Tramadol Hydrochloride And Acetaminophen
NDC Package 42549-569-60

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.

Tramadol Hydrochloride And Acetaminophen is tablet is indicated for the short-term (five days or less) management of acute pain. Marketed by Stat Rx Usa Llc, this product is identified by NDC 42549-569 and is authorized under FDA application ANDA077184.

Identification & Billing

NDC Package Code
42549-569-60
Package Description
60 TABLET, FILM COATED in 1 BOTTLE
Product Code
42549-569
11-Digit Billing Format
42549056960
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 tablet is indicated for the short-term (five days or less) management of acute pain.

Regulatory & Marketing

Labeler Name
Stat Rx Usa Llc
FDA Application #
ANDA077184
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-16-2005
Listing Expiration
12-31-2017
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 (42549-569). Click a package code to view its specific billing and regulatory data.

42549-569-02
112 TABLET, FILM COATED in 1 BOTTLE
42549-569-12
120 TABLET, FILM COATED in 1 BOTTLE
42549-569-30
30 TABLET, FILM COATED in 1 BOTTLE
42549-569-90
90 TABLET, FILM COATED in 1 BOTTLE

* 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 42549-569-60 identifies a specific commercial package of 60 tablet, film coated in 1 bottle of Tramadol Hydrochloride And Acetaminophen, labeled by Stat Rx Usa Llc. 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 Stat Rx Usa Llc on December 16, 2005. The current certification is valid through December 31, 2017.

How is this Stat Rx Usa Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42549056960. 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 (5-3-2)
42549-569-60
11-Digit CMS (5-4-2)
42549-0569-60

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