NDC Compounded Drug 5446-0637-01

Concentrate Irrigation

Table of Contents

    1. Compounded Product Information
    2. Frequently Asked Questions

Compounded Drug Product Information

NDC Product Code 5446-0637
NDC Package Code 5446-0637-01
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.		 05446063701
Package Description 300 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.		 Sterile Concentrated Alum Solution
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.		 Alum
Dosage Form Concentrate - A liquid preparation of increased strength and reduced volume which is usually diluted prior to administration.
Route Name Irrigation - Administration to bathe or flush open wounds or body cavities.
Marketing Category OUTSOURCING FACILITY COMPOUNDED HUMAN DRUG PRODUCT (EXEMPT FROM APPROVAL REQUIREMENTS)
Labeler Code 5446
Labeler Name What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		 Edge Pharma Llc
Reporting Period 2021-2

Frequently Asked Questions

What is the NDC number assigned to Sterile Concentrated Alum Solution?

Sterile Concentrated Alum Solution was assigned by its manufacturer with NDC product code 5446-0637. 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 Sterile Concentrated Alum Solution?

The NDC package code 5446-0637-01 was assigned to a 300 mL in 1 BAG of administered irrigation via concentrate.

Who manufactures this product?

Sterile Concentrated Alum Solution is manufactured by an outsourced facility and labeled by Edge Pharma Llc. 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.