Clobazam Tablet
NDC Package 72205-047-91

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Clobazam tablets is a medication used with other medications to help control seizures. This formulation utilizes a tablet delivery system. Marketed by Novadoz Pharmaceuticals Llc, this product is identified by NDC 72205-047 and is authorized under FDA application ANDA213404.

Identification & Billing

NDC Package Code
72205-047-91
Package Description
1 BOTTLE in 1 CARTON / 100 TABLET in 1 BOTTLE
Product Code
72205-047
11-Digit Billing Format
72205004791
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Clobazam
Non-Proprietary Name
Clobazam
Substance Name
Clobazam
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
CLOBAZAM 10 mg/1
Pharmacologic Class
Usage Information
This medication is used with other medications to help control seizures. It belongs to a class of medications called benzodiazepines, which act on the brain and nerves (central nervous system) to produce a calming effect. This drug works by enhancing the effects of a certain natural chemical in the body (GABA).
DEA Schedule
Schedule IV (CIV) Substances

Regulatory & Marketing

Labeler Name
Novadoz Pharmaceuticals Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA213404
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-10-2022
Listing Expiration
12-31-2026
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 72205-047-91 identifies a specific commercial package of 1 bottle in 1 carton / 100 tablet in 1 bottle of Clobazam, a human prescription drug labeled by Novadoz Pharmaceuticals Llc. This tablet 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 Novadoz Pharmaceuticals Llc on June 10, 2022. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used with other medications to help control seizures. It belongs to a class of medications called benzodiazepines, which act on the brain and nerves (central nervous system) to produce a calming effect. This drug works by enhancing the effects of a certain natural chemical in the body (GABA).

How is this Novadoz Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72205004791. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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 (5-3-2)
72205-047-91
11-Digit CMS (5-4-2)
72205-0047-91

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