Varophen Kit
NDC Package 72835-201-02

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

Package Information

Varophen (diclofenac sodium and menthol, methyl salicylate) kits is diclofenac sodium topical solution is indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s) (1). This formulation utilizes a kit delivery system. Marketed by V2 Pharma, Llc, this product is identified by NDC 72835-201 and is authorized under FDA application ANDA202027.

Identification & Billing

NDC Package Code
72835-201-02
Package Description
1 KIT in 1 CARTON * 1 BOTTLE in 1 CARTON (60505-0399-5) / 150 mL in 1 BOTTLE * 1 TUBE in 1 CARTON (45802-174-53) / 85 g in 1 TUBE
Product Code
72835-201
11-Digit Billing Format
72835020102
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
RxNorm Crosswalk
  • RxCUI: 311498 - menthol 10 % / methyl salicylate 15 % Topical Cream
  • RxCUI: 311498 - menthol 100 MG/ML / methyl salicylate 150 MG/ML Topical Cream
  • RxCUI: 311498 - menthol 10 GM / methyl salicylate 15 GM per 100 GM Topical Cream
  • RxCUI: 857700 - diclofenac sodium 1.5 % Topical Solution
  • RxCUI: 857700 - diclofenac sodium 15 MG/ML Topical Solution

Clinical Specifications

Proprietary Name
Varophen
Non-Proprietary Name
Diclofenac Sodium And Menthol, Methyl Salicylate
Dosage Form
Kit - A packaged collection of related material.
Usage Information
Diclofenac sodium topical solution is indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s) (1).

Regulatory & Marketing

Labeler Name
V2 Pharma, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA202027
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-03-2019
Listing Expiration
12-31-2026
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 72835-201-02 identifies a specific commercial package of 1 kit in 1 carton * 1 bottle in 1 carton (60505-0399-5) / 150 ml in 1 bottle * 1 tube in 1 carton (45802-174-53) / 85 g in 1 tube of Varophen, a human prescription drug labeled by V2 Pharma, Llc. This kit is formulated for use and contains 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 V2 Pharma, Llc on June 03, 2019. The current certification is valid through December 31, 2026.

How is this V2 Pharma, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72835020102. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. 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)
72835-201-02
11-Digit CMS (5-4-2)
72835-0201-02

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