NDC Compounded Drug 83343-004-15 Edetate Calcium Disodium Trihydrate

Injection, Solution Intravenous

Table of Contents

    1. Compounded Product Information
    2. Frequently Asked Questions

Compounded Drug Product Information

NDC Product Code 83343-004
NDC Package Code 83343-004-15
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.		 83343000415
Package Description 4921 mL in 1 VIAL
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.		 Edetate Calcium Disodium
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.		 Edetate Calcium Disodium
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.		 Edetate Calcium Disodium Trihydrate
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 83343
Labeler Name What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		 Mcguff Outsourcing Solutions Inc.
Substance Name Edetate Calcium Disodium Trihydrate
Active Ingredients Information 200 mg/15 mL
Reporting Period 2023-2

Frequently Asked Questions

What is the NDC number assigned to Edetate Calcium Disodium?

Edetate Calcium Disodium was assigned by its manufacturer with NDC product code 83343-004. 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 Edetate Calcium Disodium?

The NDC package code 83343-004-15 was assigned to a 4921 mL in 1 VIAL of edetate calcium disodium trihydrate administered intravenous via injection, solution.

Who manufactures this product?

Edetate Calcium Disodium is manufactured by an outsourced facility and labeled by Mcguff Outsourcing Solutions 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.