Diacomit (stiripentol) NDC 68418-7942

NDC codes

FDA NDC Directory

Product NDC (as listed)68418-7942Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68418-7942Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
68418-7942-6	68418794206	60 PACKET in 1 CARTON (68418-7942-6) / 1 POWDER, FOR SUSPENSION in 1 PACKETMarketed from Aug 21, 2018

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Diacomit
Generic name (nonproprietary): stiripentol
Active ingredients: Stiripentol — 500 mg/1
Dosage form: Powder, For suspension
Route: Oral
Labeler: BIOCODEX, INC.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 207223
Marketing start: Aug 21, 2018
Listing expires: Dec 31, 2027
Identifiers: Product ID 68418-7942_7c968964-991e-4ec2-bc03-ef062b5bb0f9SPL ID 7c968964-991e-4ec2-bc03-ef062b5bb0f9SPL set ID 58304ba8-9779-4658-811e-94ffe08c3f16RxCUI 2054973, 2054979, 2054981, 2054983, 2055011, 2055014, 2055015, 2055016UNII R02XOT8V8I

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N468418794206 followed by a unit qualifier and the quantity

Package 68418-7942-06. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Apr 27, 2026.

Indications (excerpt from the label)

DIACOMIT is indicated for the treatment of seizures associated with Dravet syndrome (DS) in patients taking clobazam who are 6 months of age and older and weighing 7 kg or more. There are no clinical data to support the use of DIACOMIT as monotherapy in Dravet syndrome. DIACOMIT is indicated for the treatment of seizures associated with Dravet syndrome in patients taking clobazam who are 6 months of age and older and weighing 7 kg or more . There are no clinical data to support the use of DIACOMIT as monotherapy in Dravet syndrome. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 207223

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 207223
Product	Strength	Form · route	Labeler	Product NDC
Diacomitstiripentol	Stiripentol 250 mg/1	Powder, For suspensionOral	BIOCODEX, INC.	68418-7941