Guaifenesin Extended Release
NDC Package 45802-325-66

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Guaifenesin Extended Release is a . Marketed by Padagis Israel Pharmaceuticals Ltd, this product is identified by NDC 45802-325 and is authorized under FDA application ANDA091009.

Identification & Billing

NDC Package Code
45802-325-66
Package Description
1 BOTTLE in 1 CARTON / 14 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code
45802-325
11-Digit Billing Format
45802032566
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA

Clinical Specifications

Proprietary Name
Guaifenesin Extended Release
Dosage Form
-

Regulatory & Marketing

Labeler Name
Padagis Israel Pharmaceuticals Ltd
FDA Application #
ANDA091009
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-25-2016
End Marketing Date
12-31-2021
Listing Expiration
12-31-2021
Exclude Flag
D
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (45802-325). Click a package code to view its specific billing and regulatory data.

45802-325-30
1 BOTTLE in 1 CARTON / 28 TABLET, EXTENDED RELEASE in 1 BOTTLE

* 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 45802-325-66 identifies a specific commercial package of 1 bottle in 1 carton / 14 tablet, extended release in 1 bottle of Guaifenesin Extended Release, labeled by Padagis Israel Pharmaceuticals Ltd. 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 Padagis Israel Pharmaceuticals Ltd on January 25, 2016. The current certification is valid through December 31, 2021.

How is this Padagis Israel Pharmaceuticals Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 45802032566. 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)
45802-325-66
11-Digit CMS (5-4-2)
45802-0325-66

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