NDC Compounded Drug 72196-0218-1 Sodium Chloride; Magnesium Sulfate Heptahydrate; Potassium Chloride; Dextrose Monohydrate; Calcium Chloride

Solution Intracoronary

Table of Contents

    1. Compounded Product Information
    2. Frequently Asked Questions

Compounded Drug Product Information

NDC Product Code 72196-0218
NDC Package Code 72196-0218-1
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.		 72196021801
Package Description 1030.2 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.		 Leesburg Cardioplegia
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.		 Leesburg Cardioplegia
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.		 Sodium Chloride; Magnesium Sulfate Heptahydrate; Potassium Chloride; Dextrose Monohydrate; Calcium Chloride
Dosage Form Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Route Name Intracoronary - Administration within the coronary arteries.
Marketing Category OUTSOURCING FACILITY COMPOUNDED HUMAN DRUG PRODUCT (EXEMPT FROM APPROVAL REQUIREMENTS)
Labeler Code 72196
Labeler Name What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		 Central Admixture Pharmacy Services, Inc.
Substance Name Sodium Chloride; Magnesium Sulfate Heptahydrate; Potassium Chloride; Dextrose Monohydrate; Calcium Chloride
Active Ingredients Information 76.92 meq/1030.2 mL; 29.638 meq/1030.2 mL; 40 meq/1030.2 mL; 49.98 g/1030.2 mL; 3.944 meq/1030.2 mL
Reporting Period 2023-2

Frequently Asked Questions

What is the NDC number assigned to Leesburg Cardioplegia?

Leesburg Cardioplegia was assigned by its manufacturer with NDC product code 72196-0218. 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 Leesburg Cardioplegia?

The NDC package code 72196-0218-1 was assigned to a 1030.2 mL in 1 BAG of sodium chloride; magnesium sulfate heptahydrate; potassium chloride; dextrose monohydrate; calcium chloride administered intracoronary via solution.

Who manufactures this product?

Leesburg Cardioplegia is manufactured by an outsourced facility and labeled by Central Admixture Pharmacy Services, 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.