Diacomit Capsule
NDC Package 68418-7939-6

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

Package Information

Diacomit (stiripentol) capsules is dIACOMIT is indicated for the treatment of seizures associated with Dravet syndrome (DS) in patients 2 years of age and older taking clobazam. This formulation utilizes a capsule delivery system. Marketed by Biocodex, Inc., this product is identified by NDC 68418-7939 and is authorized under FDA application NDA206709.

Identification & Billing

NDC Package Code
68418-7939-6
Package Description
1 BOTTLE in 1 CARTON / 60 CAPSULE in 1 BOTTLE
Product Code
68418-7939
11-Digit Billing Format
68418793906
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Diacomit
Non-Proprietary Name
Stiripentol
Substance Name
Stiripentol
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
STIRIPENTOL 250 mg/1
Usage Information
DIACOMIT is indicated for the treatment of seizures associated with Dravet syndrome (DS) in patients 2 years of age and older taking clobazam. There are no clinical data to support the use of DIACOMIT as monotherapy in Dravet syndrome.

Regulatory & Marketing

Labeler Name
Biocodex, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA206709
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-21-2018
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 68418-7939-6 identifies a specific commercial package of 1 bottle in 1 carton / 60 capsule in 1 bottle of Diacomit, a human prescription drug labeled by Biocodex, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This capsule is formulated for oral use and contains stiripentol 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 Biocodex, Inc. on August 21, 2018. The current certification is valid through December 31, 2027.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68418793906. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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 (5-4-1)
68418-7939-6
11-Digit CMS (5-4-2)
68418-7939-06

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