Diclofenac Sodium Tablet, Delayed Release
NDC Package 82804-315-30

11-digit billing NDC: 82804031530
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Diclofenac Sodium tablets is carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. This formulation utilizes a tablet, delayed release delivery system. Marketed by Proficient Rx Lp, this product is identified by NDC 82804-315 and is authorized under FDA application ANDA075281.

Identification & Billing

NDC Package Code
82804-315-30
Package Description
30 TABLET, DELAYED RELEASE in 1 BOTTLE
Product Code
82804-315
11-Digit Billing Format
82804031530

Clinical Specifications

Proprietary Name
Diclofenac Sodium
Non-Proprietary Name
Diclofenac Sodium
Substance Name
Diclofenac Sodium
Dosage Form
Tablet, Delayed Release - A solid dosage form which releases a drug (or drugs) at a time other than promptly after administration. Enteric-coated articles are delayed release dosage forms.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DICLOFENAC SODIUM 50 mg/1
Pharmacologic Class
Usage Information
Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation).Diclofenac sodium delayed-release tablets are indicated:•for relief of the signs and symptoms of osteoarthritis•for relief of the signs and symptoms of rheumatoid arthritis•for acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis

Regulatory & Marketing

Labeler Name
Proficient Rx Lp
Product Type
Human Prescription Drug
FDA Application #
ANDA075281
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-17-2025
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 82804-315-30 identifies a specific commercial package of 30 tablet, delayed release in 1 bottle of Diclofenac Sodium, a human prescription drug labeled by Proficient Rx Lp. This tablet, delayed release is formulated for oral 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 Proficient Rx Lp on April 17, 2025. The current certification is valid through December 31, 2027.

How is this Proficient Rx Lp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 82804031530. 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)
82804-315-30
11-Digit CMS (5-4-2)
82804-0315-30

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