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Enoxaparin Sodium

These highlights do not include all the information needed to use ENOXAPARIN SODIUM injection safely and effectively. See full prescribing information for ENOXAPARIN SODIUM injection. ENOXAPARIN SODIUM injection, for subcutaneous and intravenous use Initial U.S. Approval: 1993

Approved
Approval ID

066f27ec-352c-4051-ba29-248e292690db

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 21, 2022

Manufacturers
FDA

Fresenius Kabi USA, LLC

DUNS: 608775388

Products 8

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 Code63323-533
Application NumberNDA020164
Product Classification
M
Marketing Category
C73605
G
Generic Name
enoxaparin sodium
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateDecember 29, 2021
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 Code63323-535
Application NumberNDA020164
Product Classification
M
Marketing Category
C73605
G
Generic Name
enoxaparin sodium
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateDecember 29, 2021
FDA Product Classification

INGREDIENTS (2)

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

enoxaparin sodium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code63323-605
Application NumberNDA020164
Product Classification
M
Marketing Category
C73605
G
Generic Name
enoxaparin sodium
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateDecember 29, 2021
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 Code63323-607
Application NumberNDA020164
Product Classification
M
Marketing Category
C73605
G
Generic Name
enoxaparin sodium
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateDecember 29, 2021
FDA Product Classification

INGREDIENTS (2)

ENOXAPARIN SODIUMActive
Quantity: 60 mg in 0.6 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 Code63323-539
Application NumberNDA020164
Product Classification
M
Marketing Category
C73605
G
Generic Name
enoxaparin sodium
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRAVENOUS
Effective DateDecember 29, 2021
FDA Product Classification

INGREDIENTS (3)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
ENOXAPARIN SODIUMActive
Quantity: 300 mg in 3 mL
Code: 8NZ41MIK1O
Classification: ACTIB
BENZYL ALCOHOLInactive
Quantity: 45 mg in 3 mL
Code: LKG8494WBH
Classification: IACT

enoxaparin sodium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code63323-537
Application NumberNDA020164
Product Classification
M
Marketing Category
C73605
G
Generic Name
enoxaparin sodium
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateDecember 29, 2021
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 Code63323-609
Application NumberNDA020164
Product Classification
M
Marketing Category
C73605
G
Generic Name
enoxaparin sodium
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateDecember 29, 2021
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 Code63323-531
Application NumberNDA020164
Product Classification
M
Marketing Category
C73605
G
Generic Name
enoxaparin sodium
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateDecember 29, 2021
FDA Product Classification

INGREDIENTS (2)

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

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