Diclofenac Sodium Gel
NDC Package 53873-080-00

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Diclofenac Sodium gel is diclofenac is used to relieve pain, swelling (inflammation), and joint stiffness caused by arthritis. This formulation utilizes a gel delivery system. Marketed by Bora Pharmaceutical Services Inc., this product is identified by NDC 53873-080.

Identification & Billing

NDC Package Code
53873-080-00
Package Description
30 TUBE in 1 CASE / 50 g in 1 TUBE
Product Code
53873-080
11-Digit Billing Format
53873008000

Clinical Specifications

Proprietary Name
Diclofenac Sodium
Non-Proprietary Name
Diclofenac Sodium
Substance Name
Diclofenac Sodium
Dosage Form
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
Active Ingredient(s)
DICLOFENAC SODIUM 10 mg/g
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
Bora Pharmaceutical Services Inc.
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
05-19-2021
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 (53873-080). Click a package code to view its specific billing and regulatory data.

53873-080-01
36 TUBE in 1 CASE / 100 g in 1 TUBE
53873-080-02
30 TUBE in 1 CASE / 150 g in 1 TUBE

* 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 53873-080-00 identifies a specific commercial package of 30 tube in 1 case / 50 g in 1 tube of Diclofenac Sodium (UNFINISHED drug), drug for further processing labeled by Bora Pharmaceutical Services Inc.. This gel is formulated for use and contains diclofenac 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 Bora Pharmaceutical Services Inc. on May 19, 2021. The current certification is valid through December 31, 2026.

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 Bora Pharmaceutical Services Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53873008000. 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)
53873-080-00
11-Digit CMS (5-4-2)
53873-0080-00

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