Hydrocodone Bitartrate And Acetaminophen
NDC Package 67296-1476-7

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

Package Information

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

Hydrocodone Bitartrate And Acetaminophen is oral Solution is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of UseBecause of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see  WARNINGS], reserve Hydrocodone Bitartrate and Acetaminophen Oral Solution for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): have not been tolerated, or are not expected to be toleratedhave not provided adequate analgesia, or are not expected to provide adequate analgesia. Marketed by Redpharm Drug, Inc, this product is identified by NDC 67296-1476 and is authorized under FDA application ANDA040838.

Identification & Billing

NDC Package Code
67296-1476-7
Package Description
118 mL in 1 BOTTLE
Product Code
67296-1476
11-Digit Billing Format
67296147607
RxNorm Crosswalk
  • RxCUI: 856940 - HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG in 15 mL Oral Solution
  • RxCUI: 856940 - acetaminophen 21.7 MG/ML / hydrocodone bitartrate 0.5 MG/ML Oral Solution
  • RxCUI: 856940 - acetaminophen 108 MG / hydrocodone bitartrate 2.5 MG per 5 ML Oral Solution
  • RxCUI: 856940 - acetaminophen 217 MG / hydrocodone bitartrate 5 MG per 10 ML Oral Solution
  • RxCUI: 856940 - acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG per 15 ML Oral Solution

Clinical Specifications

Proprietary Name
Hydrocodone Bitartrate And Acetaminophen
Dosage Form
-
Usage Information
Hydrocodone Bitartrate and Acetaminophen Oral Solution is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of UseBecause of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see  WARNINGS], reserve Hydrocodone Bitartrate and Acetaminophen Oral Solution for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): have not been tolerated, or are not expected to be toleratedhave not provided adequate analgesia, or are not expected to provide adequate analgesia

Regulatory & Marketing

Labeler Name
Redpharm Drug, Inc
FDA Application #
ANDA040838
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-29-2013
Listing Expiration
12-31-2025
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 67296-1476-7 identifies a specific commercial package of 118 ml in 1 bottle of Hydrocodone Bitartrate And Acetaminophen, labeled by Redpharm Drug, 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 Redpharm Drug, Inc on July 29, 2013. The current certification is valid through December 31, 2025.

How is this Redpharm Drug, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67296147607. 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)
67296-1476-7
11-Digit CMS (5-4-2)
67296-1476-07

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