Heparin Sodium Injection, Solution
NDC Package 76045-108-10

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

Package Information

Heparin Sodium injection is a medication used to prevent and treat blood clots. This formulation utilizes a injection, solution delivery system. Marketed by Fresenius Kabi Usa, Llc, this product is identified by NDC 76045-108 and is authorized under FDA application ANDA206552.

Identification & Billing

NDC Package Code
76045-108-10
Package Description
24 BLISTER PACK in 1 CARTON / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-108-00) / 1 mL in 1 SYRINGE, GLASS
Product Code
76045-108
11-Digit Billing Format
76045010810
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 1798389 - heparin sodium, porcine 5000 UNT in 1 ML Prefilled Syringe
  • RxCUI: 1798389 - 1 ML heparin sodium, porcine 5000 UNT/ML Prefilled Syringe
  • RxCUI: 1798389 - heparin sodium, porcine 5000 UNT per 1 ML Prefilled Syringe

Clinical Specifications

Proprietary Name
Heparin Sodium
Non-Proprietary Name
Heparin Sodium
Substance Name
Heparin Sodium
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
  • Intravenous - Administration within or into a vein or veins.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
HEPARIN SODIUM 5000 [USP'U]/mL
Pharmacologic Class
Usage Information
This medication is used to prevent and treat blood clots. It may be used to prevent and treat blood clots in the lungs/legs (including in patients with atrial fibrillation). It may be used to treat certain blood clotting disorders. It may also be used to prevent blood clots after surgery, during dialysis, during blood transfusions, when collecting blood samples, or when a person is unable to move for a long time. Heparin helps to keep blood flowing smoothly by making a certain natural substance in your body (anti-clotting protein) work better. It is known as an anticoagulant.

Regulatory & Marketing

Labeler Name
Fresenius Kabi Usa, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA206552
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-10-2016
Listing Expiration
12-31-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 76045-108-10 identifies a specific commercial package of 24 blister pack in 1 carton / 1 syringe, glass in 1 blister pack (76045-108-00) / 1 ml in 1 syringe, glass of Heparin Sodium, a human prescription drug labeled by Fresenius Kabi Usa, Llc. This injection, solution is formulated for intravenous; subcutaneous use and contains heparin 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 10, 2016. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to prevent and treat blood clots. It may be used to prevent and treat blood clots in the lungs/legs (including in patients with atrial fibrillation). It may be used to treat certain blood clotting disorders. It may also be used to prevent blood clots after surgery, during dialysis, during blood transfusions, when collecting blood samples, or when a person is unable to move for a long time. Heparin helps to keep blood flowing smoothly by making a certain natural substance in your body (anti-clotting protein) work better. It is known as an anticoagulant.

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: 76045010810. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
76045-108-10
11-Digit CMS (5-4-2)
76045-0108-10

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