NDC Compounded Drug 5446-0607-01 Lidocaine; Racepinephrine; Tetracaine Hydrochloride

Gel Topical

Table of Contents

    1. Compounded Product Information
    2. Frequently Asked Questions

Compounded Drug Product Information

NDC Product Code 5446-0607
NDC Package Code 5446-0607-01
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.		 05446060701
Package Description 5 mL in 1 SYRINGE
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.		 Lidocaine 4% / Epinephrine 0.05% / Tetracaine 0.5% 3ml, 5ml 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.		 Lidocaine / Epinephrine / Tetracaine
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.		 Lidocaine; Racepinephrine; Tetracaine Hydrochloride
Dosage Form Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
Route Name Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
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 Lidocaine; Racepinephrine; Tetracaine Hydrochloride
Active Ingredients Information 40 mg/1 mL; .5 mg/1 mL; 5 mg/1 mL
Reporting Period 2021-2

Frequently Asked Questions

What is the NDC number assigned to Lidocaine 4% / Epinephrine 0.05% / Tetracaine 0.5% 3ml, 5ml Syringe?

Lidocaine 4% / Epinephrine 0.05% / Tetracaine 0.5% 3ml, 5ml Syringe was assigned by its manufacturer with NDC product code 5446-0607. 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 Lidocaine 4% / Epinephrine 0.05% / Tetracaine 0.5% 3ml, 5ml Syringe?

The NDC package code 5446-0607-01 was assigned to a 5 mL in 1 SYRINGE of lidocaine; racepinephrine; tetracaine hydrochloride administered topical via gel.

Who manufactures this product?

Lidocaine 4% / Epinephrine 0.05% / Tetracaine 0.5% 3ml, 5ml 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.