Prescription drug · NDA
Onfi (Clobazam) NDC 67386-315
Clobazam 20 mg/1 · Tablet · Oral · Lundbeck Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67386-315-01 | 6738603150167386031501 | 1 BOTTLE in 1 CARTON (67386-315-01) / 100 TABLET in 1 BOTTLEMarketed from Dec 10, 2013 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Onfi
- Generic name (nonproprietary)
- clobazam
- Active ingredients
- Clobazam — 20 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Lundbeck Pharmaceuticals LLCNDC labeler code 67386
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 202067
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Benzodiazepines (Chemical structure)Cytochrome P450 2D6 Inhibitors (Mechanism)Cytochrome P450 3A4 Inducers (Mechanism)
- Identifiers
- Product ID 67386-315_68dbe31c-2dbe-49ad-8b2e-2cf1b8521167SPL ID 68dbe31c-2dbe-49ad-8b2e-2cf1b8521167SPL set ID de03bd69-2dca-459c-93b4-541fd3e9571cRxCUI 199450, 246172, 1191056, 1191058, 1366192, 1366196UNII 2MRO291B4UUPC 0367386314016
- Pharmacologic class
- Benzodiazepine
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
N467386031501followed by a unit qualifier and the quantityPackage 67386-0315-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
ONFI ® (clobazam) is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older. ONFI is a benzodiazepine indicated for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 67386-315
- What is NDC 67386-315?
- 67386-315 is the product NDC for Onfi (clobazam), Clobazam 20 mg/1 tablet, listed with the FDA by Lundbeck Pharmaceuticals LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Onfi (Clobazam).
- What is the active ingredient?
- Clobazam.
- Who is the labeler?
- Lundbeck Pharmaceuticals LLC, NDC labeler code 67386. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Onfi?
- 2 other product NDCs are listed under this name. See all Onfi NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Onfi products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Onficlobazam | Clobazam 10 mg/1 | TabletOral | Lundbeck Pharmaceuticals LLC | 67386-314 | 67386-0314-01 |
| Onficlobazam | Clobazam 2.5 mg/mL | SuspensionOral | Lundbeck Pharmaceuticals LLC | 67386-313 | 67386-0313-21 |
Other NDCs under NDA 202067
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 |
|---|---|---|---|---|
| Onficlobazam | Clobazam 10 mg/1 | TabletOral | Lundbeck Pharmaceuticals LLC | 67386-314 |