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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

32f8d292-0dda-4931-81ea-ba47e23edf61

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 16, 2023

Manufacturers
FDA

NorthStar Rx LLC

DUNS: 830546433

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 Code16714-006
Application NumberANDA206834
Product Classification
M
Marketing Category
C73584
G
Generic Name
Enoxaparin Sodium
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateDecember 31, 2020
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 Code16714-056
Application NumberANDA206834
Product Classification
M
Marketing Category
C73584
G
Generic Name
Enoxaparin Sodium
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateDecember 31, 2020
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 Code16714-026
Application NumberANDA206834
Product Classification
M
Marketing Category
C73584
G
Generic Name
Enoxaparin Sodium
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateDecember 31, 2020
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 Code16714-066
Application NumberANDA206834
Product Classification
M
Marketing Category
C73584
G
Generic Name
Enoxaparin Sodium
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateDecember 31, 2020
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 Code16714-046
Application NumberANDA206834
Product Classification
M
Marketing Category
C73584
G
Generic Name
Enoxaparin Sodium
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateDecember 31, 2020
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 Code16714-016
Application NumberANDA206834
Product Classification
M
Marketing Category
C73584
G
Generic Name
Enoxaparin Sodium
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateDecember 31, 2020
FDA Product Classification

INGREDIENTS (2)

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

Enoxaparin Sodium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code16714-036
Application NumberANDA206834
Product Classification
M
Marketing Category
C73584
G
Generic Name
Enoxaparin Sodium
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateDecember 31, 2020
FDA Product Classification

INGREDIENTS (2)

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

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