Onfi (clobazam) NDC 67386-313

NDC codes

FDA NDC Directory

Product NDC (as listed)67386-313Labeler and product segments. Claims need a package NDC.

Product NDC at billing width67386-0313Add 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
67386-313-21	67386031321	1 BOTTLE in 1 CARTON (67386-313-21) / 120 mL in 1 BOTTLEMarketed from Dec 14, 2012

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 — 2.5 mg/mL
Dosage form: Suspension
Route: Oral
Labeler: Lundbeck Pharmaceuticals LLC
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 203993
Marketing start: Dec 14, 2012
Listing expires: Dec 31, 2026
DEA schedule: CIV
Other FDA classes: Benzodiazepines (Chemical structure)Cytochrome P450 2D6 Inhibitors (Mechanism)Cytochrome P450 3A4 Inducers (Mechanism)
Identifiers: Product ID 67386-313_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

N467386031321 followed by a unit qualifier and the quantity

Package 67386-0313-21. 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 Mar 12, 2024. 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.

Full label on DailyMed (opens in a new tab)