Tramadol Hydrochloride
NDC Package 76519-1142-3

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 inactivated by the FDA.

Tramadol Hydrochloride is an opioid agonist indicated for the management of pain severe enough to require daily around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Marketed by H.j. Harkins Company, Inc., this product is identified by NDC 76519-1142 and is authorized under FDA application ANDA201384.

Identification & Billing

NDC Package Code
76519-1142-3
Package Description
30 TABLET, EXTENDED RELEASE in 1 VIAL, PLASTIC
Product Code
76519-1142
11-Digit Billing Format
76519114203
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 ER
Dosage Form
-
Usage Information
Tramadol hydrochloride is an opioid agonist indicated for the management of pain severe enough to require daily around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. (1) Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, 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. (1) Tramadol hydrochloride extended-release tablets are not indicated as an as-needed (prn) analgesic. (1)

Regulatory & Marketing

Labeler Name
H.j. Harkins Company, Inc.
FDA Application #
ANDA201384
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-15-2016
Listing Expiration
12-31-2019
Exclude Flag
I
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 (76519-1142). Click a package code to view its specific billing and regulatory data.

76519-1142-6
60 TABLET, EXTENDED RELEASE in 1 VIAL, PLASTIC

* 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 76519-1142-3 identifies a specific commercial package of 30 tablet, extended release in 1 vial, plastic of Tramadol Hydrochloride ER, labeled by H.j. Harkins Company, Inc.. 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 H.j. Harkins Company, Inc. on July 15, 2016. The current certification is valid through December 31, 2019.

How is this H.j. Harkins Company, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76519114203. 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)
76519-1142-3
11-Digit CMS (5-4-2)
76519-1142-03

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