NDC Compounded Drug 5446-1416-01 Mitomycin

Solution Irrigation

Table of Contents

    1. Compounded Product Information
    2. Frequently Asked Questions

Compounded Drug Product Information

NDC Product Code 5446-1416
NDC Package Code 5446-1416-01
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.		 05446141601
Package Description 40 mL in 1 SYRINGE, PLASTIC
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.		 Mitomycin 1mg / Ml 60ml Syringe
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.		 Mitomycin
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.		 Mitomycin
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.		 Mitomycin is used to treat various types of cancer (such as stomach/pancreas cancer). It works by slowing or stopping the growth of cancer cells.
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 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
Substance Name Mitomycin
Active Ingredients Information 1 mg/1 mL
Reporting Period 2021-2

Frequently Asked Questions

What is the NDC number assigned to Mitomycin 1mg / Ml 60ml Syringe?

Mitomycin 1mg / Ml 60ml Syringe was assigned by its manufacturer with NDC product code 5446-1416. 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 Mitomycin 1mg / Ml 60ml Syringe?

The NDC package code 5446-1416-01 was assigned to a 40 mL in 1 SYRINGE, PLASTIC of mitomycin administered irrigation via solution.

Who manufactures this product?

Mitomycin 1mg / Ml 60ml Syringe 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.