Risedronate Sodium Tablet, Film Coated
NDC Package 80426-042-01

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.

Risedronate Sodium tablets is risedronate is used to prevent and treat certain types of bone loss (osteoporosis) in adults. This formulation utilizes a tablet, film coated delivery system. Marketed by Pel Healthcare Llc, this product is identified by NDC 80426-042.

Identification & Billing

NDC Package Code
80426-042-01
Package Description
75000 TABLET, FILM COATED in 1 CONTAINER
Product Code
80426-042
11-Digit Billing Format
80426004201

Clinical Specifications

Proprietary Name
Risedronate Sodium
Non-Proprietary Name
Risedronate Sodium
Substance Name
Risedronate Sodium Monohydrate
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.
Active Ingredient(s)
RISEDRONATE SODIUM MONOHYDRATE 150 mg/1
Usage Information
Risedronate is used to prevent and treat certain types of bone loss (osteoporosis) in adults. Osteoporosis causes bones to become thinner and break more easily. Your chance of developing osteoporosis increases as you age, after menopause, or if you are taking corticosteroid medications (such as prednisone) for a long time. This medication works by slowing bone loss to help maintain strong bones and reduce the risk of broken bones (fractures). Risedronate belongs to a class of medications called bisphosphonates.

Regulatory & Marketing

Labeler Name
Pel Healthcare Llc
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
12-12-2016
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 80426-042-01 identifies a specific commercial package of 75000 tablet, film coated in 1 container of Risedronate Sodium (UNFINISHED drug), drug for further processing labeled by Pel Healthcare Llc. This tablet, film coated is formulated for use and contains risedronate sodium monohydrate 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 Pel Healthcare Llc on December 12, 2016. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Risedronate is used to prevent and treat certain types of bone loss (osteoporosis) in adults. Osteoporosis causes bones to become thinner and break more easily. Your chance of developing osteoporosis increases as you age, after menopause, or if you are taking corticosteroid medications (such as prednisone) for a long time. This medication works by slowing bone loss to help maintain strong bones and reduce the risk of broken bones (fractures). Risedronate belongs to a class of medications called bisphosphonates.

How is this Pel Healthcare Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 80426004201. 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)
80426-042-01
11-Digit CMS (5-4-2)
80426-0042-01

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