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  4. NDC Product Code: 68418-7941 Diacomit

NDC 68418-7941 Diacomit

Stiripentol Powder, For Suspension Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 68418-7941?
  5. Diacomit Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Patient Education

Product Information

Get all the details for National Drug Code (NDC) 68418-7941 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
68418-7941
Proprietary Name:
Diacomit
Non-Proprietary Name: [1]
Stiripentol
Substance Name: [2]
Stiripentol
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Powder, For Suspension - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a suspension (a liquid preparation containing the solid particles dispersed in the liquid vehicle).
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.
Labeler Name: [5]
Biocodex, Inc.
Labeler Code:
68418
Product Label ID:
58304ba8-9779-4658-811e-94ffe08c3f16
FDA Application Number: [6]
NDA207223
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date: [9]
08-21-2018
Listing Expiration Date: [11]
12-31-2025
Exclude Flag: [12]
N
Code Navigator:

Product Characteristics

Color(s):
PINK (C48328)
WHITE (C48325)
Shape:
CAPSULE (C48336)
Size(s):
15 MM
18 MM
Imprint(s):
DIACOMIT;250MG
DIACOMIT;500MG
Score:
1
Flavor(s):
TUTTI FRUTTI (C73420)

Code Structure Chart

Product Details

What is NDC 68418-7941?

The NDC code 68418-7941 is assigned by the FDA to the product Diacomit which is a human prescription drug product labeled by Biocodex, Inc.. The generic name of Diacomit is stiripentol. The product's dosage form is powder, for suspension and is administered via oral form. The product is distributed in a single package with assigned NDC code 68418-7941-6 60 packet in 1 carton / 1 powder, for suspension in 1 packet. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Diacomit?

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.

What are Diacomit Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

Which are Diacomit UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Diacomit Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Diacomit?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

* Please review the disclaimer below.

Patient Education

Stiripentol


Stiripentol is used along with clobazam (Onfi®, Sympazan®) to control seizures in adults and children 6 months of age and older who weigh at least 7 kg (15 pounds) who have Dravet syndrome (a disorder that begins in early childhood and causes seizures and later may lead to developmental delays and changes in eating, balance, and walking). Stiripentol is in a class of medications called anticonvulsants. It works by decreasing abnormal excitement activity in the brain.
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* Please review the disclaimer below.

Product Footnotes

[1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

[2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

[3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

[4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".