Hydrocodone Bitartrate And Ibuprofen
NDC Package 67296-1655-7

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 Ibuprofen is tablets are indicated for the short-term management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Marketed by Redpharm Drug, Inc., this product is identified by NDC 67296-1655 and is authorized under FDA application ANDA204575.

Identification & Billing

NDC Package Code
67296-1655-7
Package Description
15 TABLET, FILM COATED in 1 BOTTLE
Product Code
67296-1655
11-Digit Billing Format
67296165507

Clinical Specifications

Proprietary Name
Hydrocodone Bitartrate And Ibuprofen
Dosage Form
-
Usage Information
Hydrocodone Bitartrate and Ibuprofen Tablets are indicated for the short-term management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of UseCarefully consider the potential benefits and risks of Hydrocodone Bitartrate and Ibuprofen Tablets and other treatment options before deciding to use Hydrocodone Bitartrate and Ibuprofen Tablets Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals (see WARNINGS: Cardiovascular Thrombotic Events, Gastrointestinal Bleeding, Ulceration, and Perforation). Do not use Hydrocodone Bitartrate and Ibuprofen Tablets for the treatment of conditions such as osteoarthritis or rheumatoid arthritis. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses (see WARNINGS: Addiction, Abuse, and Misuse), reserve Hydrocodone Bitartrate and Ibuprofen Tablets for use in patients for whom alternative treatment options (e.g., non-opioid 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
Redpharm Drug, Inc.
FDA Application #
ANDA204575
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-01-2019
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 67296-1655-7 identifies a specific commercial package of 15 tablet, film coated in 1 bottle of Hydrocodone Bitartrate And Ibuprofen, 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 January 01, 2019. 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: 67296165507. 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)
67296-1655-7
11-Digit CMS (5-4-2)
67296-1655-07

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