Diclofenac Potassium Powder, For Solution
NDC Package 75834-338-01

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

Diclofenac Potassium powders is diclofenac is used to relieve pain and swelling (inflammation) from various mild to moderate painful conditions. This formulation utilizes a powder, for solution delivery system. Marketed by Nivagen Pharmaceuticals, Inc., this product is identified by NDC 75834-338 and is authorized under FDA application ANDA217010.

Identification & Billing

NDC Package Code
75834-338-01
Package Description
1 POWDER, FOR SOLUTION in 1 PACKET
Product Code
75834-338
11-Digit Billing Format
75834033801
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Diclofenac Potassium
Non-Proprietary Name
Diclofenac Potassium
Substance Name
Diclofenac Potassium
Dosage Form
Powder, For Solution - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a solution.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DICLOFENAC POTASSIUM 50 mg/1
Pharmacologic Class
Usage Information
Diclofenac is used to relieve pain and swelling (inflammation) from various mild to moderate painful conditions. It is used to treat muscle aches, backaches, dental pain, menstrual cramps, and sports injuries. It also reduces pain, swelling, 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
Nivagen Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA217010
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-15-2025
Listing Expiration
12-31-2026
Exclude Flag
N
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 (75834-338). Click a package code to view its specific billing and regulatory data.

75834-338-02
9 POWDER, FOR SOLUTION in 1 CARTON

* 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 75834-338-01 identifies a specific commercial package of 1 powder, for solution in 1 packet of Diclofenac Potassium, a human prescription drug labeled by Nivagen Pharmaceuticals, Inc.. This powder, for solution is formulated for oral 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 Nivagen Pharmaceuticals, Inc. on December 15, 2025. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Diclofenac is used to relieve pain and swelling (inflammation) from various mild to moderate painful conditions. It is used to treat muscle aches, backaches, dental pain, menstrual cramps, and sports injuries. It also reduces pain, swelling, 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 Nivagen Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 75834033801. 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)
75834-338-01
11-Digit CMS (5-4-2)
75834-0338-01

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