NDC Compounded Drug 72627-2506-3 Papaverine Hydrochloride; Phentolamine Mesylate; Alprostadil

Injection, Powder, Lyophilized, For Solution Intracavernous

Table of Contents

    1. Compounded Product Information
    2. Frequently Asked Questions

Compounded Drug Product Information

NDC Product Code 72627-2506
NDC Package Code 72627-2506-3
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.		 72627250603
Package Description 5 mL in 1 VIAL, MULTI-DOSE
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.		 Papeverine Hcl/phenoloamine Mesylate/prostaglandin E1
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.		 Papeverine Hcl/phenoloamine Mesylate/prostaglandin E1
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.		 Papaverine Hydrochloride; Phentolamine Mesylate; Alprostadil
Dosage Form Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
Route Name Intracavernous - Administration within a pathologic cavity, such as occurs in the lung in tuberculosis.
Marketing Category OUTSOURCING FACILITY COMPOUNDED HUMAN DRUG PRODUCT (EXEMPT FROM APPROVAL REQUIREMENTS)
Labeler Code 72627
Labeler Name What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		 Empower Pharmacy
Substance Name Papaverine Hydrochloride; Phentolamine Mesylate; Alprostadil
Active Ingredients Information 30 mg/1 mL; 2 mg/1 mL; .02 mg/1 mL
Reporting Period 2022-2

Frequently Asked Questions

What is the NDC number assigned to Papeverine Hcl/phenoloamine Mesylate/prostaglandin E1?

Papeverine Hcl/phenoloamine Mesylate/prostaglandin E1 was assigned by its manufacturer with NDC product code 72627-2506. 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 Papeverine Hcl/phenoloamine Mesylate/prostaglandin E1?

The NDC package code 72627-2506-3 was assigned to a 5 mL in 1 VIAL, MULTI-DOSE of papaverine hydrochloride; phentolamine mesylate; alprostadil administered intracavernous via injection, powder, lyophilized, for solution.

Who manufactures this product?

Papeverine Hcl/phenoloamine Mesylate/prostaglandin E1 is manufactured by an outsourced facility and labeled by Empower Pharmacy. 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.