NDC Compounded Drug 5446-1341-01 Promethazine Hydrochloride

Ointment Transdermal

Table of Contents

    1. Compounded Product Information
    2. Frequently Asked Questions

Compounded Drug Product Information

NDC Product Code 5446-1341
NDC Package Code 5446-1341-01
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.		 05446134101
Package Description 3 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.		 Promethazine 25mg / 1.2ml 3ml 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.		 Promethazine
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.		 Promethazine Hydrochloride
Dosage Form Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
Route Name Transdermal - Administration through the dermal layer of the skin to the systemic circulation by diffusion.
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 Promethazine Hydrochloride
Active Ingredients Information 25 mg/1.2 mL
Reporting Period 2021-2

Frequently Asked Questions

What is the NDC number assigned to Promethazine 25mg / 1.2ml 3ml Syringe?

Promethazine 25mg / 1.2ml 3ml Syringe was assigned by its manufacturer with NDC product code 5446-1341. 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 Promethazine 25mg / 1.2ml 3ml Syringe?

The NDC package code 5446-1341-01 was assigned to a 3 mL in 1 SYRINGE, PLASTIC of promethazine hydrochloride administered transdermal via ointment.

Who manufactures this product?

Promethazine 25mg / 1.2ml 3ml 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.