Risedronate Sodium
NDC Package 68382-075-73

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 EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Risedronate Sodium is risedronate is used to prevent and treat certain types of bone loss (osteoporosis) in adults. Marketed by Zydus Pharmaceuticals Usa Inc., this product is identified by NDC 68382-075 and is authorized under FDA application ANDA203822.

Identification & Billing

NDC Package Code
68382-075-73
Package Description
1 BLISTER PACK in 1 CARTON / 4 TABLET, DELAYED RELEASE in 1 BLISTER PACK
Product Code
68382-075
11-Digit Billing Format
68382007573

Clinical Specifications

Proprietary Name
Risedronate Sodium
Dosage Form
-
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
Zydus Pharmaceuticals Usa Inc.
FDA Application #
ANDA203822
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-10-2019
End Marketing Date
05-10-2025
Listing Expiration
05-10-2025
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 68382-075-73 identifies a specific commercial package of 1 blister pack in 1 carton / 4 tablet, delayed release in 1 blister pack of Risedronate Sodium, labeled by Zydus Pharmaceuticals Usa 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 Zydus Pharmaceuticals Usa Inc. on April 10, 2019. The current certification is valid through May 10, 2025.

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 Zydus Pharmaceuticals Usa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68382007573. 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)
68382-075-73
11-Digit CMS (5-4-2)
68382-0075-73

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