Diclofenac Sodium
NDC Package 45865-436-60

11-digit billing NDC: 45865043660
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.

Diclofenac Sodium is carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Marketed by Medsource Pharmaceuticals, this product is identified by NDC 45865-436 and is authorized under FDA application ANDA074514.

Identification & Billing

NDC Package Code
45865-436-60
Package Description
60 TABLET, DELAYED RELEASE in 1 BOTTLE
Product Code
45865-436
11-Digit Billing Format
45865043660
RxNorm Crosswalk
RxCUI: 855906 - diclofenac sodium 50 MG Delayed Release Oral Tablet

Clinical Specifications

Proprietary Name
Diclofenac Sodium
Dosage Form
-
Usage Information
Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation) . Diclofenac sodium delayed-release tablets, USP are indicated:For relief of the signs and symptoms of osteoarthritisFor relief of the signs and symptoms of rheumatoid arthritisFor acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis

Regulatory & Marketing

Labeler Name
Medsource Pharmaceuticals
FDA Application #
ANDA074514
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-26-1996
Listing Expiration
12-31-2024
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 (45865-436). Click a package code to view its specific billing and regulatory data.

45865-436-30
30 TABLET, DELAYED RELEASE 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 45865-436-60 identifies a specific commercial package of 60 tablet, delayed release in 1 bottle of Diclofenac Sodium, labeled by Medsource Pharmaceuticals. 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 Medsource Pharmaceuticals on March 26, 1996. The current certification is valid through December 31, 2024.

How is this Medsource Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 45865043660. 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)
45865-436-60
11-Digit CMS (5-4-2)
45865-0436-60

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