Diclofenac Sodium Gel
NDC Package 68788-4335-1

11-digit billing NDC: 68788433501
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Diclofenac Sodium gel is use up to 21 days unless directed by your doctorNot for strains, sprains, bruises or sports injuries. This formulation utilizes a gel delivery system. Marketed by Preferred Pharmaceuticals Inc., this product is identified by NDC 68788-4335 and is authorized under FDA application ANDA204306.

Identification & Billing

NDC Package Code
68788-4335-1
Package Description
1 TUBE in 1 CARTON / 100 g in 1 TUBE
Product Code
68788-4335
11-Digit Billing Format
68788433501
RxNorm Crosswalk

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.
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 10 mg/g
Pharmacologic Class
Usage Information
Use up to 21 days unless directed by your doctorNot for strains, sprains, bruises or sports injuries. This product has not been shown to work for these types of injuries.                                 Daily                             Per DoseFor your arthritis pain:•Use 4 times per day every day•Do not use on more than 2 body areas at the same timeUse ENCLOSED DOSING CARD to measure a dose•For each upper body area (hand, wrist, or elbow) - Squeeze out 2.25 inches (2 grams)•For each lower body area (foot, ankle or knee) - Squeeze out 4.5 inches (4 grams)Read the enclosed User Guide for complete instructions:•use only as directed•do not use more than directed or for longer than directed•apply only to clean, dry skin that does not have any cuts, open wounds, infections or rashes•do not apply in same area as any other product•do not apply with external heat such as heating pad•do not apply a bandage over the treated area•store ENCLOSED DOSING CARD with your diclofenac sodium topical gel arthritis pain. The dosing card is re-usable.

Regulatory & Marketing

Labeler Name
Preferred Pharmaceuticals Inc.
Product Type
Human Otc Drug
FDA Application #
ANDA204306
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-02-2026
Listing Expiration
12-31-2027
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 68788-4335-1 identifies a specific commercial package of 1 tube in 1 carton / 100 g in 1 tube of Diclofenac Sodium, a human over the counter drug labeled by Preferred Pharmaceuticals Inc.. This gel 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 Preferred Pharmaceuticals Inc. on July 02, 2026. The current certification is valid through December 31, 2027.

How is this Preferred Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68788433501. 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)
68788-4335-1
11-Digit CMS (5-4-2)
68788-4335-01

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