NDC Package 68418-7940-6 Diacomit

Stiripentol Capsule Oral - View Billable Units, 11-Digit Format, RxNorm

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
68418-7940-6
Package Description:
1 BOTTLE in 1 CARTON / 60 CAPSULE in 1 BOTTLE
Product Code:
Proprietary Name:
Diacomit
Non-Proprietary Name:
Stiripentol
Substance Name:
Stiripentol
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.
11-Digit NDC Billing Format:
68418794006
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
NDC to RxNorm Crosswalk:
Product Type:
Human Prescription Drug
Labeler Name:
Biocodex, Inc.
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(s):
Oral - Administration to or by way of the mouth.
Active Ingredient(s):
Sample Package:
No
FDA Application Number:
NDA206709
Marketing Category:
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date:
08-21-2018
Listing Expiration Date:
12-31-2025
Exclude Flag:
N
Code Structure:

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.

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Frequently Asked Questions

What is NDC 68418-7940-6?

The NDC Packaged Code 68418-7940-6 is assigned to a package of 1 bottle in 1 carton / 60 capsule in 1 bottle of Diacomit, a human prescription drug labeled by Biocodex, Inc.. The product's dosage form is capsule and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package.

Is NDC 68418-7940 included in the NDC Directory?

Yes, Diacomit with product code 68418-7940 is active and included in the NDC Directory. The product was first marketed by Biocodex, Inc. on August 21, 2018 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 68418-7940-6?

The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 1.

What is the 11-digit format for NDC 68418-7940-6?

The 11-digit format is 68418794006. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-4-1 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-4-168418-7940-65-4-268418-7940-06