Diclotral Pak
NDC Package 69329-510-01

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.

Diclotral Pak 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 Patchwerx Labs, Inc., this product is identified by NDC 69329-510 and is authorized under FDA application ANDA202027.

Identification & Billing

NDC Package Code
69329-510-01
Package Description
1 KIT in 1 CARTON * 1 CARTON in 1 KIT / 1 BOTTLE in 1 CARTON (60505-0399-5) / 150 mL in 1 BOTTLE * 1 TUBE in 1 KIT / 127 mL in 1 TUBE (69329-323-01)
Product Code
69329-510
11-Digit Billing Format
69329051001
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Diclotral Pak
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
Patchwerx Labs, Inc.
FDA Application #
ANDA202027
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-28-2014
Listing Expiration
12-31-2017
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 69329-510-01 identifies a specific commercial package of 1 kit in 1 carton * 1 carton in 1 kit / 1 bottle in 1 carton (60505-0399-5) / 150 ml in 1 bottle * 1 tube in 1 kit / 127 ml in 1 tube (69329-323-01) of Diclotral Pak, labeled by Patchwerx Labs, 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 Patchwerx Labs, Inc. on May 28, 2014. The current certification is valid through December 31, 2017.

How is this Patchwerx Labs, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69329051001. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
69329-510-01
11-Digit CMS (5-4-2)
69329-0510-01

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