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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. njection, for subcutaneous useInitial U.S. Approval: 1993

Approved
Approval ID

2aa00290-df66-2c10-6711-8f0a22e33ded

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 21, 2023

Manufacturers
FDA

Apotex Corp.

DUNS: 845263701

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 Code60505-0793
Application NumberANDA078990
Product Classification
M
Marketing Category
C73584
G
Generic Name
enoxaparin sodium
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateJuly 21, 2023
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 Code60505-0791
Application NumberANDA078990
Product Classification
M
Marketing Category
C73584
G
Generic Name
enoxaparin sodium
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateJuly 21, 2023
FDA Product Classification

INGREDIENTS (2)

WaterInactive
Code: 059QF0KO0R
Classification: IACT
enoxaparin sodiumActive
Quantity: 30 mg in 0.3 mL
Code: 8NZ41MIK1O
Classification: ACTIB

enoxaparin sodium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code60505-0798
Application NumberANDA078990
Product Classification
M
Marketing Category
C73584
G
Generic Name
enoxaparin sodium
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateJuly 21, 2023
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 Code60505-0794
Application NumberANDA078990
Product Classification
M
Marketing Category
C73584
G
Generic Name
enoxaparin sodium
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateJuly 21, 2023
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 Code60505-0795
Application NumberANDA078990
Product Classification
M
Marketing Category
C73584
G
Generic Name
enoxaparin sodium
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateJuly 21, 2023
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 Code60505-0796
Application NumberANDA078990
Product Classification
M
Marketing Category
C73584
G
Generic Name
enoxaparin sodium
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateJuly 21, 2023
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 Code60505-0792
Application NumberANDA078990
Product Classification
M
Marketing Category
C73584
G
Generic Name
enoxaparin sodium
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateJuly 21, 2023
FDA Product Classification

INGREDIENTS (2)

enoxaparin sodiumActive
Quantity: 40 mg in 0.4 mL
Code: 8NZ41MIK1O
Classification: ACTIB
WaterInactive
Code: 059QF0KO0R
Classification: IACT

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Enoxaparin Sodium - FDA Drug Approval Details