Diclofenac Potassium Powder
NDC Package 48589-0004-0

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 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 Potassium powders is diclofenac is used to relieve pain from various conditions. This formulation utilizes a powder delivery system. Marketed by Unique Chemicals, this product is identified by NDC 48589-0004.

Identification & Billing

NDC Package Code
48589-0004-0
Package Description
50 kg in 1 DRUM
Product Code
48589-0004
11-Digit Billing Format
48589000400

Clinical Specifications

Proprietary Name
Diclofenac Potassium
Non-Proprietary Name
Diclofenac Potassium
Substance Name
Diclofenac Potassium
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
DICLOFENAC POTASSIUM 1 kg/kg
Usage Information
Diclofenac is used to relieve pain from various conditions. This form of diclofenac is used to treat migraine headaches. Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking your body's production of certain natural substances that cause inflammation. This effect helps to decrease swelling, pain, or fever.

Regulatory & Marketing

Labeler Name
Unique Chemicals
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
11-04-2009
Listing Expiration
12-31-2027
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 48589-0004-0 identifies a specific commercial package of 50 kg in 1 drum of Diclofenac Potassium (UNFINISHED drug), a bulk ingredient labeled by Unique Chemicals. This powder is formulated for use and contains diclofenac potassium 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 Unique Chemicals on November 04, 2009. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Diclofenac is used to relieve pain from various conditions. This form of diclofenac is used to treat migraine headaches. Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking your body's production of certain natural substances that cause inflammation. This effect helps to decrease swelling, pain, or fever.

How is this Unique Chemicals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 48589000400. 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)
48589-0004-0
11-Digit CMS (5-4-2)
48589-0004-00

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