Clobazam
NDC Package 16729-445-01

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Clobazam is a medication used with other medications to help control seizures. Marketed by Accord Healthcare Inc., this product is identified by NDC 16729-445 and is authorized under FDA application ANDA212398.

Identification & Billing

NDC Package Code
16729-445-01
Package Description
100 TABLET in 1 BOTTLE
Product Code
16729-445
11-Digit Billing Format
16729044501

Clinical Specifications

Proprietary Name
Clobazam
Dosage Form
-
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).

Regulatory & Marketing

Labeler Name
Accord Healthcare Inc.
FDA Application #
ANDA212398
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-15-2024
End Marketing Date
08-15-2024
Listing Expiration
08-15-2024
Exclude Flag
D
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 16729-445-01 identifies a specific commercial package of 100 tablet in 1 bottle of Clobazam, labeled by Accord Healthcare Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Accord Healthcare Inc. on August 15, 2024. The current certification is valid through August 15, 2024.

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 Accord Healthcare Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 16729044501. 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)
16729-445-01
11-Digit CMS (5-4-2)
16729-0445-01

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