Trazodone Hydrochloride Tablet
NDC Package 13668-331-05

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

Trazodone Hydrochloride tablets is classified as a serotonin reuptake inhibitor - [epc] (established pharmacologic class) administered via oral route. This formulation utilizes a tablet delivery system. Marketed by Torrent Pharmaceuticals Limited, this product is identified by NDC 13668-331 and is authorized under FDA application ANDA202180.

Identification & Billing

NDC Package Code
13668-331-05
Package Description
500 TABLET in 1 BOTTLE
Product Code
13668-331
11-Digit Billing Format
13668033105
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
500 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Trazodone Hydrochloride
Non-Proprietary Name
Trazodone Hydrochloride
Substance Name
Trazodone Hydrochloride
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
TRAZODONE HYDROCHLORIDE 100 mg/1
Pharmacologic Class
Serotonin Reuptake Inhibitor - [EPC] (Established Pharmacologic Class)

Regulatory & Marketing

Labeler Name
Torrent Pharmaceuticals Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA202180
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-27-2013
Listing Expiration
12-31-2027
Exclude Flag
N
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 (13668-331). Click a package code to view its specific billing and regulatory data.

13668-331-01
100 TABLET in 1 BOTTLE
13668-331-10
1000 TABLET in 1 BOTTLE
13668-331-30
30 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 13668-331-05 identifies a specific commercial package of 500 tablet in 1 bottle of Trazodone Hydrochloride, a human prescription drug labeled by Torrent Pharmaceuticals Limited. This tablet is formulated for oral use and contains trazodone hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Torrent Pharmaceuticals Limited on November 27, 2013. The current certification is valid through December 31, 2027.

How is this Torrent Pharmaceuticals Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 13668033105. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 500 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)
13668-331-05
11-Digit CMS (5-4-2)
13668-0331-05

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