Imvexxy
NDC Package 50261-104-02

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 inactivated by the FDA.

Imvexxy is a medication a female hormone (estrogen). Marketed by Mayne Pharma Llc, this product is identified by NDC 50261-104 and is authorized under FDA application NDA208564.

Identification & Billing

NDC Package Code
50261-104-02
Package Description
1 BLISTER PACK in 1 CARTON / 2 INSERT in 1 BLISTER PACK
Product Code
50261-104
11-Digit Billing Format
50261010402
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Imvexxy
Dosage Form
-
Usage Information
This medication is a female hormone (estrogen). It is used by women to help reduce vaginal symptoms of menopause (such as vaginal dryness/burning/itching). These symptoms are caused by the body making less estrogen. When treating only vaginal symptoms of menopause, products applied directly inside the vagina (such as this medication) should be used first. Estrogens that are taken by mouth, absorbed through the skin, or injected may have greater risks of side effects due to more estrogen being absorbed.

Regulatory & Marketing

Labeler Name
Mayne Pharma Llc
FDA Application #
NDA208564
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-05-2018
Listing Expiration
12-31-2026
Exclude Flag
I
Sample Package
Yes

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 (50261-104). Click a package code to view its specific billing and regulatory data.

50261-104-08
1 BLISTER PACK in 1 CARTON / 8 INSERT in 1 BLISTER PACK
50261-104-18
1 BLISTER PACK in 1 CARTON / 18 INSERT in 1 BLISTER PACK

* 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 50261-104-02 identifies a specific commercial package of 1 blister pack in 1 carton / 2 insert in 1 blister pack of Imvexxy, labeled by Mayne Pharma Llc. 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 Mayne Pharma Llc on July 05, 2018. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is a female hormone (estrogen). It is used by women to help reduce vaginal symptoms of menopause (such as vaginal dryness/burning/itching). These symptoms are caused by the body making less estrogen. When treating only vaginal symptoms of menopause, products applied directly inside the vagina (such as this medication) should be used first. Estrogens that are taken by mouth, absorbed through the skin, or injected may have greater risks of side effects due to more estrogen being absorbed.

How is this Mayne Pharma Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50261010402. 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)
50261-104-02
11-Digit CMS (5-4-2)
50261-0104-02

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