Zebutal
NDC Package 68308-554-10

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 discontinued by the firm.

Zebutal is this combination medication is used to treat tension headaches. Marketed by Mayne Pharma Inc., this product is identified by NDC 68308-554 and is authorized under FDA application ANDA089007.

Identification & Billing

NDC Package Code
68308-554-10
Package Description
100 CAPSULE in 1 BOTTLE, PLASTIC
Product Code
68308-554
11-Digit Billing Format
68308055410
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA

Clinical Specifications

Proprietary Name
Zebutal
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
Mayne Pharma Inc.
FDA Application #
ANDA089007
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-26-2013
End Marketing Date
10-31-2023
Listing Expiration
10-31-2023
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 68308-554-10 identifies a specific commercial package of 100 capsule in 1 bottle, plastic of Zebutal, labeled by Mayne Pharma 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 Mayne Pharma Inc. on December 26, 2013. The current certification is valid through October 31, 2023.

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 Mayne Pharma Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68308055410. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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)
68308-554-10
11-Digit CMS (5-4-2)
68308-0554-10

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