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  5. NDC Package Code: 50261-313-01 Annovera

NDC Package 50261-313-01 Annovera

Segesterone Acetate And Ethinyl Estradiol Ring Vaginal - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. 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:
50261-313-01
Package Description:
1 POUCH in 1 CARTON / 1 RING in 1 POUCH
Product Code:
50261-313
Proprietary Name:
Annovera
Non-Proprietary Name:
Segesterone Acetate And Ethinyl Estradiol
Substance Name:
Ethinyl Estradiol; Segesterone Acetate
Usage Information:
ANNOVERA is indicated for use by females of reproductive potential to prevent pregnancy.
11-Digit NDC Billing Format:
50261031301
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 2055983 - segesterone acetate 0.15 MG / ethinyl estradiol 0.013 MG per 24HR One Year Vaginal System
  • RxCUI: 2055983 - 273 DAY ethinyl estradiol 0.000542 MG/HR / segesterone acetate 0.00625 MG/HR Vaginal System
  • RxCUI: 2055983 - ethinyl estradiol 0.013 MG / segesterone acetate 0.15 MG per 24HR 273 Day Vaginal System
  • RxCUI: 2055989 - Annovera 0.15 MG / 0.013 MG per 24HR One Year Vaginal System
  • RxCUI: 2055989 - 273 DAY ethinyl estradiol 0.000542 MG/HR / segesterone acetate 0.00625 MG/HR Vaginal System [Annovera]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Therapeuticsmd, Inc.
    Dosage Form:
    Ring - A small circular object with a vacant circular center that is usually intended to be placed in the body by special inserters, where the medication is released, generally for localized effects.
    Administration Route(s):
  • Vaginal - Administration into the vagina.
    • Active Ingredient(s):
  • ETHINYL ESTRADIOL 17.4 mg/1
  • SEGESTERONE ACETATE 103 mg/1
    • Pharmacologic Class(es):
  • Estrogen Receptor Agonists - [MoA] (Mechanism of Action)
  • Estrogen - [EPC] (Established Pharmacologic Class)
  • Progesterone Congeners - [CS]
  • Progestin - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    NDA209627
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    08-12-2019
    Listing Expiration Date:
    12-31-2024
    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.

    Frequently Asked Questions

    What is NDC 50261-313-01?

    The NDC Packaged Code 50261-313-01 is assigned to a package of 1 pouch in 1 carton / 1 ring in 1 pouch of Annovera, a human prescription drug labeled by Therapeuticsmd, Inc.. The product's dosage form is ring and is administered via vaginal form.

    Is NDC 50261-313 included in the NDC Directory?

    Yes, Annovera with product code 50261-313 is active and included in the NDC Directory. The product was first marketed by Therapeuticsmd, Inc. on August 12, 2019 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 50261-313-01?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 1.

    What is the 11-digit format for NDC 50261-313-01?

    The 11-digit format is 50261031301. 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
    5-3-250261-313-015-4-250261-0313-01