Butalbital, Acetaminophen And Caffeine Tablet
NDC Package 70518-4601-2

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

Butalbital, Acetaminophen And Caffeine tablets 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. This formulation utilizes a tablet delivery system. Marketed by Remedyrepack Inc., this product is identified by NDC 70518-4601 and is authorized under FDA application ANDA214287.

Identification & Billing

NDC Package Code
70518-4601-2
Package Description
120 TABLET in 1 BOTTLE, PLASTIC
Product Code
70518-4601
11-Digit Billing Format
70518460102
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.
Active Ingredient(s)
Pharmacologic Class
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.
DEA Schedule
Schedule III (CIII) Substances

Regulatory & Marketing

Labeler Name
Remedyrepack Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA214287
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-16-2026
Listing Expiration
12-31-2027
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (70518-4601). Click a package code to view its specific billing and regulatory data.

70518-4601-0
90 TABLET in 1 BOTTLE, PLASTIC
70518-4601-1
150 TABLET in 1 BOTTLE, PLASTIC

* 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 70518-4601-2 identifies a specific commercial package of 120 tablet in 1 bottle, plastic of Butalbital, Acetaminophen And Caffeine, a human prescription drug labeled by Remedyrepack 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 Remedyrepack Inc. on April 16, 2026. The current certification is valid through December 31, 2027.

How is this Remedyrepack Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70518460102. 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)
70518-4601-2
11-Digit CMS (5-4-2)
70518-4601-02

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