MedPath

Enoxaparin Sodium

ENOXAPARIN SODIUM injection, for subcutaneous and intravenous use

Approved
Approval ID

b4d9e4d4-4fdb-48d6-a169-7bc5eebc51e9

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 5, 2022

Manufacturers
FDA

Italfarmaco SpA

DUNS: 428179329

Products 7

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Enoxaparin Sodium

PRODUCT DETAILS

NDC Product Code11797-763
Application NumberANDA076726
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateNovember 5, 2022
Generic NameEnoxaparin Sodium

INGREDIENTS (2)

ENOXAPARIN SODIUMActive
Quantity: 150 mg in 1 mL
Code: 8NZ41MIK1O
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Enoxaparin Sodium

PRODUCT DETAILS

NDC Product Code11797-760
Application NumberANDA076726
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateNovember 5, 2022
Generic NameEnoxaparin Sodium

INGREDIENTS (2)

ENOXAPARIN SODIUMActive
Quantity: 80 mg in 0.8 mL
Code: 8NZ41MIK1O
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Enoxaparin Sodium

PRODUCT DETAILS

NDC Product Code11797-758
Application NumberANDA076726
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateNovember 5, 2022
Generic NameEnoxaparin Sodium

INGREDIENTS (2)

ENOXAPARIN SODIUMActive
Quantity: 40 mg in 0.4 mL
Code: 8NZ41MIK1O
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Enoxaparin Sodium

PRODUCT DETAILS

NDC Product Code11797-762
Application NumberANDA076726
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateNovember 5, 2022
Generic NameEnoxaparin Sodium

INGREDIENTS (2)

ENOXAPARIN SODIUMActive
Quantity: 120 mg in 0.8 mL
Code: 8NZ41MIK1O
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Enoxaparin Sodium

PRODUCT DETAILS

NDC Product Code11797-761
Application NumberANDA076726
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateNovember 5, 2022
Generic NameEnoxaparin Sodium

INGREDIENTS (2)

ENOXAPARIN SODIUMActive
Quantity: 100 mg in 1 mL
Code: 8NZ41MIK1O
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Enoxaparin Sodium

PRODUCT DETAILS

NDC Product Code11797-757
Application NumberANDA076726
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateNovember 5, 2022
Generic NameEnoxaparin Sodium

INGREDIENTS (2)

ENOXAPARIN SODIUMActive
Quantity: 30 mg in 0.3 mL
Code: 8NZ41MIK1O
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Enoxaparin Sodium

PRODUCT DETAILS

NDC Product Code11797-759
Application NumberANDA076726
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateNovember 5, 2022
Generic NameEnoxaparin Sodium

INGREDIENTS (2)

ENOXAPARIN SODIUMActive
Quantity: 60 mg in 0.6 mL
Code: 8NZ41MIK1O
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 3/30/2021

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

30 mg

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

40 mg

NDC11797-759-06

Enoxaparin Sodium Injection USP

60 mg/0.6 mL

SINGLE-DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE

FOR SUBCUTANEOUS INJECTION

Ten 0.6 mL Syringes

60 mg

NDC11797-760-06

Enoxaparin Sodium Injection USP

80 mg/0.8 mL

SINGLE-DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE

FOR SUBCUTANEOUS INJECTION

Ten 0.8 mL Syringes

80 mg

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

100 mg

NDC11797-762-06

Enoxaparin Sodium Injection USP

120 mg/0.8 mL

SINGLE-DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE

FOR SUBCUTANEOUS INJECTION

Ten 0.8 mL Syringes

120 mg

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

150 mg

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 3/30/2021
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