Epidiolex Solution
NDC Package 70127-100-10

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

Epidiolex (cannabidiol) solution is a medication used to treat seizures due to certain medical conditions (such as Lennox-Gastaut syndrome, Dravet syndrome, tuberous sclerosis complex - TSC). This formulation utilizes a solution delivery system. Marketed by Jazz Pharmaceuticals, Inc., this product is identified by NDC 70127-100 and is authorized under FDA application NDA210365.

Identification & Billing

NDC Package Code
70127-100-10
Package Description
1 BOTTLE, GLASS in 1 CARTON / 100 mL in 1 BOTTLE, GLASS (70127-100-01)
Product Code
70127-100
11-Digit Billing Format
70127010010
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Epidiolex
Non-Proprietary Name
Cannabidiol
Substance Name
Cannabidiol
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)
CANNABIDIOL 100 mg/mL
Pharmacologic Class
Usage Information
This medication is used to treat seizures due to certain medical conditions (such as Lennox-Gastaut syndrome, Dravet syndrome, tuberous sclerosis complex - TSC). It is not known how this medication works for these seizures. Cannabidiol belongs to a class of drugs known as cannabinoids.

Regulatory & Marketing

Labeler Name
Jazz Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA210365
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-05-2018
Listing Expiration
12-31-2027
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (70127-100). Click a package code to view its specific billing and regulatory data.

70127-100-60
1 BOTTLE, GLASS in 1 CARTON / 60 mL in 1 BOTTLE, GLASS (70127-100-06)

* 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 70127-100-10 identifies a specific commercial package of 1 bottle, glass in 1 carton / 100 ml in 1 bottle, glass (70127-100-01) of Epidiolex, a human prescription drug labeled by Jazz Pharmaceuticals, Inc.. This solution is formulated for oral use and contains cannabidiol 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 Jazz Pharmaceuticals, Inc. on October 05, 2018. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used to treat seizures due to certain medical conditions (such as Lennox-Gastaut syndrome, Dravet syndrome, tuberous sclerosis complex - TSC). It is not known how this medication works for these seizures. Cannabidiol belongs to a class of drugs known as cannabinoids.

How is this Jazz Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70127010010. 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)
70127-100-10
11-Digit CMS (5-4-2)
70127-0100-10

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