Trazodone Hydrochloride Tablet
NDC Package 13107-080-01

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 are indicated for the treatment of major depressive disorder (MDD) in adults. This formulation utilizes a tablet delivery system. Marketed by Aurolife Pharma Llc, this product is identified by NDC 13107-080 and is authorized under FDA application ANDA204852.

Identification & Billing

NDC Package Code
13107-080-01
Package Description
100 TABLET in 1 BOTTLE
Product Code
13107-080
11-Digit Billing Format
13107008001
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 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)
Usage Information
Trazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults.

Regulatory & Marketing

Labeler Name
Aurolife Pharma Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA204852
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-15-2015
Listing Expiration
12-31-2026
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 (13107-080). Click a package code to view its specific billing and regulatory data.

13107-080-05
500 TABLET in 1 BOTTLE
13107-080-30
30 TABLET in 1 BOTTLE
13107-080-99
1000 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 13107-080-01 identifies a specific commercial package of 100 tablet in 1 bottle of Trazodone Hydrochloride, a human prescription drug labeled by Aurolife Pharma Llc. 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 Aurolife Pharma Llc on September 15, 2015. The current certification is valid through December 31, 2026.

How is this Aurolife Pharma Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 13107008001. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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)
13107-080-01
11-Digit CMS (5-4-2)
13107-0080-01

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