Tramadol Hydrochloride
NDC Package 76218-0708-5

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 discontinued by the firm.

Tramadol Hydrochloride is a . Marketed by Kle 2, Inc., this product is identified by NDC 76218-0708 and is authorized under FDA application NDA022370.

Identification & Billing

NDC Package Code
76218-0708-5
Package Description
500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Product Code
76218-0708
11-Digit Billing Format
76218070805
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
500 EA

Clinical Specifications

Proprietary Name
Tramadol Hydrochloride
Dosage Form
-

Regulatory & Marketing

Labeler Name
Kle 2, Inc.
FDA Application #
NDA022370
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-14-2012
End Marketing Date
10-30-2015
Listing Expiration
10-30-2015
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (76218-0708). Click a package code to view its specific billing and regulatory data.

76218-0708-1
1000 CAPSULE, 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 76218-0708-5 identifies a specific commercial package of 500 capsule, extended release in 1 bottle of Tramadol Hydrochloride, labeled by Kle 2, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 500 billable units per package. 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 Kle 2, Inc. on March 14, 2012. The current certification is valid through October 30, 2015.

How is this Kle 2, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76218070805. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 500 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)
76218-0708-5
11-Digit CMS (5-4-2)
76218-0708-05

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