Ospemifene Powder
NDC Package 50056-2021-5

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Ospemifene powders is a medication used to treat painful sexual intercourse and vaginal dryness in women after menopause. This formulation utilizes a powder delivery system. Marketed by Angelini Pharma Italia Aziende Chimiche Riunite Angelini Francesco A.c.r.a.f. Spa, this product is identified by NDC 50056-2021.

Identification & Billing

NDC Package Code
50056-2021-5
Package Description
50 kg in 1 DRUM
Product Code
50056-2021
11-Digit Billing Format
50056202105

Clinical Specifications

Proprietary Name
Ospemifene
Non-Proprietary Name
Ospemifene
Substance Name
Ospemifene
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
OSPEMIFENE 1 kg/kg
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
Angelini Pharma Italia Aziende Chimiche Riunite Angelini Francesco A.c.r.a.f. Spa
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING - A category specifying that a bulk product is intended for use on humans and requires a prescription.
Start Marketing Date
12-31-2021
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 50056-2021-5 identifies a specific commercial package of 50 kg in 1 drum of Ospemifene (UNFINISHED drug), a bulk ingredient labeled by Angelini Pharma Italia Aziende Chimiche Riunite Angelini Francesco A.c.r.a.f. Spa. This powder is formulated for use and contains ospemifene 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 Angelini Pharma Italia Aziende Chimiche Riunite Angelini Francesco A.c.r.a.f. Spa on December 31, 2021. The current certification is valid through December 31, 2026.

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 Angelini Pharma Italia Aziende Chimiche Riunite Angelini Francesco A.c.r.a.f. Spa product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50056202105. 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 (5-4-1)
50056-2021-5
11-Digit CMS (5-4-2)
50056-2021-05

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