Clonazepam
NDC Package 57664-784-86

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

Package Information

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

Clonazepam is used to prevent and control seizures. Marketed by Sun Pharmaceutical Industries, Inc., this product is identified by NDC 57664-784 and is authorized under FDA application ANDA078654.

Identification & Billing

NDC Package Code
57664-784-86
Package Description
60 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE
Product Code
57664-784
11-Digit Billing Format
57664078486
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA

Clinical Specifications

Proprietary Name
Clonazepam
Dosage Form
-
Usage Information
Clonazepam is used to prevent and control seizures. This medication is known as an anticonvulsant or antiepileptic drug. It is also used to treat panic attacks. Clonazepam works by calming your brain and nerves. It belongs to a class of drugs called benzodiazepines.

Regulatory & Marketing

Labeler Name
Sun Pharmaceutical Industries, Inc.
FDA Application #
ANDA078654
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-29-2017
End Marketing Date
12-31-2024
Listing Expiration
12-31-2024
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (57664-784). Click a package code to view its specific billing and regulatory data.

57664-784-83
30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE
57664-784-88
100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE

* 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 57664-784-86 identifies a specific commercial package of 60 tablet, orally disintegrating in 1 bottle of Clonazepam, labeled by Sun Pharmaceutical Industries, 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 Sun Pharmaceutical Industries, Inc. on March 29, 2017. The current certification is valid through December 31, 2024.

What are the primary indications for this medication?

Clonazepam is used to prevent and control seizures. This medication is known as an anticonvulsant or antiepileptic drug. It is also used to treat panic attacks. Clonazepam works by calming your brain and nerves. It belongs to a class of drugs called benzodiazepines.

How is this Sun Pharmaceutical Industries, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 57664078486. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 60 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)
57664-784-86
11-Digit CMS (5-4-2)
57664-0784-86

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