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  5. NDC Package Code: 55494-580-18 Osphena

NDC Package 55494-580-18 Osphena

Ospemifene Tablet, Film Coated Oral - 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:
55494-580-18
Package Description:
1 BLISTER PACK in 1 PACKAGE / 15 TABLET, FILM COATED in 1 BLISTER PACK
Product Code:
55494-580
Proprietary Name:
Osphena
Non-Proprietary Name:
Ospemifene
Substance Name:
Ospemifene
Usage Information:
This medication is used to treat painful sexual intercourse and vaginal dryness in women after menopause. Painful intercourse and vaginal dryness are symptoms of changes in and around your vagina, due to menopause. This drug is different from hormones (including estrogens and progestins). It works by acting like estrogen in some parts of the body. Ospemifene belongs to a class of drugs known as selective estrogen receptor modulators (SERM).
11-Digit NDC Billing Format:
55494058018
NDC to RxNorm Crosswalk:
  • RxCUI: 1370976 - ospemifene 60 MG Oral Tablet
  • RxCUI: 1370982 - Osphena 60 MG Oral Tablet
  • RxCUI: 1370982 - ospemifene 60 MG Oral Tablet [Osphena]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Duchesnay Usa, Inc.
    Dosage Form:
    Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • OSPEMIFENE 60 mg/1
    • Pharmacologic Class(es):
  • Estrogen Agonist/Antagonist - [EPC] (Established Pharmacologic Class)
  • Selective Estrogen Receptor Modulators - [MoA] (Mechanism of Action)
    • Sample Package:
    Yes
    FDA Application Number:
    NDA203505
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    04-01-2023
    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
    55494-580-3030 TABLET, FILM COATED in 1 BOTTLE
    55494-580-551 BLISTER PACK in 1 PACKAGE / 5 TABLET, FILM COATED in 1 BLISTER PACK
    55494-580-9090 TABLET, FILM COATED in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 55494-580-18?

    The NDC Packaged Code 55494-580-18 is assigned to a package of 1 blister pack in 1 package / 15 tablet, film coated in 1 blister pack of Osphena, a human prescription drug labeled by Duchesnay Usa, Inc.. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 55494-580 included in the NDC Directory?

    Yes, Osphena with product code 55494-580 is active and included in the NDC Directory. The product was first marketed by Duchesnay Usa, Inc. on April 01, 2023 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 55494-580-18?

    The 11-digit format is 55494058018. 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
    5-3-255494-580-185-4-255494-0580-18