Tramadol Hydrochloride Solution
NDC Package 52817-615-16

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

Package Information

Tramadol Hydrochloride solution is tramadol hydrochloride oral solution is indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. This formulation utilizes a solution delivery system. Marketed by Trupharma, Llc, this product is identified by NDC 52817-615 and is authorized under FDA application NDA214044.

Identification & Billing

NDC Package Code
52817-615-16
Package Description
473 mL in 1 BOTTLE
Product Code
52817-615
11-Digit Billing Format
52817061516
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
473 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Tramadol Hydrochloride
Non-Proprietary Name
Tramadol Hydrochloride
Substance Name
Tramadol Hydrochloride
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
TRAMADOL HYDROCHLORIDE 5 mg/mL
Pharmacologic Class
Usage Information
Tramadol hydrochloride oral solution is indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
DEA Schedule
Schedule IV (CIV) Substances

Regulatory & Marketing

Labeler Name
Trupharma, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA214044
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
09-11-2020
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 52817-615-16 identifies a specific commercial package of 473 ml in 1 bottle of Tramadol Hydrochloride, a human prescription drug labeled by Trupharma, Llc. This product is billed per "ML" milliliter and contains an estimated amount of 473 billable units per package. This solution 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 Trupharma, Llc on September 11, 2020. The current certification is valid through December 31, 2026.

How is this Trupharma, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52817061516. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 473 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 (5-3-2)
52817-615-16
11-Digit CMS (5-4-2)
52817-0615-16

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