Risedronate Sodium Tablet, Film Coated
NDC Package 33342-107-06

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

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 Macleods Pharmaceuticals Limited, this product is identified by NDC 33342-107 and is authorized under FDA application ANDA203533.

Identification & Billing

NDC Package Code
33342-107-06
Package Description
3 BLISTER PACK in 1 CARTON / 10 TABLET, FILM COATED in 1 BLISTER PACK
Product Code
33342-107
11-Digit Billing Format
33342010706
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Risedronate Sodium
Non-Proprietary Name
Risedronate Sodium
Substance Name
Risedronate Sodium
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.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
RISEDRONATE SODIUM 5 mg/1
Pharmacologic Class
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
Macleods Pharmaceuticals Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA203533
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-09-2015
Listing Expiration
12-31-2027
Exclude Flag
N
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 (33342-107). Click a package code to view its specific billing and regulatory data.

33342-107-07
30 TABLET, FILM COATED in 1 CONTAINER
33342-107-49
2000 TABLET, FILM COATED in 1 CONTAINER

* 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 33342-107-06 identifies a specific commercial package of 3 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack of Risedronate Sodium, a human prescription drug labeled by Macleods Pharmaceuticals Limited. This tablet, film coated is formulated for oral use and contains risedronate sodium 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 Macleods Pharmaceuticals Limited on December 09, 2015. The current certification is valid through December 31, 2027.

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 Macleods Pharmaceuticals Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 33342010706. 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)
33342-107-06
11-Digit CMS (5-4-2)
33342-0107-06

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