NDC Compounded Drug 73198-027-03 Phentolamine Mesylate; Papaverine Hydrochloride

Injection, Solution Intracavernous

Table of Contents

    1. Compounded Product Information
    2. NDC Crossover Products Matching Bimix Formula Bm3
    3. Frequently Asked Questions

Compounded Drug Product Information

NDC Product Code 73198-027
NDC Package Code 73198-027-03
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.		 73198002703
Package Description 2.5 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.		 Bimix Formula Bm3
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.		 Papaverine-30mg/phentolamine-3mg/ml
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.		 Phentolamine Mesylate; Papaverine Hydrochloride
Dosage Form Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
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 73198
Labeler Name What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		 Olympia Pharmacy
Substance Name Phentolamine Mesylate; Papaverine Hydrochloride
Active Ingredients Information 3 mg/1 mL; 30 mg/1 mL
Reporting Period 2022-2

NDC Crossover Products Matching Phentolamine Mesylate; Papaverine Hydrochloride

NDC crossover of Bimix Formula Bm3 with NDC 73198-027 a human compounded drug with other similar products matching the same substance name (Phentolamine Mesylate; Papaverine Hydrochloride) and the same administration route (intracavernous) or dosage form (injection, solution).

Frequently Asked Questions

What is the NDC number assigned to Bimix Formula Bm3?

Bimix Formula Bm3 was assigned by its manufacturer with NDC product code 73198-027. 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 Bimix Formula Bm3?

The NDC package code 73198-027-03 was assigned to a 2.5 mL in 1 VIAL, MULTI-DOSE of phentolamine mesylate; papaverine hydrochloride administered intracavernous via injection, solution.

Who manufactures this product?

Bimix Formula Bm3 is manufactured by an outsourced facility and labeled by Olympia 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.

Which are the NDC crossover matchings for this product?

We found 2 matching products that have the same substance, dosage form and administration route. The matching products are manufactured by Olympia Pharmacy with NDC product codes 73198-027-10 and 73198-027-10.