Clobazam Suspension
NDC Package 72162-2608-2

11-digit billing NDC: 72162260802 · Billing unit: ML · 120 ML per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Clobazam suspension is 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. This formulation utilizes a suspension delivery system. Marketed by Bryant Ranch Prepack, this product is identified by NDC 72162-2608 and is authorized under FDA application ANDA214404.

Identification & Billing

NDC Package Code
72162-2608-2
Package Description
1 BOTTLE in 1 CARTON / 120 mL in 1 BOTTLE
Product Code
72162-2608
11-Digit Billing Format
72162260802
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
120 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Clobazam
Non-Proprietary Name
Clobazam
Substance Name
Clobazam
Dosage Form
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
CLOBAZAM 2.5 mg/mL
Pharmacologic Class
Usage Information
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.
DEA Schedule
Schedule IV (CIV) Substances

Regulatory & Marketing

Labeler Name
Bryant Ranch Prepack
Product Type
Human Prescription Drug
FDA Application #
ANDA214404
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-24-2022
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 72162-2608-2 identifies a specific commercial package of 1 bottle in 1 carton / 120 ml in 1 bottle of Clobazam, a human prescription drug labeled by Bryant Ranch Prepack. This product is billed per "ML" milliliter and contains an estimated amount of 120 billable units per package. This suspension is formulated for oral use and contains clobazam as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Bryant Ranch Prepack on March 24, 2022. The current certification is valid through December 31, 2027.

How is this Bryant Ranch Prepack product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72162260802. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 120 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-4-1)
72162-2608-2
11-Digit CMS (5-4-2)
72162-2608-02

Note: The zero is added to the Package segment to maintain the 5-4-2 structure.