Trazodone Hydrochloride
NDC Package 16590-232-71

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.

Trazodone Hydrochloride is tablets are indicated for the treatment of depression. Marketed by Stat Rx Llc Usa, this product is identified by NDC 16590-232 and is authorized under FDA application ANDA071524.

Identification & Billing

NDC Package Code
16590-232-71
Package Description
100 TABLET in 1 BOTTLE
Product Code
16590-232
11-Digit Billing Format
16590023271
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Trazodone Hydrochloride
Dosage Form
-
Usage Information
Trazodone hydrochloride tablets are indicated for the treatment of depression. The efficacy of trazodone HCl has been demonstrated in both inpatient and outpatient settings and for depressed patients with and without prominent anxiety. The depressive illness of patients studied corresponds to the Major Depressive Episode criteria of the American Psychiatric Association’s Diagnostic and Statistical Manual, lll.aMajor Depressive Episode implies a prominent and relatively persistent (nearly every day for at least two weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least four of the following eight symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigability, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and suicidal ideation or attempts.

Regulatory & Marketing

Labeler Name
Stat Rx Llc Usa
FDA Application #
ANDA071524
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-11-1987
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 (16590-232). Click a package code to view its specific billing and regulatory data.

16590-232-15
15 TABLET in 1 BOTTLE
16590-232-28
28 TABLET in 1 BOTTLE
16590-232-30
30 TABLET in 1 BOTTLE
16590-232-60
60 TABLET in 1 BOTTLE
16590-232-90
90 TABLET 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 16590-232-71 identifies a specific commercial package of 100 tablet in 1 bottle of Trazodone Hydrochloride, labeled by Stat Rx Llc Usa. 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 Llc Usa on December 11, 1987. The current certification is valid through December 31, 2017.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 16590023271. 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)
16590-232-71
11-Digit CMS (5-4-2)
16590-0232-71

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