Osphena
NDC Package 59630-580-55

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 discontinued by the firm.

Osphena is a medication used to treat painful sexual intercourse and vaginal dryness in women after menopause. Marketed by Shionogi Inc., this product is identified by NDC 59630-580 and is authorized under FDA application NDA203505.

Identification & Billing

NDC Package Code
59630-580-55
Package Description
1 BLISTER PACK in 1 PACKAGE / 5 TABLET, FILM COATED in 1 BLISTER PACK
Product Code
59630-580
11-Digit Billing Format
59630058055

Clinical Specifications

Proprietary Name
Osphena
Dosage Form
-
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).

Regulatory & Marketing

Labeler Name
Shionogi Inc.
FDA Application #
NDA203505
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-26-2013
End Marketing Date
07-31-2025
Listing Expiration
07-31-2025
Exclude Flag
D
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 (59630-580). Click a package code to view its specific billing and regulatory data.

59630-580-18
1 BLISTER PACK in 1 PACKAGE / 15 TABLET, FILM COATED in 1 BLISTER PACK
59630-580-90
90 TABLET, FILM COATED in 1 BOTTLE

* 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 59630-580-55 identifies a specific commercial package of 1 blister pack in 1 package / 5 tablet, film coated in 1 blister pack of Osphena, labeled by Shionogi Inc.. 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 Shionogi Inc. on February 26, 2013. The current certification is valid through July 31, 2025.

What are the primary indications for this medication?

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).

How is this Shionogi Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59630058055. 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)
59630-580-55
11-Digit CMS (5-4-2)
59630-0580-55

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