Tramadol Hydrochloride And Acetaminophen
NDC Package 68071-2831-2

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.

Tramadol Hydrochloride And Acetaminophen is tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of UseTramadol hydrochloride and acetaminophen tablets are indicated for short-term use of five days or less. Marketed by Nucare Pharmaceuticals,inc., this product is identified by NDC 68071-2831 and is authorized under FDA application ANDA077184.

Identification & Billing

NDC Package Code
68071-2831-2
Package Description
20 TABLET, FILM COATED in 1 BOTTLE
Product Code
68071-2831
11-Digit Billing Format
68071283102
RxNorm Crosswalk
  • RxCUI: 836395 - traMADol HCl 37.5 MG / acetaminophen 325 MG Oral Tablet
  • RxCUI: 836395 - acetaminophen 325 MG / tramadol hydrochloride 37.5 MG Oral Tablet
  • RxCUI: 836395 - APAP 325 MG / tramadol hydrochloride 37.5 MG Oral Tablet

Clinical Specifications

Proprietary Name
Tramadol Hydrochloride And Acetaminophen
Dosage Form
-
Usage Information
Tramadol hydrochloride and acetaminophen tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of UseTramadol hydrochloride and acetaminophen tablets are indicated for short-term use of five days or less. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions ( 5.1)] , reserve tramadol hydrochloride and acetaminophen 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
Nucare Pharmaceuticals,inc.
FDA Application #
ANDA077184
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-16-2005
Listing Expiration
12-31-2024
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 68071-2831-2 identifies a specific commercial package of 20 tablet, film coated in 1 bottle of Tramadol Hydrochloride And Acetaminophen, labeled by Nucare Pharmaceuticals,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 Nucare Pharmaceuticals,inc. on December 16, 2005. The current certification is valid through December 31, 2024.

How is this Nucare Pharmaceuticals,inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68071283102. 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)
68071-2831-2
11-Digit CMS (5-4-2)
68071-2831-02

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