Butalbital, Acetaminophen, Caffeine, And Codeine Phosphate
NDC Package 0722-6670-01

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

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Butalbital, Acetaminophen, Caffeine, And Codeine Phosphate 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. Marketed by Nexgen Pharma, Inc., this product is identified by NDC 0722-6670 and is authorized under FDA application ANDA076560.

Identification & Billing

NDC Package Code
0722-6670-01
Package Description
100 CAPSULE in 1 BOTTLE, PLASTIC
Product Code
0722-6670
11-Digit Billing Format
00722667001
RxNorm Crosswalk
  • 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
  • RxCUI: 993943 - APAP 325 MG / butalbital 50 MG / caffeine 40 MG / codeine phosphate 30 MG Oral Capsule

Clinical Specifications

Proprietary Name
Butalbital, Acetaminophen, Caffeine, And Codeine Phosphate
Dosage Form
-
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.

Regulatory & Marketing

Labeler Name
Nexgen Pharma, Inc.
FDA Application #
ANDA076560
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-10-2004
Listing Expiration
12-31-2021
Exclude Flag
I
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 (0722-6670). Click a package code to view its specific billing and regulatory data.

0722-6670-05
500 CAPSULE 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 0722-6670-01 identifies a specific commercial package of 100 capsule in 1 bottle, plastic of Butalbital, Acetaminophen, Caffeine, And Codeine Phosphate, labeled by Nexgen Pharma, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Nexgen Pharma, Inc. on June 10, 2004. The current certification is valid through December 31, 2021.

How is this Nexgen Pharma, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00722667001. 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)
0722-6670-01
11-Digit CMS (5-4-2)
00722-6670-01

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