Butalbital, Acetaminophen, Caffeine
NDC Package 68071-2365-9

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 inactivated by the FDA.

Butalbital, Acetaminophen, Caffeine is butalbital, acetaminophen and caffeine 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 Nucare Pharmaceuticals,inc., this product is identified by NDC 68071-2365 and is authorized under FDA application ANDA209587.

Identification & Billing

NDC Package Code
68071-2365-9
Package Description
90 TABLET, COATED in 1 BOTTLE
Product Code
68071-2365
11-Digit Billing Format
68071236509
RxNorm Crosswalk
  • RxCUI: 238154 - butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral Tablet
  • RxCUI: 238154 - acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet
  • RxCUI: 238154 - APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral Tablet

Clinical Specifications

Proprietary Name
Butalbital, Acetaminophen, Caffeine
Dosage Form
-
Usage Information
Butalbital, acetaminophen and caffeine 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
Nucare Pharmaceuticals,inc.
FDA Application #
ANDA209587
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-05-2019
Listing Expiration
12-31-2024
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (68071-2365). Click a package code to view its specific billing and regulatory data.

68071-2365-3
30 TABLET, COATED in 1 BOTTLE
68071-2365-6
60 TABLET, COATED in 1 BOTTLE
68071-2365-8
180 TABLET, COATED 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 68071-2365-9 identifies a specific commercial package of 90 tablet, coated in 1 bottle of Butalbital, Acetaminophen, Caffeine, labeled by Nucare Pharmaceuticals,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 Nucare Pharmaceuticals,inc. on March 05, 2019. The current certification is valid through December 31, 2024.

How is this Nucare Pharmaceuticals,inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68071236509. 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)
68071-2365-9
11-Digit CMS (5-4-2)
68071-2365-09

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