Heparin Sodium Injection
NDC Package 68083-428-25

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 delivery system. Marketed by Gland Pharma Limited, this product is identified by NDC 68083-428 and is authorized under FDA application ANDA205323.

Identification & Billing

NDC Package Code
68083-428-25
Package Description
25 VIAL, MULTI-DOSE in 1 CARTON / 30 mL in 1 VIAL, MULTI-DOSE (68083-428-01)
Product Code
68083-428
11-Digit Billing Format
68083042825
RxNorm Crosswalk
  • RxCUI: 1361226 - heparin sodium, porcine 1000 UNT/ML Injectable Solution
  • RxCUI: 1361615 - heparin sodium, porcine 5000 UNT/ML Injectable Solution

Clinical Specifications

Proprietary Name
Heparin Sodium
Non-Proprietary Name
Heparin Sodium
Substance Name
Heparin 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.
Active Ingredient(s)
HEPARIN SODIUM 1000 [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
Gland Pharma Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA205323
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-18-2019
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 68083-428-25 identifies a specific commercial package of 25 vial, multi-dose in 1 carton / 30 ml in 1 vial, multi-dose (68083-428-01) of Heparin Sodium, a human prescription drug labeled by Gland Pharma Limited. This injection 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 Gland Pharma Limited on November 18, 2019. 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 Gland Pharma Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68083042825. 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)
68083-428-25
11-Digit CMS (5-4-2)
68083-0428-25

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