Risedronate Sodium Tablet, Delayed Release
NDC Package 63304-440-09

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. 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, delayed release delivery system. Marketed by Sun Pharmaceutical Industires Inc., this product is identified by NDC 63304-440 and is authorized under FDA application ANDA203925.

Identification & Billing

NDC Package Code
63304-440-09
Package Description
1 DOSE PACK in 1 CARTON / 4 TABLET, DELAYED RELEASE in 1 DOSE PACK (63304-440-11)
Product Code
63304-440
11-Digit Billing Format
63304044009
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk
  • RxCUI: 1020064 - risedronate sodium 35 MG Delayed Release Oral Tablet
  • RxCUI: 1020065 - {4 (risedronate sodium 35 MG Delayed Release Oral Tablet) } Pack
  • RxCUI: 1020065 - risedronate sodium 35 MG Delayed Release Oral Tablet 4 Count Pack

Clinical Specifications

Proprietary Name
Risedronate Sodium
Non-Proprietary Name
Risedronate Sodium
Substance Name
Risedronate Sodium
Dosage Form
Tablet, Delayed Release - A solid dosage form which releases a drug (or drugs) at a time other than promptly after administration. Enteric-coated articles are delayed release dosage forms.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
RISEDRONATE SODIUM 35 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
Sun Pharmaceutical Industires Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA203925
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-10-2019
Listing Expiration
12-31-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 63304-440-09 identifies a specific commercial package of 1 dose pack in 1 carton / 4 tablet, delayed release in 1 dose pack (63304-440-11) of Risedronate Sodium, a human prescription drug labeled by Sun Pharmaceutical Industires Inc.. This tablet, delayed release 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 Sun Pharmaceutical Industires Inc. on July 10, 2019. 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 Sun Pharmaceutical Industires Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63304044009. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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)
63304-440-09
11-Digit CMS (5-4-2)
63304-0440-09

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