Lorazepam
NDC Package 53489-357-03

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.

Lorazepam is a medication used to treat anxiety. Marketed by Mutual Pharmaceutical Company, Inc., this product is identified by NDC 53489-357 and is authorized under FDA application ANDA072555.

Identification & Billing

NDC Package Code
53489-357-03
Package Description
250 TABLET in 1 BOTTLE, PLASTIC
Product Code
53489-357
11-Digit Billing Format
53489035703

Clinical Specifications

Proprietary Name
Lorazepam
Dosage Form
-
Usage Information
This medication is used to treat anxiety. Lorazepam belongs to a class of drugs known as 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
Mutual Pharmaceutical Company, Inc.
FDA Application #
ANDA072555
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-29-1991
End Marketing Date
04-30-2010
Listing Expiration
04-30-2010
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 (53489-357). Click a package code to view its specific billing and regulatory data.

53489-357-01
100 TABLET in 1 BOTTLE, PLASTIC
53489-357-02
50 TABLET in 1 BOTTLE, PLASTIC
53489-357-05
500 TABLET in 1 BOTTLE, PLASTIC
53489-357-06
60 TABLET in 1 BOTTLE, PLASTIC
53489-357-10
1000 TABLET in 1 BOTTLE, PLASTIC

* 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 53489-357-03 identifies a specific commercial package of 250 tablet in 1 bottle, plastic of Lorazepam, labeled by Mutual Pharmaceutical Company, 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 Mutual Pharmaceutical Company, Inc. on March 29, 1991. The current certification is valid through April 30, 2010.

What are the primary indications for this medication?

This medication is used to treat anxiety. Lorazepam belongs to a class of drugs known as 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 Mutual Pharmaceutical Company, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53489035703. 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)
53489-357-03
11-Digit CMS (5-4-2)
53489-0357-03

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