Butalbital, Acetaminophen, Caffeine And Codeine Phosphate Capsule
NDC Package 0054-3000-01

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

Package Information

Butalbital, Acetaminophen, Caffeine And Codeine Phosphate capsules is butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are indicated for the management of the symptom complex of tension (or muscle contraction) headache when non-opioid analgesic and alternative treatments are inadequate. This formulation utilizes a capsule delivery system. Marketed by Hikma Pharmaceuticals Usa Inc., this product is identified by NDC 0054-3000 and is authorized under FDA application ANDA215138.

Identification & Billing

NDC Package Code
0054-3000-01
Package Description
100 CAPSULE in 1 BOTTLE
Product Code
0054-3000
11-Digit Billing Format
00054300001
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: 1431286 - butalbital 50 MG / acetaminophen 300 MG / caffeine 40 MG / codeine phosphate 30 MG Oral Capsule
  • RxCUI: 1431286 - acetaminophen 300 MG / butalbital 50 MG / caffeine 40 MG / codeine phosphate 30 MG Oral Capsule
  • RxCUI: 1431286 - APAP 300 MG / butalbital 50 MG / Caffeine 40 MG / Codeine Phosphate 30 MG Oral Capsule
  • RxCUI: 993943 - butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG / codeine phosphate 30 MG Oral Capsule
  • RxCUI: 993943 - acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG / codeine phosphate 30 MG Oral Capsule

Clinical Specifications

Proprietary Name
Butalbital, Acetaminophen, Caffeine And Codeine Phosphate
Non-Proprietary Name
Butalbital, Acetaminophen, Caffeine And Codeine Phosphate
Substance Name
Acetaminophen; Butalbital; Caffeine; Codeine Phosphate
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, Caffeine, and Codeine Phosphate Capsules are indicated for the management of the symptom complex of tension (or muscle contraction) headache when non-opioid analgesic and alternative treatments are inadequate. Limitations of UseBecause of the risks of addiction, abuse, and misuse with opioids and butalbital, even at recommended doses [see Warnings and Precautions (5.1)], reserve Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for use in patients for whom alternative treatment options [e.g., non-opioid, non-barbiturate analgesics]:•Have not been tolerated, or are not expected to be tolerated,•Have not provided adequate analgesia, or are not expected to provide adequate analgesia.
DEA Schedule
Schedule III (CIII) Substances

Regulatory & Marketing

Labeler Name
Hikma Pharmaceuticals Usa Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA215138
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-09-2022
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0054-3000-01 identifies a specific commercial package of 100 capsule in 1 bottle of Butalbital, Acetaminophen, Caffeine And Codeine Phosphate, a human prescription drug labeled by Hikma Pharmaceuticals Usa Inc.. This capsule is formulated for oral use and contains acetaminophen; butalbital; caffeine; codeine phosphate 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 Hikma Pharmaceuticals Usa Inc. on May 09, 2022. The current certification is valid through December 31, 2027.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00054300001. 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 (4-4-2)
0054-3000-01
11-Digit CMS (5-4-2)
00054-3000-01

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