Diclofenac Sodium Topical Solution
NDC Package 45865-983-01

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Diclofenac Sodium Topical Solution is 1.5% w/w is indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s) (1). Marketed by Medsource Pharmaceuticals, this product is identified by NDC 45865-983 and is authorized under FDA application ANDA206715.

Identification & Billing

NDC Package Code
45865-983-01
Package Description
1 BOTTLE, DROPPER in 1 CARTON / 150 mL in 1 BOTTLE, DROPPER
Product Code
45865-983
11-Digit Billing Format
45865098301
RxNorm Crosswalk
  • RxCUI: 857700 - diclofenac sodium 1.5 % Topical Solution
  • RxCUI: 857700 - diclofenac sodium 15 MG/ML Topical Solution
  • RxCUI: 857700 - diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical Solution
  • RxCUI: 857700 - diclofenac sodium 16.05 MG per 1 ML Topical Solution

Clinical Specifications

Proprietary Name
Diclofenac Sodium Topical Solution
Dosage Form
-
Usage Information
Diclofenac Sodium topical solution, 1.5% w/w is indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s) (1).

Regulatory & Marketing

Labeler Name
Medsource Pharmaceuticals
FDA Application #
ANDA206715
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-01-2017
Listing Expiration
12-31-2024
Exclude Flag
I
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 45865-983-01 identifies a specific commercial package of 1 bottle, dropper in 1 carton / 150 ml in 1 bottle, dropper of Diclofenac Sodium Topical Solution, labeled by Medsource Pharmaceuticals. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Medsource Pharmaceuticals on November 01, 2017. The current certification is valid through December 31, 2024.

How is this Medsource Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 45865098301. 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)
45865-983-01
11-Digit CMS (5-4-2)
45865-0983-01

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