiple Dose Vial

One 3mL Vial

NOVAPLUS™

PRINCIPAL DISPLAY PANEL - 300mg/3mL Carton

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 120mg/0.8mL Carton

NDC 0075-2912-02

Lovenox®
(enoxaparin sodium injection)

120mg/0.8mL

Rx ONLY

SINGLE DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE

FOR SUBCUTANEOUS INJECTION

Ten 0.8mL Syringes

NOVAPLUS™

PRINCIPAL DISPLAY PANEL - 120mg/0.8mL Carton

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 150mg/1mL Carton

NDC 0075-2915-02

Lovenox®
(enoxaparin sodium injection)

150mg/1mL

Rx ONLY

SINGLE DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE

FOR SUBCUTANEOUS INJECTION

Ten 1mL Syringes

NOVAPLUS™

PRINCIPAL DISPLAY PANEL - 150mg/1mL Carton