Butalbital, Acetaminophen, And Caffeine Tablet
NDC Package 68071-3249-2

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

Butalbital, Acetaminophen, And Caffeine tablets is butalbital, acetaminophen, and caffeine tablets, USP 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. This formulation utilizes a tablet delivery system. Marketed by Nucare Pharmaceuticals, Inc., this product is identified by NDC 68071-3249 and is authorized under FDA application ANDA200243.

Identification & Billing

NDC Package Code
68071-3249-2
Package Description
20 TABLET in 1 BOTTLE
Product Code
11-Digit Billing Format
68071324902
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, And Caffeine
Non-Proprietary Name
Butalbital, Acetaminophen, And Caffeine
Substance Name
Acetaminophen; Butalbital; Caffeine
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Usage Information
Butalbital, acetaminophen, and caffeine tablets, USP 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.
DEA Schedule
Schedule III (CIII) Substances

Regulatory & Marketing

Labeler Name
Nucare Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA200243
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-13-2012
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

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 (68071-3249). Click a package code to view its specific billing and regulatory data.

10 TABLET in 1 BOTTLE
30 TABLET in 1 BOTTLE
60 TABLET 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 68071-3249-2 identifies a specific commercial package of 20 tablet in 1 bottle of Butalbital, Acetaminophen, And Caffeine, a human prescription drug labeled by Nucare Pharmaceuticals, Inc.. This tablet is formulated for oral use and contains acetaminophen; butalbital; caffeine as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Nucare Pharmaceuticals, Inc. on September 13, 2012. The current certification is valid through December 31, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68071324902. 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)
68071-3249-2
11-Digit CMS (5-4-2)
68071-3249-02

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