Raloxifene Hcl Powder
NDC Package 17337-0071-1

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.

Raloxifene Hcl powders is raloxifene is used by women to prevent and treat bone loss (osteoporosis) after menopause. This formulation utilizes a powder delivery system. Marketed by Olon S.p.a., this product is identified by NDC 17337-0071.

Identification & Billing

NDC Package Code
17337-0071-1
Package Description
1 BAG in 1 DRUM / 1 BAG in 1 BAG / 25 kg in 1 BAG
Product Code
17337-0071
11-Digit Billing Format
17337007101

Clinical Specifications

Proprietary Name
Raloxifene Hcl
Non-Proprietary Name
Raloxifene Hcl
Substance Name
Raloxifene Hydrochloride
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)
RALOXIFENE HYDROCHLORIDE 1 kg/kg
Usage Information
Raloxifene is used by women to prevent and treat bone loss (osteoporosis) after menopause. It slows down bone loss and helps to keep bones strong, making them less likely to break. Raloxifene may also lower the chance of getting a certain type of breast cancer (invasive breast cancer) after menopause. Raloxifene is not an estrogen hormone, but it acts like estrogen in some parts of the body, like your bones. In other parts of the body (uterus and breasts), raloxifene acts like an estrogen blocker. It does not relieve menopause symptoms such as hot flashes. Raloxifene belongs to a class of drugs known as selective estrogen receptor modulators-SERMs. This medication should not be used before menopause. It should not be used to prevent heart disease.

Regulatory & Marketing

Labeler Name
Olon S.p.a.
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
08-27-2019
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 17337-0071-1 identifies a specific commercial package of 1 bag in 1 drum / 1 bag in 1 bag / 25 kg in 1 bag of Raloxifene Hcl (UNFINISHED drug), a bulk ingredient labeled by Olon S.p.a.. This powder is formulated for use and contains raloxifene hydrochloride 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 Olon S.p.a. on August 27, 2019. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Raloxifene is used by women to prevent and treat bone loss (osteoporosis) after menopause. It slows down bone loss and helps to keep bones strong, making them less likely to break. Raloxifene may also lower the chance of getting a certain type of breast cancer (invasive breast cancer) after menopause. Raloxifene is not an estrogen hormone, but it acts like estrogen in some parts of the body, like your bones. In other parts of the body (uterus and breasts), raloxifene acts like an estrogen blocker. It does not relieve menopause symptoms such as hot flashes. Raloxifene belongs to a class of drugs known as selective estrogen receptor modulators-SERMs. This medication should not be used before menopause. It should not be used to prevent heart disease.

How is this Olon S.p.a. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 17337007101. 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)
17337-0071-1
11-Digit CMS (5-4-2)
17337-0071-01

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