Tramadol Hcl Er Tablet, Extended Release
NDC Package 72189-521-30

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Tramadol Hcl Er tablets is see also Warning section. This formulation utilizes a tablet, extended release delivery system. Marketed by Direct_rx, this product is identified by NDC 72189-521 and is authorized under FDA application ANDA200503.

Identification & Billing

NDC Package Code
72189-521-30
Package Description
30 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code
72189-521
11-Digit Billing Format
72189052130
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk
  • RxCUI: 833713 - traMADol HCl 300 MG 24HR Extended Release Oral Tablet
  • RxCUI: 833713 - 24 HR tramadol hydrochloride 300 MG Extended Release Oral Tablet
  • RxCUI: 833713 - tramadol hydrochloride 300 MG 24 HR Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Tramadol Hcl Er
Non-Proprietary Name
Tramadol Hcl Er
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 300 mg/1
Pharmacologic Class
Usage Information
See also Warning section. This medication is used to help relieve severe ongoing 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
Direct_rx
Product Type
Human Prescription Drug
FDA Application #
ANDA200503
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-08-2023
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 72189-521-30 identifies a specific commercial package of 30 tablet, extended release in 1 bottle of Tramadol Hcl Er, a human prescription drug labeled by Direct_rx. This product is billed for "EA" each discreet unit and contains an estimated amount of 30 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 Direct_rx on November 08, 2023. 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 severe ongoing 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 Direct_rx product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72189052130. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 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 (5-3-2)
72189-521-30
11-Digit CMS (5-4-2)
72189-0521-30

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