Imvexxy Insert
NDC Package 68308-747-00

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

Imvexxy (estradiol) inserts is a medication a female hormone (estrogen). This formulation utilizes a insert delivery system. Marketed by Mayne Pharma, this product is identified by NDC 68308-747 and is authorized under FDA application NDA208564.

Identification & Billing

NDC Package Code
68308-747-00
Package Description
1 BLISTER PACK in 1 CARTON / 2 INSERT in 1 BLISTER PACK
Product Code
68308-747
11-Digit Billing Format
68308074700
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Imvexxy
Non-Proprietary Name
Estradiol
Substance Name
Estradiol
Dosage Form
Insert - A specially formulated and shaped non-encapsulated solid preparation intended to be placed into a non-rectal orifice of the body, where drug is released, generally for localized effects.
Administration Route
Vaginal - Administration into the vagina.
Active Ingredient(s)
ESTRADIOL 4 ug/1
Pharmacologic Class
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
Product Type
Human Prescription Drug
FDA Application #
NDA208564
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-03-2024
Listing Expiration
12-31-2026
Exclude Flag
N
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 (68308-747). Click a package code to view its specific billing and regulatory data.

68308-747-08
1 BLISTER PACK in 1 CARTON / 8 INSERT in 1 BLISTER PACK
68308-747-18
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 68308-747-00 identifies a specific commercial package of 1 blister pack in 1 carton / 2 insert in 1 blister pack of Imvexxy, a human prescription drug labeled by Mayne Pharma. This insert is formulated for vaginal use and contains estradiol 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 Mayne Pharma on May 03, 2024. 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 product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68308074700. 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)
68308-747-00
11-Digit CMS (5-4-2)
68308-0747-00

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