Zostrix Original Strength
NDC Package 61787-442-02

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.

Zostrix Original Strength is •for persons under 18 years of age, ask a doctor before using•apply a thin film of cream and gently rub in until fully absorbed•for optimum relief, apply 3 to 4 times daily•best results typically occur after 2 to 4 weeks of continuous use•unless treating hands, wash hands thoroughly with soap and water immediately after use•see package insert for more information. Marketed by Akorn Consumer Health, this product is identified by NDC 61787-442 and is authorized under FDA application part348.

Identification & Billing

NDC Package Code
61787-442-02
Package Description
1 TUBE in 1 CARTON / 56.6 g in 1 TUBE
Product Code
61787-442
11-Digit Billing Format
61787044202
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
56.6 GM

Clinical Specifications

Proprietary Name
Zostrix Original Strength
Dosage Form
-
Usage Information
•for persons under 18 years of age, ask a doctor before using•apply a thin film of cream and gently rub in until fully absorbed•for optimum relief, apply 3 to 4 times daily•best results typically occur after 2 to 4 weeks of continuous use•unless treating hands, wash hands thoroughly with soap and water immediately after use•see package insert for more information

Regulatory & Marketing

Labeler Name
Akorn Consumer Health
FDA Application #
part348
Marketing Category
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date
01-09-2006
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 61787-442-02 identifies a specific commercial package of 1 tube in 1 carton / 56.6 g in 1 tube of Zostrix Original Strength, labeled by Akorn Consumer Health. This product is billed per "GM" gram and contains an estimated amount of 56.6 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 Akorn Consumer Health on January 09, 2006. The current certification is valid through December 31, 2022.

How is this Akorn Consumer Health product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61787044202. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 56.6 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)
61787-442-02
11-Digit CMS (5-4-2)
61787-0442-02

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