Tramadol Hcl
NDC Package 80425-0101-2

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 discontinued by the firm.

Tramadol Hcl is see also Warning section. Marketed by Advanced Rx Pharmacy Of Tennessee, Llc, this product is identified by NDC 80425-0101 and is authorized under FDA application ANDA200491.

Identification & Billing

NDC Package Code
80425-0101-2
Package Description
60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Product Code
80425-0101
11-Digit Billing Format
80425010102

Clinical Specifications

Proprietary Name
Tramadol Hcl ER
Dosage Form
-
Usage Information
See also Warning section. This medication is used to help relieve moderate to moderately severe pain. Tramadol is similar to opioid analgesics. It works in the brain to change how your body feels and responds to pain.

Regulatory & Marketing

Labeler Name
Advanced Rx Pharmacy Of Tennessee, Llc
FDA Application #
ANDA200491
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-27-2012
End Marketing Date
01-31-2022
Listing Expiration
01-31-2022
Exclude Flag
D
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 80425-0101-2 identifies a specific commercial package of 60 tablet, film coated, extended release in 1 bottle of Tramadol Hcl ER, labeled by Advanced Rx Pharmacy Of Tennessee, 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 Advanced Rx Pharmacy Of Tennessee, Llc on June 27, 2012. The current certification is valid through January 31, 2022.

What are the primary indications for this medication?

See also Warning section. This medication is used to help relieve moderate to moderately severe pain. Tramadol is similar to opioid analgesics. It works in the brain to change how your body feels and responds to pain.

How is this Advanced Rx Pharmacy Of Tennessee, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 80425010102. 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)
80425-0101-2
11-Digit CMS (5-4-2)
80425-0101-02

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