Clobazam NDC 42571-316

NDC codes

FDA NDC Directory

Product NDC (as listed)42571-316Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42571-0316Add 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
42571-316-01	42571031601	100 TABLET in 1 BOTTLE (42571-316-01)Marketed from Apr 2, 2019
42571-316-11	42571031611	100 BLISTER PACK in 1 CARTON (42571-316-11) / 10 TABLET in 1 BLISTER PACK (42571-316-32)Marketed from Apr 2, 2019
42571-316-30	42571031630	30 TABLET in 1 BOTTLE (42571-316-30)Marketed from Apr 2, 2019
42571-316-90	42571031690	90 TABLET in 1 BOTTLE (42571-316-90)Marketed from Apr 2, 2019
42571-316-91	42571031691	100 BLISTER PACK in 1 CARTON (42571-316-91) / 10 TABLET in 1 BLISTER PACK (42571-316-20)Marketed from Apr 2, 2019

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 — 20 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Micro Labs Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211711
Marketing start: Apr 2, 2019
Listing expires: Dec 31, 2027
DEA schedule: CIV
Other FDA classes: Benzodiazepines (Chemical structure)Cytochrome P450 2D6 Inhibitors (Mechanism)Cytochrome P450 3A4 Inducers (Mechanism)
Identifiers: Product ID 42571-316_50d350cb-6640-b3c2-e063-6394a90a397bSPL ID 50d350cb-6640-b3c2-e063-6394a90a397bSPL set ID 721dde68-db83-4dad-8649-8046cb455372RxCUI 199450, 246172UNII 2MRO291B4UUPC 0342571316013, 0342571315016
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

N442571031601 followed by a unit qualifier and the quantity

Package 42571-0316-01. 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 May 2, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

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

Other NDCs under ANDA 211711

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

FDA NDC Directory listings under ANDA 211711
Product	Strength	Form · route	Labeler	Product NDC
Clobazam	Clobazam 10 mg/1	TabletOral	Micro Labs Limited	42571-315