Butalbital, Acetaminophen And Caffeine Solution
NDC Package 64950-290-16

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Butalbital, Acetaminophen And Caffeine solution is butalbital, acetaminophen and caffeine oral solution is 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 solution delivery system. Marketed by Genus Lifesciences Inc., this product is identified by NDC 64950-290 and is authorized under FDA application ANDA040387.

Identification & Billing

NDC Package Code
64950-290-16
Package Description
473 mL in 1 BOTTLE
Product Code
64950-290
11-Digit Billing Format
64950029016
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
473 ML
RxNorm Crosswalk
  • RxCUI: 756245 - butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG in 15 mL Oral Solution
  • RxCUI: 756245 - acetaminophen 21.7 MG/ML / butalbital 3.33 MG/ML / caffeine 2.67 MG/ML Oral Solution
  • RxCUI: 756245 - acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG per 15 ML Elixir
  • RxCUI: 756245 - acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG per 15 ML Syrup
  • RxCUI: 756245 - APAP 21.7 MG/ML / butalbital 3.33 MG/ML / Caffeine 2.67 MG/ML Oral Solution

Clinical Specifications

Proprietary Name
Butalbital, Acetaminophen And Caffeine
Non-Proprietary Name
Butalbital, Acetaminophen, And Caffeine
Substance Name
Acetaminophen; Butalbital; Caffeine
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Butalbital, acetaminophen and caffeine oral solution is 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
Genus Lifesciences Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA040387
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-01-2025
Listing Expiration
12-31-2026
Exclude Flag
N
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 64950-290-16 identifies a specific commercial package of 473 ml in 1 bottle of Butalbital, Acetaminophen And Caffeine, a human prescription drug labeled by Genus Lifesciences Inc.. This product is billed per "ML" milliliter and contains an estimated amount of 473 billable units per package. This solution 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 Genus Lifesciences Inc. on July 01, 2025. The current certification is valid through December 31, 2026.

How is this Genus Lifesciences Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64950029016. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 473 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)
64950-290-16
11-Digit CMS (5-4-2)
64950-0290-16

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