Diclozor
NDC Package 69336-827-01

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.

Diclozor is diclofenac sodium topical gel, 1% is indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands.• Diclofenac sodium topical gel, 1% has not been evaluated for use on the spine, hip, or shoulder. Marketed by Sterling-knight Pharmaceuticals, Llc, this product is identified by NDC 69336-827 and is authorized under FDA application ANDA208077.

Identification & Billing

NDC Package Code
69336-827-01
Package Description
1 TUBE in 1 CARTON / 1 GEL in 1 TUBE
Product Code
69336-827
11-Digit Billing Format
69336082701
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Diclozor
Dosage Form
-
Usage Information
Diclofenac sodium topical gel, 1% is indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands.• Diclofenac sodium topical gel, 1% has not been evaluated for use on the spine, hip, or shoulder.

Regulatory & Marketing

Labeler Name
Sterling-knight Pharmaceuticals, Llc
FDA Application #
ANDA208077
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-04-2016
Listing Expiration
12-31-2018
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 69336-827-01 identifies a specific commercial package of 1 tube in 1 carton / 1 gel in 1 tube of Diclozor, labeled by Sterling-knight Pharmaceuticals, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 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 Sterling-knight Pharmaceuticals, Llc on October 04, 2016. The current certification is valid through December 31, 2018.

How is this Sterling-knight Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69336082701. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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 (5-3-2)
69336-827-01
11-Digit CMS (5-4-2)
69336-0827-01

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