Raloxifene Hydrochloride
NDC Package 71335-1663-2

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 inactivated by the FDA.

Raloxifene Hydrochloride is tablets, USP are indicated for the treatment and prevention of osteoporosis in postmenopausal women [see Clinical Studies (14.1, 14.2)]. Marketed by Bryant Ranch Prepack, this product is identified by NDC 71335-1663 and is authorized under FDA application ANDA090842.

Identification & Billing

NDC Package Code
71335-1663-2
Package Description
30 TABLET in 1 BOTTLE
Product Code
71335-1663
11-Digit Billing Format
71335166302
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Raloxifene Hydrochloride
Dosage Form
-
Usage Information
Raloxifene hydrochloride tablets, USP are indicated for the treatment and prevention of osteoporosis in postmenopausal women [see Clinical Studies (14.1, 14.2)].

Regulatory & Marketing

Labeler Name
Bryant Ranch Prepack
FDA Application #
ANDA090842
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-29-2016
Listing Expiration
12-31-2023
Exclude Flag
I
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 (71335-1663). Click a package code to view its specific billing and regulatory data.

71335-1663-1
60 TABLET 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 71335-1663-2 identifies a specific commercial package of 30 tablet in 1 bottle of Raloxifene Hydrochloride, labeled by Bryant Ranch Prepack. 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 Bryant Ranch Prepack on June 29, 2016. The current certification is valid through December 31, 2023.

How is this Bryant Ranch Prepack product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71335166302. 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)
71335-1663-2
11-Digit CMS (5-4-2)
71335-1663-02

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