Diclofenac Sodium
NDC Package 0168-0803-01

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 E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc., this product is identified by NDC 0168-0803 and is authorized under FDA application NDA021005.

Identification & Billing

NDC Package Code
0168-0803-01
Package Description
1 TUBE in 1 CARTON / 100 g in 1 TUBE
Product Code
0168-0803
11-Digit Billing Format
00168080301
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
100 GM

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
E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.
FDA Application #
NDA021005
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
05-06-2013
End Marketing Date
11-30-2016
Listing Expiration
11-30-2016
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 0168-0803-01 identifies a specific commercial package of 1 tube in 1 carton / 100 g in 1 tube of Diclofenac Sodium, labeled by E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.. 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 E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc. on May 06, 2013. The current certification is valid through November 30, 2016.

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 E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00168080301. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 100 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 (4-4-2)
0168-0803-01
11-Digit CMS (5-4-2)
00168-0803-01

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