Stendra
NDC Package 76299-321-85

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Stendra is avanafil is used to treat male sexual function problems (impotence or erectile dysfunction-ED). Marketed by Mist Pharmaceuticals, Llc, this product is identified by NDC 76299-321 and is authorized under FDA application NDA202276.

Identification & Billing

NDC Package Code
76299-321-85
Package Description
30 TABLET in 1 BOTTLE
Product Code
76299-321
11-Digit Billing Format
76299032185
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA

Clinical Specifications

Proprietary Name
Stendra
Dosage Form
-
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
Mist Pharmaceuticals, Llc
FDA Application #
NDA202276
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-27-2013
End Marketing Date
02-01-2023
Listing Expiration
02-01-2023
Exclude Flag
D
Sample Package
No

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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (76299-321). Click a package code to view its specific billing and regulatory data.

76299-321-88
100 TABLET in 1 BOTTLE
76299-321-96
6 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK (76299-321-01)

* 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 76299-321-85 identifies a specific commercial package of 30 tablet in 1 bottle of Stendra, labeled by Mist Pharmaceuticals, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Mist Pharmaceuticals, Llc on December 27, 2013. The current certification is valid through February 01, 2023.

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 Mist Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76299032185. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 total billable units per package. 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 (5-3-2)
76299-321-85
11-Digit CMS (5-4-2)
76299-0321-85

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