Niravam
NDC Package 16590-938-72

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 inactivated by the FDA.

Niravam is ® is contraindicated in patients with known sensitivity to this drug or other benzodiazepines. Marketed by Stat Rx Usa Llc, this product is identified by NDC 16590-938 and is authorized under FDA application NDA021726.

Identification & Billing

NDC Package Code
16590-938-72
Package Description
120 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE
Product Code
16590-938
11-Digit Billing Format
16590093872
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Niravam
Dosage Form
-
Usage Information
NIRAVAM® is contraindicated in patients with known sensitivity to this drug or other benzodiazepines. NIRAVAM® may be used in patients with open angle glaucoma who are receiving appropriate therapy, but is contraindicated in patients with acute narrow angle glaucoma.NIRAVAM® is contraindicated with ketoconazole and itraconazole, since these medications significantly impair the oxidative metabolism mediated by cytochrome P450 3A (CYP3A) (see CLINICAL PHARMACOLOGY, WARNINGS and PRECAUTIONS–Drug Interactions).

Regulatory & Marketing

Labeler Name
Stat Rx Usa Llc
FDA Application #
NDA021726
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-20-2005
Listing Expiration
12-31-2017
Exclude Flag
I
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 (16590-938). Click a package code to view its specific billing and regulatory data.

16590-938-30
30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE
16590-938-60
60 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE
16590-938-90
90 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 16590-938-72 identifies a specific commercial package of 120 tablet, orally disintegrating in 1 bottle of Niravam, labeled by Stat Rx Usa Llc. 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 Stat Rx Usa Llc on January 20, 2005. The current certification is valid through December 31, 2017.

How is this Stat Rx Usa Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 16590093872. 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)
16590-938-72
11-Digit CMS (5-4-2)
16590-0938-72

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