Diclofenac Sodium Gel
NDC Package 69238-2053-1

11-digit billing NDC: 69238205301 · Billing unit: GM · 100 GM per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Diclofenac Sodium (diclofenac) gel is use up to 21 days unless directed by your doctor.Not for strains, sprains, bruises or sports injuries. This formulation utilizes a gel delivery system. Marketed by Amneal Pharmaceuticals Ny Llc, this product is identified by NDC 69238-2053 and is authorized under FDA application ANDA208077.

Identification & Billing

NDC Package Code
69238-2053-1
Package Description
1 TUBE in 1 CARTON / 100 g in 1 TUBE
Product Code
69238-2053
11-Digit Billing Format
69238205301
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
100 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Diclofenac Sodium
Non-Proprietary Name
Diclofenac
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 doctor.Not for strains, sprains, bruises or sports injuries. This product has not been shown to work for these types of injuries.DailyPer DoseFor your arthritis pain:Use 4 times per day every dayDo not use on more than 2 body areasat the same timeUse ENCLOSED DOSING CARD to measure a doseFor 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 directeddo not use more than directed or for longer than directedapply only to clean, dry skin that does not have any cuts, open wounds, infections or rashesdo not apply in same areas as any other productdo not apply with external heat such as a heating paddo not apply a bandage over the treated areastore ENCLOSED DOSING CARD with your Diclofenac Sodium Topical Gel, 1%. The dosing card is re-usable.

Regulatory & Marketing

Labeler Name
Amneal Pharmaceuticals Ny Llc
Product Type
Human Otc Drug
FDA Application #
ANDA208077
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-21-2016
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 69238-2053-1 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 Amneal Pharmaceuticals Ny Llc. 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 Amneal Pharmaceuticals Ny Llc on March 21, 2016. The current certification is valid through December 31, 2027.

How is this Amneal Pharmaceuticals Ny Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69238205301. 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 (5-4-1)
69238-2053-1
11-Digit CMS (5-4-2)
69238-2053-01

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