Diclovix M
NDC Package 72275-719-77

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.

Diclovix M is diclofenac sodium topical solution is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s). Marketed by Primary Pharmaceuticals, Inc, this product is identified by NDC 72275-719 and is authorized under FDA application ANDA202769.

Identification & Billing

NDC Package Code
72275-719-77
Package Description
1 KIT in 1 KIT * 150 mL in 1 BOTTLE (52565-002-05) * 85 g in 1 PACKET (53329-984-16)
Product Code
72275-719
11-Digit Billing Format
72275071977
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Diclovix M
Dosage Form
-
Usage Information
Diclofenac sodium topical solution is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s).

Regulatory & Marketing

Labeler Name
Primary Pharmaceuticals, Inc
FDA Application #
ANDA202769
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-09-2018
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 72275-719-77 identifies a specific commercial package of 1 kit in 1 kit * 150 ml in 1 bottle (52565-002-05) * 85 g in 1 packet (53329-984-16) of Diclovix M, labeled by Primary Pharmaceuticals, Inc. 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 Primary Pharmaceuticals, Inc on August 09, 2018. The current certification is valid through December 31, 2022.

How is this Primary Pharmaceuticals, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72275071977. 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)
72275-719-77
11-Digit CMS (5-4-2)
72275-0719-77

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