Avanafil Tablet
NDC Package 53360-1141-0

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Avanafil tablets is avanafil is used to treat male sexual function problems (impotence or erectile dysfunction-ED). This formulation utilizes a tablet delivery system. Marketed by Sanofi Winthrop Industrie, this product is identified by NDC 53360-1141.

Identification & Billing

NDC Package Code
53360-1141-0
Package Description
1 BAG in 1 DRUM / 90000 TABLET in 1 BAG
Product Code
53360-1141
11-Digit Billing Format
53360114100

Clinical Specifications

Proprietary Name
Avanafil
Non-Proprietary Name
Avanafil
Substance Name
Avanafil
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Active Ingredient(s)
AVANAFIL 50 mg/1
Usage Information
Avanafil is used to treat male sexual function problems (impotence or erectile dysfunction-ED). In combination with sexual stimulation, avanafil works by increasing blood flow to the penis to help a man get and keep an erection. This drug does not protect against sexually transmitted diseases (such as HIV, hepatitis B, gonorrhea, syphilis). To decrease your risk of infection, always use an effective barrier method (latex or polyurethane condom/dental dams) during all sexual activity. Consult your doctor or pharmacist for more details.

Regulatory & Marketing

Labeler Name
Sanofi Winthrop Industrie
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
12-27-2013
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 53360-1141-0 identifies a specific commercial package of 1 bag in 1 drum / 90000 tablet in 1 bag of Avanafil (UNFINISHED drug), drug for further processing labeled by Sanofi Winthrop Industrie. This tablet is formulated for use and contains avanafil as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Sanofi Winthrop Industrie on December 27, 2013. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Avanafil is used to treat male sexual function problems (impotence or erectile dysfunction-ED). In combination with sexual stimulation, avanafil works by increasing blood flow to the penis to help a man get and keep an erection. This drug does not protect against sexually transmitted diseases (such as HIV, hepatitis B, gonorrhea, syphilis). To decrease your risk of infection, always use an effective barrier method (latex or polyurethane condom/dental dams) during all sexual activity. Consult your doctor or pharmacist for more details.

How is this Sanofi Winthrop Industrie product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53360114100. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-4-1)
53360-1141-0
11-Digit CMS (5-4-2)
53360-1141-00

Note: The zero is added to the Package segment to maintain the 5-4-2 structure.