NDC Code(s) : 71839-109-10, 71839-110-10, 71839-111-10, 71839-112-10, 71839-113-10, 71839-115-10, 71839-116-10
Packager : BE Pharmaceuticals Inc.

Category : Human Prescription Drug Label

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

enoxaparin sodium enoxaparin sodium INJECTION
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:71839-109
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:71839-109-1010 in 1 CARTON 16/06/2023
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
ANDA ANDA214646 06/16/2023
enoxaparin sodium enoxaparin sodium INJECTION
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:71839-110
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:71839-110-1010 in 1 CARTON 16/06/2023
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
ANDA ANDA214646 06/16/2023
enoxaparin sodium enoxaparin sodium INJECTION
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:71839-111
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:71839-111-1010 in 1 CARTON 16/06/2023
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
ANDA ANDA214646 06/16/2023
enoxaparin sodium enoxaparin sodium INJECTION
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:71839-112
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:71839-112-1010 in 1 CARTON 16/06/2023
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
ANDA ANDA214646 06/16/2023
enoxaparin sodium enoxaparin sodium INJECTION
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:71839-113
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:71839-113-1010 in 1 CARTON 16/06/2023
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
ANDA ANDA214646 06/16/2023
enoxaparin sodium enoxaparin sodium INJECTION
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:71839-115
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:71839-115-1010 in 1 CARTON 16/06/2023
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
ANDA ANDA214646 06/16/2023
enoxaparin sodium enoxaparin sodium INJECTION
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:71839-116
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:71839-116-1010 in 1 CARTON 16/06/2023
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
ANDA ANDA214646 06/16/2023

LABELER - BE Pharmaceuticals Inc.(081499296)

Establishment
Name Address ID/FEI Business Operations
Biological E. Limited 871410645 ANALYSIS(71839-109, 71839-110, 71839-111, 71839-112, 71839-113, 71839-115, 71839-116), MANUFACTURE(71839-109, 71839-110, 71839-111, 71839-112, 71839-113, 71839-115, 71839-116)

PRINCIPAL DISPLAY PANEL

Enoxaparin Sodium Injection USP, 100 mg/mL (30 mg/0.3 mL) - PFS Label
PFS Label

Enoxaparin Sodium Injection USP, 100 mg/mL (40 mg/0.4 mL) - PFS Label
PFS Label

Enoxaparin Sodium Injection USP, 100 mg/mL (60 mg/0.6mL) - PFS Label
PFS Label

Enoxaparin Sodium Injection USP, 100 mg/mL (80 mg/0.8 mL) - PFS Label
PFS Label

Enoxaparin Sodium Injection USP, 100 mg/mL (100 mg/1 mL) - PFS Label
PFS Label

Enoxaparin Sodium Injection USP, 150 mg/mL (120 mg/0.8 mL) - PFS Label
PFS Label

 Enoxaparin Sodium Injection USP, 150 mg/mL (150 mg/1 mL) - PFS Label
PFS Label

Enoxaparin Sodium Injection USP, 100 mg/mL (30 mg/0.3 mL) - Blister Label

  

PFS Label

 

 Enoxaparin Sodium Injection USP, 100 mg/mL (40 mg/0.4 mL)  - Blister Label
PFS Label
Enoxaparin Sodium Injection USP, 100 mg/mL (60 mg/0.6 mL)  - Blister Label
 PFS Label

Enoxaparin Sodium Injection USP, 100 mg/mL (80 mg/0.8 mL)  - Blister Label

 

PFS Label


 Enoxaparin Sodium Injection USP, 100 mg/mL (100 mg/1 mL)  - Blister Label

PFS Label

 



Enoxaparin Sodium Injection USP, 150 mg/mL (120 mg/0.8 mL)  - Blister Label
PFS Label

 Enoxaparin Sodium Injection USP, 150 mg/mL (150 mg/1 mL)  - Blister Label
PFS Label

Enoxaparin Sodium Injection USP, 100 mg/mL (30 mg/0.3 mL) - Carton Label

  

PFS Label


Enoxaparin Sodium Injection USP, 100 mg/mL (40 mg/0.4 mL) - Carton Label
PFS Label
Enoxaparin Sodium Injection USP, 100 mg/mL (60 mg/0.6 mL) - Carton Label
 PFS Label

 Enoxaparin Sodium Injection USP, 100 mg/mL (80 mg/0.8 mL) - Carton Label
PFS Label

 Enoxaparin Sodium Injection USP, 100 mg/mL (100 mg/1 mL) - Carton Label
PFS Label

 Enoxaparin Sodium Injection USP, 150 mg/mL (120 mg/0.8 mL) - Carton Label
PFS Label

 Enoxaparin Sodium Injection USP, 150 mg/mL (150 mg/1 mL) - Carton Label

PFS Label