Vanatol
NDC Package 58809-820-16

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.

Vanatol is this combination medication is used to treat tension headaches. Marketed by Gm Pharmaceuticals, this product is identified by NDC 58809-820 and is authorized under FDA application ANDA040387.

Identification & Billing

NDC Package Code
58809-820-16
Package Description
473 mL in 1 BOTTLE, PLASTIC
Product Code
58809-820
11-Digit Billing Format
58809082016
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
473 ML

Clinical Specifications

Proprietary Name
Vanatol LQ
Dosage Form
-
Usage Information
This combination medication is used to treat tension headaches. Acetaminophen helps to decrease the pain from the headache. Caffeine helps increase the effects of acetaminophen. Butalbital is a sedative that helps to decrease anxiety and cause sleepiness and relaxation.

Regulatory & Marketing

Labeler Name
Gm Pharmaceuticals
FDA Application #
ANDA040387
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-28-2015
End Marketing Date
06-05-2020
Listing Expiration
06-05-2020
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 (58809-820). Click a package code to view its specific billing and regulatory data.

58809-820-02
30 mL in 1 BOTTLE, PLASTIC

* 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 58809-820-16 identifies a specific commercial package of 473 ml in 1 bottle, plastic of Vanatol LQ, labeled by Gm Pharmaceuticals. This product is billed per "ML" milliliter and contains an estimated amount of 473 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 Gm Pharmaceuticals on April 28, 2015. The current certification is valid through June 05, 2020.

What are the primary indications for this medication?

This combination medication is used to treat tension headaches. Acetaminophen helps to decrease the pain from the headache. Caffeine helps increase the effects of acetaminophen. Butalbital is a sedative that helps to decrease anxiety and cause sleepiness and relaxation.

How is this Gm Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58809082016. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 473 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)
58809-820-16
11-Digit CMS (5-4-2)
58809-0820-16

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