Tramadol Hydrochloride Tablet, Film Coated
NDC Package 71610-006-40
Package Information
Tramadol Hydrochloride tablets are indicated for the management of pain in adults that is severe enough to require an opioid analgesic and for which alternative treatments are inadequate. This formulation utilizes a tablet, film coated delivery system. Marketed by Aphena Pharma Solutions - Tennessee, Llc, this product is identified by NDC 71610-006 and is authorized under FDA application ANDA075977.
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
- 71610-006 - Tramadol Hydrochloride
- 71610-006-40 - 40 TABLET, FILM COATED in 1 BOTTLE
- 71610-006 - 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 (71610-006). 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 71610-006-40 identifies a specific commercial package of 40 tablet, film coated in 1 bottle of Tramadol Hydrochloride, a human prescription drug labeled by Aphena Pharma Solutions - Tennessee, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 40 billable units per package. This tablet, film coated 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 Aphena Pharma Solutions - Tennessee, Llc on August 24, 2017. The current certification is valid through December 31, 2026.
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: 71610000640. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 40 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.
