Syndros Solution
NDC Package 78613-201-30

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

Package Information

Syndros (dronabinol) solution is dronabinol is used to treat nausea and vomiting caused by cancer chemotherapy. This formulation utilizes a solution delivery system. Marketed by Benuvia Operations, Llc, this product is identified by NDC 78613-201 and is authorized under FDA application NDA205525.

Identification & Billing

NDC Package Code
78613-201-30
Package Description
1 BOTTLE, GLASS in 1 CARTON / 30 mL in 1 BOTTLE, GLASS
Product Code
78613-201
11-Digit Billing Format
78613020130
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Syndros
Non-Proprietary Name
Dronabinol
Substance Name
Dronabinol
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)
DRONABINOL 5 mg/mL
Pharmacologic Class
Usage Information
Dronabinol is used to treat nausea and vomiting caused by cancer chemotherapy. It is used when other drugs usually used to control nausea and vomiting have not worked well. Dronabinol is also used to treat loss of appetite and weight loss in people with HIV infection. Dronabinol (also called THC) is a man-made form of a natural substance in marijuana (cannabis).
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
Benuvia Operations, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA205525
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-01-2017
End Marketing Date
04-30-2027
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

Q0155
Source: PDAC
DRONABINOL (SYNDROS), 0.1 MG, ORAL, FDA APPROVED PRESCRIPTION ANTI-EMETIC, FOR USE AS A COMPLETE THERAPEUTIC SUBSTITUTE FOR AN IV ANTI-EMETIC AT THE TIME OF CHEMOTHERAPY TREATMENT, NOT TO EXCEED A 48 HOUR DOSAGE REGIMEN
HCPCS Dosage 0.1 MG
Units / Pkg

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 78613-201-30 identifies a specific commercial package of 1 bottle, glass in 1 carton / 30 ml in 1 bottle, glass of Syndros, a human prescription drug labeled by Benuvia Operations, Llc. This solution is formulated for oral use and contains dronabinol 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 Benuvia Operations, Llc on July 01, 2017.

What are the primary indications for this medication?

Dronabinol is used to treat nausea and vomiting caused by cancer chemotherapy. It is used when other drugs usually used to control nausea and vomiting have not worked well. Dronabinol is also used to treat loss of appetite and weight loss in people with HIV infection. Dronabinol (also called THC) is a man-made form of a natural substance in marijuana (cannabis).

How is this Benuvia Operations, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 78613020130. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
78613-201-30
11-Digit CMS (5-4-2)
78613-0201-30

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