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

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code11797-763
Application NumberANDA076726
Product Classification
M
Marketing Category
C73584
G
Generic Name
Enoxaparin Sodium
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateNovember 5, 2022
FDA Product Classification

INGREDIENTS (2)

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

Enoxaparin Sodium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code11797-760
Application NumberANDA076726
Product Classification
M
Marketing Category
C73584
G
Generic Name
Enoxaparin Sodium
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateNovember 5, 2022
FDA Product Classification

INGREDIENTS (2)

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

Enoxaparin Sodium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code11797-758
Application NumberANDA076726
Product Classification
M
Marketing Category
C73584
G
Generic Name
Enoxaparin Sodium
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateNovember 5, 2022
FDA Product Classification

INGREDIENTS (2)

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

Enoxaparin Sodium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code11797-762
Application NumberANDA076726
Product Classification
M
Marketing Category
C73584
G
Generic Name
Enoxaparin Sodium
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateNovember 5, 2022
FDA Product Classification

INGREDIENTS (2)

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

Enoxaparin Sodium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code11797-761
Application NumberANDA076726
Product Classification
M
Marketing Category
C73584
G
Generic Name
Enoxaparin Sodium
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateNovember 5, 2022
FDA Product Classification

INGREDIENTS (2)

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

Enoxaparin Sodium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code11797-757
Application NumberANDA076726
Product Classification
M
Marketing Category
C73584
G
Generic Name
Enoxaparin Sodium
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateNovember 5, 2022
FDA Product Classification

INGREDIENTS (2)

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

Enoxaparin Sodium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code11797-759
Application NumberANDA076726
Product Classification
M
Marketing Category
C73584
G
Generic Name
Enoxaparin Sodium
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateNovember 5, 2022
FDA Product Classification

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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Enoxaparin Sodium - FDA Drug Approval Details