Butalbital, Acetaminophen, Caffeine, And Codeine Phosphate
NDC Package 71335-0653-2
Package Information
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.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. Marketed by Bryant Ranch Prepack, this product is identified by NDC 71335-0653 and is authorized under FDA application ANDA075929.
Identification & Billing
- 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
Regulatory & Marketing
Hierarchy Structure
- 71335 - Bryant Ranch Prepack
- 71335-0653 - Butalbital, Acetaminophen, Caffeine, And Codeine Phosphate
- 71335-0653-2 - 90 CAPSULE in 1 BOTTLE
- 71335-0653 - Butalbital, Acetaminophen, Caffeine, And Codeine Phosphate
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 (71335-0653). Click a package code to view its specific billing and regulatory data.
* 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 71335-0653-2 identifies a specific commercial package of 90 capsule in 1 bottle of Butalbital, Acetaminophen, Caffeine, And Codeine Phosphate, labeled by Bryant Ranch Prepack. 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 Bryant Ranch Prepack on April 22, 2002. The current certification is valid through September 30, 2022.
How is this Bryant Ranch Prepack product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 71335065302. 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:
Note: The zero is added to the Package segment to maintain the 5-4-2 structure.
