Tramadol Hydrochloride
NDC Package 71610-392-28
Package Information
Tramadol Hydrochloride is tablets are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Marketed by Aphena Pharma Solutions - Tennessee, Llc, this product is identified by NDC 71610-392 and is authorized under FDA application ANDA076003.
Identification & Billing
- RxCUI: 835603 - traMADol HCl 50 MG Oral Tablet
- RxCUI: 835603 - tramadol hydrochloride 50 MG Oral Tablet
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 71610 - Aphena Pharma Solutions - Tennessee, Llc
- 71610-392 - Tramadol Hydrochloride
- 71610-392-28 - 28 TABLET, COATED in 1 BOTTLE
- 71610-392 - Tramadol Hydrochloride
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 (71610-392). Click a package code to view its specific billing and regulatory data.
* 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 71610-392-28 identifies a specific commercial package of 28 tablet, coated in 1 bottle of Tramadol Hydrochloride, labeled by Aphena Pharma Solutions - Tennessee, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 28 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 Aphena Pharma Solutions - Tennessee, Llc on November 15, 2010. The current certification is valid through December 31, 2022.
How is this Aphena Pharma Solutions - Tennessee, Llc product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 71610039228. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 28 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.
