Diclofenac Sodium 1.5%
NDC Package 50436-2225-1

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 1.5% is diclofenac sodium topical solution is contraindicated in patients with a known hypersensitivity to diclofenac sodium or any other component of diclofenac sodium topical solution.Diclofenac sodium topical solution is contraindicated in patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Marketed by Unit Dose Services, this product is identified by NDC 50436-2225 and is authorized under FDA application ANDA202769.

Identification & Billing

NDC Package Code
50436-2225-1
Package Description
150 mL in 1 BOTTLE
Product Code
50436-2225
11-Digit Billing Format
50436222501
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
150 ML
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 1.5%
Dosage Form
-
Usage Information
Diclofenac sodium topical solution is contraindicated in patients with a known hypersensitivity to diclofenac sodium or any other component of diclofenac sodium topical solution.Diclofenac sodium topical solution is contraindicated in patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients [see Warnings and Precautions (5.7, 5.10)].Diclofenac sodium topical solution is contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see Warnings and Precautions (5.1)].

Regulatory & Marketing

Labeler Name
Unit Dose Services
FDA Application #
ANDA202769
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-20-2017
Listing Expiration
12-31-2022
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 50436-2225-1 identifies a specific commercial package of 150 ml in 1 bottle of Diclofenac Sodium 1.5%, labeled by Unit Dose Services. This product is billed per "ML" milliliter and contains an estimated amount of 150 billable units per package. 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 Unit Dose Services on November 20, 2017. The current certification is valid through December 31, 2022.

How is this Unit Dose Services product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50436222501. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 150 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)
50436-2225-1
11-Digit CMS (5-4-2)
50436-2225-01

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