Butalbital And Acetaminophen
NDC Package 79739-7075-1

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.

Butalbital And Acetaminophen is tablets are indicated for the relief of the symptom complex of tension (or muscle contraction) headache.Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Marketed by Lgm Pharma Solutions, Llc, this product is identified by NDC 79739-7075 and is authorized under FDA application ANDA090956.

Identification & Billing

NDC Package Code
79739-7075-1
Package Description
100 TABLET in 1 BOTTLE, PLASTIC
Product Code
79739-7075
11-Digit Billing Format
79739707501
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Butalbital And Acetaminophen
Dosage Form
-
Usage Information
Butalbital and Acetaminophen Tablets are indicated for the relief of the symptom complex of tension (or muscle contraction) headache.Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.

Regulatory & Marketing

Labeler Name
Lgm Pharma Solutions, Llc
FDA Application #
ANDA090956
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-23-2011
Listing Expiration
12-31-2021
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 79739-7075-1 identifies a specific commercial package of 100 tablet in 1 bottle, plastic of Butalbital And Acetaminophen, labeled by Lgm Pharma Solutions, 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 Lgm Pharma Solutions, Llc on August 23, 2011. The current certification is valid through December 31, 2021.

How is this Lgm Pharma Solutions, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 79739707501. 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 (5-4-1)
79739-7075-1
11-Digit CMS (5-4-2)
79739-7075-01

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