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NDC 11797-0760-06 Enoxaparin Sodium 80 mg/.8mL Details

Enoxaparin Sodium 80 mg/.8mL

Enoxaparin Sodium is a INTRAVENOUS; SUBCUTANEOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Italfarmaco SpA. The primary component is ENOXAPARIN SODIUM.

MedlinePlus Drug Summary

Enoxaparin is used to prevent blood clots in the leg in patients who are on bedrest or who are having hip replacement, knee replacement, or stomach surgery. It is used in combination with aspirin to prevent complications from angina (chest pain) and heart attacks. It is also used in combination with warfarin to treat blood clots in the leg. Enoxaparin is in a class of medications called low molecular weight heparins. It works by stopping the formation of substances that cause clots.

Related Packages: 11797-0760-06
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Enoxaparin Injection

Product Information

NDC	11797-0760
Product ID	11797-760_3102514e-1702-4b7d-9d26-60e98488ffc3
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Enoxaparin Sodium
Proprietary Name Suffix	n/a
Non-Proprietary Name	Enoxaparin Sodium
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	INJECTION, SOLUTION
Route	INTRAVENOUS; SUBCUTANEOUS
Active Ingredient Strength	80
Active Ingredient Units	mg/.8mL
Substance Name	ENOXAPARIN SODIUM
Labeler Name	Italfarmaco SpA
Pharmaceutical Class	Heparin, Low-Molecular-Weight [CS], Low Molecular Weight Heparin [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA076726
Listing Certified Through	2024-12-31

Package

Package Images

NDC 11797-0760-06 (11797076006)

Pricing Information	N/A
NDC Package Code	11797-760-06
Billing NDC	11797076006
Package	10 SYRINGE in 1 CARTON (11797-760-06) / .8 mL in 1 SYRINGE (11797-760-02)
Marketing Start Date	2021-04-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b4d9e4d4-4fdb-48d6-a169-7bc5eebc51e9 Details

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

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	Marketing End 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	Marketing End 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	Marketing End 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	Marketing End 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	Marketing End 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	Marketing End 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	Marketing End 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)

Revised: 11/2022

Document Id: 3102514e-1702-4b7d-9d26-60e98488ffc3

Set id: b4d9e4d4-4fdb-48d6-a169-7bc5eebc51e9

Version: 2

Effective Time: 20221105