NDC Compounded Drug 82396-135-01 Heparin Sodium

Injection, Solution Intravenous

Table of Contents

    1. Compounded Product Information
    2. Frequently Asked Questions

Compounded Drug Product Information

NDC Product Code 82396-135
NDC Package Code 82396-135-01
11-Digit NDC Billing Format NDC Format for Billing
For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.		 82396013501
Package Description 1000 mL in 1 BAG
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.		 Human Compounded Drug
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.		 Heparin Sodium
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.		 Heparin Sodium
Substance Name What is the Substance Name?
An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.		 Heparin Sodium
Usage Information Product Usage Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.		 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.
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.
Route Name Intravenous - Administration within or into a vein or veins.
Marketing Category OUTSOURCING FACILITY COMPOUNDED HUMAN DRUG PRODUCT (EXEMPT FROM APPROVAL REQUIREMENTS)
Labeler Code 82396
Labeler Name What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		 Annovex Pharma, Inc.
Substance Name Heparin Sodium
Active Ingredients Information 5000 U/1 mL
Reporting Period 2024-1

Frequently Asked Questions

What is the NDC number assigned to Heparin Sodium?

Heparin Sodium was assigned by its manufacturer with NDC product code 82396-135. This product is a drug classified as a human compounded drug. Compounded drugs are medications created by combining or altering existing drugs to meet the specific needs of certain patients. The NDC directory only includes information about compounded drugs from facilities that choose to assign NDC numbers to their products.

Which are the NDC package codes for Heparin Sodium?

The NDC package code 82396-135-01 was assigned to a 1000 mL in 1 BAG of heparin sodium administered intravenous via injection, solution.

Who manufactures this product?

Heparin Sodium is manufactured by an outsourced facility and labeled by Annovex Pharma, Inc.. All compounded drugs included in the NDC directory are classified as "Outsourcing Facility Compounded Human Drug Product (Exempt from Approval Requirements)". Outsourcing facilities are a type of drug compounding facility regulated under Section 503B of the FD&C Act could be eligible for exemptions from drug registration if they meet all the conditions specified under Section 503B.