Butalbital, Aspirin, Caffeine And Codeine Phosphate Capsule
NDC Package 69238-1993-1

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

Package Information

Butalbital, Aspirin, Caffeine And Codeine Phosphate capsules is butalbital, Aspirin, Caffeine and Codeine Phosphate Capsules are indicated for the relief of the symptom complex of tension (or muscle contraction) headache.Evidence supporting the efficacy of butalbital, aspirin, caffeine and codeine phosphate capsules is derived from 2 multi-clinic trials that compared patients with tension headache randomly assigned to 4 parallel treatments: 1) butalbital, aspirin, caffeine and codeine; 2) codeine; 3) butalbital, aspirin and caffeine; 4) placebo. This formulation utilizes a capsule delivery system. Marketed by Amneal Pharmaceuticals Of New York, Llc, this product is identified by NDC 69238-1993 and is authorized under FDA application ANDA074951.

Identification & Billing

NDC Package Code
69238-1993-1
Package Description
100 CAPSULE in 1 BOTTLE
Product Code
69238-1993
11-Digit Billing Format
69238199301
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: 994237 - butalbital 50 MG / aspirin 325 MG / caffeine 40 MG / codeine phosphate 30 MG Oral Capsule
  • RxCUI: 994237 - aspirin 325 MG / butalbital 50 MG / caffeine 40 MG / codeine phosphate 30 MG Oral Capsule
  • RxCUI: 994237 - ASA 325 MG / butalbital 50 MG / caffeine 40 MG / codeine phosphate 30 MG Oral Capsule

Clinical Specifications

Proprietary Name
Butalbital, Aspirin, Caffeine And Codeine Phosphate
Non-Proprietary Name
Butalbital, Aspirin, Caffeine And Codeine Phosphate
Substance Name
Aspirin; 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, Aspirin, Caffeine and Codeine Phosphate Capsules are indicated for the relief of the symptom complex of tension (or muscle contraction) headache.Evidence supporting the efficacy of butalbital, aspirin, caffeine and codeine phosphate capsules is derived from 2 multi-clinic trials that compared patients with tension headache randomly assigned to 4 parallel treatments: 1) butalbital, aspirin, caffeine and codeine; 2) codeine; 3) butalbital, aspirin and caffeine; 4) placebo. Response was assessed over the course of the first 4 hours of each of 2 distinct headaches, separated by at least 24 hours. The combination product of butalbital, aspirin, caffeine and codeine proved statistically significantly superior to each of its components and to placebo on measures of pain relief.Evidence supporting the efficacy and safety of butalbital, aspirin, caffeine and codeine in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because codeine and butalbital are habit-forming and potentially abusable.
DEA Schedule
Schedule III (CIII) Substances

Regulatory & Marketing

Labeler Name
Amneal Pharmaceuticals Of New York, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA074951
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-01-2019
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 69238-1993-1 identifies a specific commercial package of 100 capsule in 1 bottle of Butalbital, Aspirin, Caffeine And Codeine Phosphate, a human prescription drug labeled by Amneal Pharmaceuticals Of New York, Llc. This capsule is formulated for oral use and contains aspirin; 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 Amneal Pharmaceuticals Of New York, Llc on April 01, 2019. The current certification is valid through December 31, 2027.

How is this Amneal Pharmaceuticals Of New York, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69238199301. 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 (5-4-1)
69238-1993-1
11-Digit CMS (5-4-2)
69238-1993-01

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