Butalbital, Acetaminophen And Caffeine Capsule
NDC Package 70010-044-01

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 capsules is butalbital, Acetaminophen and Caffeine capsules are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. This formulation utilizes a capsule delivery system. Marketed by Granules Pharmaceuticals Inc., this product is identified by NDC 70010-044 and is authorized under FDA application ANDA213321.

Identification & Billing

NDC Package Code
70010-044-01
Package Description
100 CAPSULE in 1 BOTTLE
Product Code
70010-044
11-Digit Billing Format
70010004401
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk
  • RxCUI: 889520 - butalbital 50 MG / acetaminophen 300 MG / caffeine 40 MG Oral Capsule
  • RxCUI: 889520 - acetaminophen 300 MG / butalbital 50 MG / caffeine 40 MG Oral Capsule
  • RxCUI: 889520 - APAP 300 MG / butalbital 50 MG / caffeine 40 MG Oral Capsule

Clinical Specifications

Proprietary Name
Butalbital, Acetaminophen And Caffeine
Non-Proprietary Name
Butalbital, Acetaminophen And Caffeine
Substance Name
Acetaminophen; Butalbital; Caffeine
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Butalbital, Acetaminophen and Caffeine capsules 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
Granules Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA213321
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-05-2020
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (70010-044). Click a package code to view its specific billing and regulatory data.

70010-044-05
500 CAPSULE 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 70010-044-01 identifies a specific commercial package of 100 capsule in 1 bottle of Butalbital, Acetaminophen And Caffeine, a human prescription drug labeled by Granules Pharmaceuticals Inc.. This capsule 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 Granules Pharmaceuticals Inc. on May 05, 2020. The current certification is valid through December 31, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70010004401. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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)
70010-044-01
11-Digit CMS (5-4-2)
70010-0044-01

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