Tramadol Hydrochloride Tablet, Extended Release
NDC Package 67046-1527-3

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

Package Information

Tramadol Hydrochloride tablets is tramadol hydrochloride extended-release tablet is indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. This formulation utilizes a tablet, extended release delivery system. Marketed by Coupler Llc, this product is identified by NDC 67046-1527 and is authorized under FDA application ANDA200503.

Identification & Billing

NDC Package Code
67046-1527-3
Package Description
30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Product Code
67046-1527
11-Digit Billing Format
67046152703
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 Hydrochloride
Non-Proprietary Name
Tramadol Hydrochloride
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
Tramadol hydrochloride extended-release tablet is indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. Limitations of UseBecause of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosages or duration, and because of the greater risks of overdose and death with extended-release opioid formulations [see Warnings and Precautions ( 5.1)] , reserve tramadol hydrochloride extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Tramadol hydrochloride extended-release tablet is not indicated as an as-needed (prn) analgesic.
DEA Schedule
Schedule IV (CIV) Substances

Regulatory & Marketing

Labeler Name
Coupler Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA200503
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-27-2025
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 67046-1527-3 identifies a specific commercial package of 30 tablet, extended release in 1 blister pack of Tramadol Hydrochloride, a human prescription drug labeled by Coupler Llc. 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 Coupler Llc on February 27, 2025. The current certification is valid through December 31, 2026.

How is this Coupler Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67046152703. 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)
67046-1527-3
11-Digit CMS (5-4-2)
67046-1527-03

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