Diclofenac Sodium Solution
NDC Package 21922-033-16

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Diclofenac Sodium (diclofenac) solution is diclofenac is used to relieve pain, swelling (inflammation), and joint stiffness caused by arthritis. This formulation utilizes a solution delivery system. Marketed by Encube Ethicals, Inc., this product is identified by NDC 21922-033 and is authorized under FDA application ANDA217646.

Identification & Billing

NDC Package Code
21922-033-16
Package Description
1 BOTTLE, PUMP in 1 CARTON / 112 g in 1 BOTTLE, PUMP
Product Code
21922-033
11-Digit Billing Format
21922003316
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
112 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Diclofenac Sodium
Non-Proprietary Name
Diclofenac
Substance Name
Diclofenac Sodium
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
DICLOFENAC SODIUM 20 mg/g
Pharmacologic Class
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
Encube Ethicals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA217646
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-14-2025
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 21922-033-16 identifies a specific commercial package of 1 bottle, pump in 1 carton / 112 g in 1 bottle, pump of Diclofenac Sodium, a human prescription drug labeled by Encube Ethicals, Inc.. This solution is formulated for topical 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 Encube Ethicals, Inc. on April 14, 2025. 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 Encube Ethicals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 21922003316. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 112 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 (5-3-2)
21922-033-16
11-Digit CMS (5-4-2)
21922-0033-16

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