Allzital
NDC Package 70538-450-01

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 discontinued by the firm.

Allzital is this combination medication is used to treat tension headaches. Marketed by Keswick Labs, Llc, this product is identified by NDC 70538-450 and is authorized under FDA application ANDA203484.

Identification & Billing

NDC Package Code
70538-450-01
Package Description
100 mg in 1 BOTTLE
Product Code
70538-450
11-Digit Billing Format
70538045001

Clinical Specifications

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

Regulatory & Marketing

Labeler Name
Keswick Labs, Llc
FDA Application #
ANDA203484
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-04-2015
End Marketing Date
03-13-2017
Listing Expiration
03-13-2017
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 70538-450-01 identifies a specific commercial package of 100 mg in 1 bottle of Allzital, labeled by Keswick Labs, Llc. 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 Keswick Labs, Llc on December 04, 2015. The current certification is valid through March 13, 2017.

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. Butalbital is a sedative that helps to decrease anxiety and cause sleepiness and relaxation.

How is this Keswick Labs, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70538045001. 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)
70538-450-01
11-Digit CMS (5-4-2)
70538-0450-01

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