Clobazam NDC 69452-116

NDC codes

FDA NDC Directory

Product NDC (as listed)69452-116Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69452-0116Add 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
69452-116-45	69452011645	1 BOTTLE in 1 CARTON (69452-116-45) / 120 mL in 1 BOTTLEMarketed from Oct 20, 2017

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): Clobazam
Generic name (nonproprietary): clobazam
Active ingredients: Clobazam — 2.5 mg/mL
Dosage form: Suspension
Route: Oral
Labeler: Bionpharma Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208819
Marketing start: Oct 20, 2017
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 69452-116_27d7f38a-1122-d6bb-e063-6394a90a5cd8SPL ID 27d7f38a-1122-d6bb-e063-6394a90a5cd8SPL set ID 4b92ac57-25aa-4c00-b062-dee3944b271bRxCUI 1366192UNII 2MRO291B4U
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

N469452011645 followed by a unit qualifier and the quantity

Package 69452-0116-45. 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 Dec 3, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Clobazam oral suspension is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older. Clobazam 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)