Prescription drug · NDA
Diacomit (Stiripentol) NDC 68418-7940
Stiripentol 500 mg/1 · Capsule · Oral · BIOCODEX, INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68418-7940-6 | 68418794006 | 1 BOTTLE in 1 CARTON (68418-7940-6) / 60 CAPSULE in 1 BOTTLEMarketed 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
- Capsule
- Route
- Oral
- Labeler
- BIOCODEX, INC.NDC labeler code 68418
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 206709
- Marketing start
- Listing expires
- Identifiers
- Product ID 68418-7940_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
N468418794006followed by a unit qualifier and the quantityPackage 68418-7940-06. 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 .
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.
About NDC 68418-7940
- What is NDC 68418-7940?
- 68418-7940 is the product NDC for Diacomit (stiripentol), Stiripentol 500 mg/1 capsule, listed with the FDA by BIOCODEX, INC.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Diacomit (Stiripentol).
- What is the active ingredient?
- Stiripentol.
- Who is the labeler?
- BIOCODEX, INC., NDC labeler code 68418. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Diacomit?
- 3 other product NDCs are listed under this name. See all Diacomit NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Diacomit products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Diacomitstiripentol | Stiripentol 250 mg/1 | CapsuleOral | BIOCODEX, INC. | 68418-7939 | 68418-7939-06 |
| Diacomitstiripentol | Stiripentol 250 mg/1 | Powder, For suspensionOral | BIOCODEX, INC. | 68418-7941 | 68418-7941-06 |
| Diacomitstiripentol | Stiripentol 500 mg/1 | Powder, For suspensionOral | BIOCODEX, INC. | 68418-7942 | 68418-7942-06 |
Other NDCs under NDA 206709
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Diacomitstiripentol | Stiripentol 250 mg/1 | CapsuleOral | BIOCODEX, INC. | 68418-7939 |