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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

38f60bd8-b518-4098-a808-b8f5a3ae6a3a

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 13, 2023

Manufacturers
FDA

Sandoz Inc

DUNS: 005387188

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

NDC Product Code0781-3268
Application NumberANDA077857
Marketing CategoryC73584
Route of AdministrationSUBCUTANEOUS
Effective DateJanuary 23, 2019
Generic NameEnoxaparin Sodium

INGREDIENTS (2)

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

Enoxaparin Sodium

PRODUCT DETAILS

NDC Product Code0781-3298
Application NumberANDA077857
Marketing CategoryC73584
Route of AdministrationSUBCUTANEOUS
Effective DateJanuary 23, 2019
Generic NameEnoxaparin Sodium

INGREDIENTS (2)

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

Enoxaparin Sodium

PRODUCT DETAILS

NDC Product Code0781-3246
Application NumberANDA077857
Marketing CategoryC73584
Route of AdministrationSUBCUTANEOUS
Effective DateJanuary 23, 2019
Generic NameEnoxaparin Sodium

INGREDIENTS (2)

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

Enoxaparin Sodium

PRODUCT DETAILS

NDC Product Code0781-3256
Application NumberANDA077857
Marketing CategoryC73584
Route of AdministrationSUBCUTANEOUS
Effective DateJanuary 23, 2019
Generic NameEnoxaparin Sodium

INGREDIENTS (2)

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

Enoxaparin Sodium

PRODUCT DETAILS

NDC Product Code0781-3262
Application NumberANDA077857
Marketing CategoryC73584
Route of AdministrationSUBCUTANEOUS
Effective DateJanuary 23, 2019
Generic NameEnoxaparin Sodium

INGREDIENTS (2)

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

Enoxaparin Sodium

PRODUCT DETAILS

NDC Product Code0781-3299
Application NumberANDA077857
Marketing CategoryC73584
Route of AdministrationSUBCUTANEOUS
Effective DateJanuary 23, 2019
Generic NameEnoxaparin Sodium

INGREDIENTS (2)

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

Enoxaparin Sodium

PRODUCT DETAILS

NDC Product Code0781-3238
Application NumberANDA077857
Marketing CategoryC73584
Route of AdministrationSUBCUTANEOUS
Effective DateJanuary 23, 2019
Generic NameEnoxaparin Sodium

INGREDIENTS (2)

ENOXAPARIN SODIUMActive
Quantity: 100 mg in 1 mL
Code: 8NZ41MIK1O
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
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Enoxaparin Sodium - FDA Approval | MedPath