Diclofenac Sodium D/r
NDC Package 61919-075-90

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

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Diclofenac Sodium D/r is iNDICATIONS AND USAGECarefully consider the potential bene ts and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac. Marketed by Direct_rx, this product is identified by NDC 61919-075 and is authorized under FDA application ANDA075185.

Identification & Billing

NDC Package Code
61919-075-90
Package Description
90 TABLET, DELAYED RELEASE in 1 BOTTLE
Product Code
61919-075
11-Digit Billing Format
61919007590
RxNorm Crosswalk
  • RxCUI: 855906 - diclofenac sodium 50 MG Delayed Release Oral Tablet
  • RxCUI: 855926 - diclofenac sodium 75 MG Delayed Release Oral Tablet

Clinical Specifications

Proprietary Name
Diclofenac Sodium D/r
Dosage Form
-
Usage Information
INDICATIONS AND USAGECarefully consider the potential bene ts and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).Diclofenac is 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
Direct_rx
FDA Application #
ANDA075185
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-16-2019
Listing Expiration
12-31-2020
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 (61919-075). Click a package code to view its specific billing and regulatory data.

61919-075-20
20 TABLET, DELAYED RELEASE in 1 BOTTLE
61919-075-30
30 TABLET, DELAYED RELEASE in 1 BOTTLE
61919-075-60
60 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 61919-075-90 identifies a specific commercial package of 90 tablet, delayed release in 1 bottle of Diclofenac Sodium D/r, labeled by Direct_rx. 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 Direct_rx on August 16, 2019. The current certification is valid through December 31, 2020.

How is this Direct_rx product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61919007590. 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)
61919-075-90
11-Digit CMS (5-4-2)
61919-0075-90

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