Clobazam NDC 0832-0581

NDC codes

FDA NDC Directory

Product NDC (as listed)0832-0581Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00832-0581Add 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
0832-0581-11	00832058111	100 TABLET in 1 BOTTLE (0832-0581-11)Marketed from Oct 22, 2018

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 20 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Upsher-Smith Laboratories, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209687
Marketing start: Oct 22, 2018
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 0832-0581_1e02d082-c325-6bd1-e063-6294a90a14acSPL ID 1e02d082-c325-6bd1-e063-6294a90a14acSPL set ID 6da2c381-057b-456a-b57b-464f8b383371RxCUI 199450, 246172UNII 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

N400832058111 followed by a unit qualifier and the quantity

Package 00832-0581-11. 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 Jul 24, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

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

Other NDCs under ANDA 209687

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 209687
Product	Strength	Form · route	Labeler	Product NDC
Clobazam	Clobazam 10 mg/1	TabletOral	Golden State Medical Supply, Inc.	51407-585
Clobazam	Clobazam 20 mg/1	TabletOral	Golden State Medical Supply, Inc.	51407-586
Clobazam	Clobazam 10 mg/1	TabletOral	Upsher-Smith Laboratories, LLC	0832-0580