80425-0302 NDC - TRAZODONE HYDROCHLORIDE

Drug Information

Product NDC: 80425-0302
Proprietary Name: Trazodone Hydrochloride
Non Proprietary Name: Trazodone Hydrochloride
Active Ingredient(s): 150 mg/1 TRAZODONE HYDROCHLORIDE
Administration Route(s): ORAL
Dosage Form(s): TABLET
Pharmacy Class(es): Serotonin Reuptake Inhibitor [EPC]

Labeler Information

Field Name	Field Value
Labeler Name:	Advanced Rx Pharmacy of Tennessee, LLC
Product Type:	HUMAN PRESCRIPTION DRUG
FDA Application Number:	ANDA204852
Marketing Category:	ANDA
Start Marketing Date:	4/10/2023

Package Information

No.	Package Code	Package Description	Billing Unit
1	80425-0302-1	30 TABLET in 1 BOTTLE (80425-0302-1)	EA
2	80425-0302-2	60 TABLET in 1 BOTTLE (80425-0302-2)	EA
3	80425-0302-3	90 TABLET in 1 BOTTLE (80425-0302-3)	EA

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	80425-0302	The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAME	HUMAN PRESCRIPTION DRUG	Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAME	Trazodone Hydrochloride	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAME	Trazodone Hydrochloride	The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAME	TABLET	The translation of the dosage form Code submitted by the firm.
ROUTE NAME	ORAL	The translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE	4/10/2023	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
MARKETING CATEGORY NAME	ANDA	A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard.
APPLICATION NUMBER	ANDA204852	This is the date that the labeler indicates was the start of its marketing of the drug product.
LABELER NAME	Advanced Rx Pharmacy of Tennessee, LLC	This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
SUBSTANCE NAME	TRAZODONE HYDROCHLORIDE	Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
ACTIVE NUMERATOR STRENGTH	150
ACTIVE INGRED UNIT	mg/1
PHARM CLASSES	Serotonin Reuptake Inhibitor [EPC]

Download Record

Download this NDC record record in Text format: Export

Download this NDC record record in Excel (CSV) format: Export

Download this NDC record record in XML format: Export

This page was last updated on: 11/21/2025

Previous Code

Next Code