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  5. NDC Package Code: 50261-110-02 Imvexxy

NDC Package 50261-110-02 Imvexxy

Estradiol Insert Vaginal - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
50261-110-02
Package Description:
1 BLISTER PACK in 1 CARTON / 2 INSERT in 1 BLISTER PACK
Product Code:
50261-110
Proprietary Name:
Imvexxy
Non-Proprietary Name:
Estradiol
Substance Name:
Estradiol
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.
11-Digit NDC Billing Format:
50261011002
NDC to RxNorm Crosswalk:
  • RxCUI: 2048916 - Imvexxy 10 MCG Vaginal Insert
  • RxCUI: 2048916 - estradiol 0.01 MG Vaginal Insert [Imvexxy]
  • RxCUI: 2048916 - Imvexxy 0.01 MG Vaginal Insert
  • RxCUI: 2048917 - estradiol 4 MCG Vaginal Insert
  • RxCUI: 2048917 - estradiol 0.004 MG Vaginal Insert
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Mayne Pharma Llc
    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(s):
  • Vaginal - Administration into the vagina.
    • Active Ingredient(s):
  • ESTRADIOL 10 ug/1
    • Pharmacologic Class(es):
  • Estradiol Congeners - [CS]
  • Estrogen Receptor Agonists - [MoA] (Mechanism of Action)
  • Estrogen - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    Yes
    FDA Application Number:
    NDA208564
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    07-03-2018
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    50261-110-081 BLISTER PACK in 1 CARTON / 8 INSERT in 1 BLISTER PACK
    50261-110-181 BLISTER PACK in 1 CARTON / 18 INSERT in 1 BLISTER PACK

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 50261-110-02?

    The NDC Packaged Code 50261-110-02 is assigned to a package of 1 blister pack in 1 carton / 2 insert in 1 blister pack of Imvexxy, a human prescription drug labeled by Mayne Pharma Llc. The product's dosage form is insert and is administered via vaginal form.

    Is NDC 50261-110 included in the NDC Directory?

    Yes, Imvexxy with product code 50261-110 is active and included in the NDC Directory. The product was first marketed by Mayne Pharma Llc on July 03, 2018 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 50261-110-02?

    The 11-digit format is 50261011002. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-250261-110-025-4-250261-0110-02