Enoxaparin Sodium Injection
NDC Package 63323-539-13

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Enoxaparin Sodium injection is enoxaparin is used to prevent and treat harmful blood clots. This formulation utilizes a injection delivery system. Marketed by Fresenius Kabi Usa, Llc, this product is identified by NDC 63323-539 and is authorized under FDA application NDA020164.

Identification & Billing

NDC Package Code
63323-539-13
Package Description
1 VIAL, MULTI-DOSE in 1 CARTON / 3 mL in 1 VIAL, MULTI-DOSE
Product Code
63323-539
11-Digit Billing Format
63323053913
RxNorm Crosswalk
  • RxCUI: 854228 - enoxaparin sodium 30 MG in 0.3 ML Prefilled Syringe
  • RxCUI: 854228 - 0.3 ML enoxaparin sodium 100 MG/ML Prefilled Syringe
  • RxCUI: 854228 - 0.3 ML ENX sodium 100 MG/ML Prefilled Syringe
  • RxCUI: 854228 - enoxaparin sodium 30 MG per 0.3 ML Prefilled Syringe
  • RxCUI: 854235 - enoxaparin sodium 40 MG in 0.4 ML Prefilled Syringe

Clinical Specifications

Proprietary Name
Enoxaparin Sodium
Non-Proprietary Name
Enoxaparin Sodium
Substance Name
Enoxaparin Sodium
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
  • Intravenous - Administration within or into a vein or veins.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
  • Intravenous - Administration within or into a vein or veins.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Enoxaparin is used to prevent and treat harmful blood clots. This helps to reduce the risk of a stroke or heart attack. This medication helps keep your blood flowing smoothly by lowering the activity of clotting proteins in the blood. Enoxaparin is an anticoagulant, also known as a "blood thinner." It is a type of heparin. Conditions which increase your risk of developing blood clots include certain types of surgeries (such as knee/hip replacement, abdominal), long periods of being immobile, certain types of heart attack, and a specific type of chest pain called unstable angina. For some medical conditions, enoxaparin may be used in combination with other "blood thinners."

Regulatory & Marketing

Labeler Name
Fresenius Kabi Usa, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA020164
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
06-18-2019
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (63323-539). Click a package code to view its specific billing and regulatory data.

63323-539-03
1 VIAL, MULTI-DOSE in 1 CARTON / 3 mL in 1 VIAL, MULTI-DOSE

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 63323-539-13 identifies a specific commercial package of 1 vial, multi-dose in 1 carton / 3 ml in 1 vial, multi-dose of Enoxaparin Sodium, a human prescription drug labeled by Fresenius Kabi Usa, Llc. This injection is formulated for intravenous; subcutaneous use and contains enoxaparin sodium as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Fresenius Kabi Usa, Llc on June 18, 2019. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Enoxaparin is used to prevent and treat harmful blood clots. This helps to reduce the risk of a stroke or heart attack. This medication helps keep your blood flowing smoothly by lowering the activity of clotting proteins in the blood. Enoxaparin is an anticoagulant, also known as a "blood thinner." It is a type of heparin. Conditions which increase your risk of developing blood clots include certain types of surgeries (such as knee/hip replacement, abdominal), long periods of being immobile, certain types of heart attack, and a specific type of chest pain called unstable angina. For some medical conditions, enoxaparin may be used in combination with other "blood thinners."

How is this Fresenius Kabi Usa, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63323053913. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
63323-539-13
11-Digit CMS (5-4-2)
63323-0539-13

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.