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Diacomit

stiripentol · Capsule

Prescription NDA RLD
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Diacomit
Generic name
stiripentol
Dosage form
Capsule
Route
Oral
Marketing category
NDA · NDA
Labeler
BIOCODEX, INC.
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
2
Packages
2
Data completeness
54% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Stiripentol 250 mg/1 2054973 View
Stiripentol 500 mg/1 2054973 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Capsule
Route of administration
Oral
Presentations
4

Regulatory status

Source: Drugs@FDANDC Directory
Application number
206709
Application type
NDA · New Drug Application
Approval date
August 20, 2018
Sponsor
BIOCODEX SA
Products on application
2
Submissions recorded
3
Products approved under application 206709.
Product Trade name Form Strength Ingredient Status TE Flags
206709-001 DIACOMIT CAPSULE STIRIPENTOL Prescription — RLD
206709-002 DIACOMIT CAPSULE STIRIPENTOL Prescription — RLD RS

Therapeutic equivalence

Source: Orange Book
TE code
—
Reference Listed Drug
Yes
Reference Standard
Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Patents and exclusivity

Source: Orange Book
Regulatory exclusivity periods.
Code Expires Product
ODE-403 July 14, 2029 001
ODE-403 July 14, 2029 002

Approval history

Source: Drugs@FDA
Most recent submissions on application 206709.
Type No. Action Status Date Review
Supplement 6 Labeling Approved April 15, 2026 Standard
Supplement 3 Efficacy Approved July 14, 2022 Standard
Original application 1 Type 1 - New Molecular Entity Approved August 20, 2018 Priority

Review documents

  • 0 · Supplement · April 17, 2026
  • 0 · Supplement · April 16, 2026
  • 0 · Supplement · April 16, 2026
  • 0 · Supplement · July 15, 2022
  • 0 · Supplement · July 14, 2022
  • 0 · Original application · September 12, 2018
  • 0 · Original application · August 27, 2018
  • 0 · Original application · August 21, 2018
  • 0 · Original application · August 21, 2018

Adverse event reports

Source: openFDA FAERS
2,141
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: STIRIPENTOL. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
68418-7939-6 68418-7939 BIOCODEX, INC. 1 BOTTLE in 1 CARTON (68418-7939-6) / 60 CAPSULE in 1 BOTTLE August 21, 2018
68418-7940-6 68418-7940 BIOCODEX, INC. 1 BOTTLE in 1 CARTON (68418-7940-6) / 60 CAPSULE in 1 BOTTLE August 21, 2018
68418-7939 68418-7939 BIOCODEX, INC. — August 21, 2018
68418-7940 68418-7940 BIOCODEX, INC. — August 21, 2018

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 11 sections on this page.