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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 useInitial U.S. Approval: 1993

Approved
Approval ID

adbba7bb-fa72-4cec-aa69-13965591a45d

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 26, 2023

Manufacturers
FDA

Meitheal Pharmaceuticals Inc.

DUNS: 080548348

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 Code71288-432
Application NumberANDA206834
Product Classification
M
Marketing Category
C73584
G
Generic Name
Enoxaparin Sodium
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateJuly 19, 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 Code71288-438
Application NumberANDA206834
Product Classification
M
Marketing Category
C73584
G
Generic Name
Enoxaparin Sodium
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateJuly 19, 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 Code71288-436
Application NumberANDA206834
Product Classification
M
Marketing Category
C73584
G
Generic Name
Enoxaparin Sodium
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateJuly 19, 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 Code71288-433
Application NumberANDA206834
Product Classification
M
Marketing Category
C73584
G
Generic Name
Enoxaparin Sodium
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateJuly 19, 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 Code71288-437
Application NumberANDA206834
Product Classification
M
Marketing Category
C73584
G
Generic Name
Enoxaparin Sodium
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateJuly 19, 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 Code71288-435
Application NumberANDA206834
Product Classification
M
Marketing Category
C73584
G
Generic Name
Enoxaparin Sodium
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateJuly 19, 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 Code71288-434
Application NumberANDA206834
Product Classification
M
Marketing Category
C73584
G
Generic Name
Enoxaparin Sodium
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateJuly 19, 2022
FDA Product Classification

INGREDIENTS (2)

enoxaparin sodiumActive
Quantity: 100 mg in 1 mL
Code: 8NZ41MIK1O
Classification: ACTIB
waterInactive
Code: 059QF0KO0R
Classification: IACT

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