Diclofenac Sodium
NDC Package 60505-0399-5

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.

Diclofenac Sodium is diclofenac is used to relieve pain, swelling (inflammation), and joint stiffness caused by arthritis. Marketed by Apotex Corp., this product is identified by NDC 60505-0399 and is authorized under FDA application ANDA202027.

Identification & Billing

NDC Package Code
60505-0399-5
Package Description
1 BOTTLE in 1 CARTON / 150 mL in 1 BOTTLE
Product Code
60505-0399
11-Digit Billing Format
60505039905
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 311498 - menthol 10 % / methyl salicylate 15 % Topical Cream
  • RxCUI: 311498 - menthol 100 MG/ML / methyl salicylate 150 MG/ML Topical Cream
  • RxCUI: 311498 - menthol 10 GM / methyl salicylate 15 GM per 100 GM Topical Cream
  • RxCUI: 857700 - diclofenac sodium 1.5 % Topical Solution
  • RxCUI: 857700 - diclofenac sodium 15 MG/ML Topical Solution

Clinical Specifications

Proprietary Name
Diclofenac Sodium
Dosage Form
-
Usage Information
Diclofenac is used to relieve pain, swelling (inflammation), and joint stiffness caused by arthritis. Reducing these symptoms helps you do more of your normal daily activities. This medication is known as a nonsteroidal anti-inflammatory drug (NSAID). If you are treating a chronic condition such as arthritis, ask your doctor about non-drug treatments and/or using other medications to treat your pain. See also Warning section.

Regulatory & Marketing

Labeler Name
Apotex Corp.
FDA Application #
ANDA202027
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-28-2014
End Marketing Date
05-31-2021
Listing Expiration
05-31-2021
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 60505-0399-5 identifies a specific commercial package of 1 bottle in 1 carton / 150 ml in 1 bottle of Diclofenac Sodium, labeled by Apotex Corp.. 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 Apotex Corp. on May 28, 2014. The current certification is valid through May 31, 2021.

What are the primary indications for this medication?

Diclofenac is used to relieve pain, swelling (inflammation), and joint stiffness caused by arthritis. Reducing these symptoms helps you do more of your normal daily activities. This medication is known as a nonsteroidal anti-inflammatory drug (NSAID). If you are treating a chronic condition such as arthritis, ask your doctor about non-drug treatments and/or using other medications to treat your pain. See also Warning section.

How is this Apotex Corp. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 60505039905. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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 (5-4-1)
60505-0399-5
11-Digit CMS (5-4-2)
60505-0399-05

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