Tramadol Hcl Tablet, Extended Release
NDC Package 80425-0141-2

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

Tramadol Hcl tablets is see also Warning section. This formulation utilizes a tablet, extended release delivery system. Marketed by Advanced Rx Pharmacy Of Tennessee, Llc, this product is identified by NDC 80425-0141 and is authorized under FDA application ANDA201384.

Identification & Billing

NDC Package Code
80425-0141-2
Package Description
60 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code
80425-0141
11-Digit Billing Format
80425014102
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA
RxNorm Crosswalk
  • RxCUI: 833709 - traMADol HCl 100 MG 24HR Extended Release Oral Tablet
  • RxCUI: 833709 - 24 HR tramadol hydrochloride 100 MG Extended Release Oral Tablet
  • RxCUI: 833709 - tramadol hydrochloride 100 MG 24 HR Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Tramadol Hcl ER
Non-Proprietary Name
Tramadol Hcl
Substance Name
Tramadol Hydrochloride
Dosage Form
Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
TRAMADOL HYDROCHLORIDE 100 mg/1
Pharmacologic Class
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.
DEA Schedule
Schedule IV (CIV) Substances

Regulatory & Marketing

Labeler Name
Advanced Rx Pharmacy Of Tennessee, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA201384
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-12-2011
Listing Expiration
12-31-2026
Exclude Flag
N
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 (80425-0141). Click a package code to view its specific billing and regulatory data.

80425-0141-1
30 TABLET, EXTENDED RELEASE in 1 BOTTLE
80425-0141-3
90 TABLET, EXTENDED RELEASE 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 80425-0141-2 identifies a specific commercial package of 60 tablet, extended release in 1 bottle of Tramadol Hcl ER, a human prescription drug labeled by Advanced Rx Pharmacy Of Tennessee, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 60 billable units per package. This tablet, extended release is formulated for oral use and contains tramadol hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Advanced Rx Pharmacy Of Tennessee, Llc on December 12, 2011. The current certification is valid through December 31, 2026.

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: 80425014102. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 60 total billable units per package. 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)
80425-0141-2
11-Digit CMS (5-4-2)
80425-0141-02

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