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TRAZODONE HYDROCHLORIDE 100 mg Tablet, 90-count

by Bryant Ranch Prepack · 90 TABLET in 1 BOTTLE (72162-2531-9)

NDC 72162-2531-09

🏷️ FDA NDC (as labeled) 72162-2531-9 billing pads the package segment with a zero

This package

Contains90-count Pack sizes5 compare ↓

Also priced by: Part D plans $0.2383/unit — full pricing hub ↓

Also comes in: 30 tablets 72162-2531-03 100 tablets 72162-2531-01 500 tablets 72162-2531-05 1000 tablets 72162-2531-00

Rx only Generic On market Non-controlled

🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm

📋 All sources & update times →

This page is curated, coded, and maintained by Dr. Brian Staiger, PharmD

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️

Other active recalls for Trazodone Hydrochloride (different manufacturers) — 2 · tap to view

These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.

Class II · Jan 26, 2026 — Presence of Foreign Tablets/Capsules (Granules Pharmaceuticals Inc.) · FDA recall D-0305-2026

Class III · Dec 19, 2025 — Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface. (Zydus Pharmaceuticals (USA) Inc) · FDA recall D-0247-2026

Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 72162-2531-9

Product NDC 72162-2531

11-digit billing NDC 72162253109

NCPDP billing unit EA — each (per item)

RxCUI 856373

UNII 6E8ZO8LRNM

Application # ANDA204852

SPL Set ID 4370fe5c-1c40-499b-abb5-bca0a39834c6

Established class (EPC) Serotonin Reuptake Inhibitor

DEA schedule Non-controlled

Marketing category ANDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2015-09-15

Route ORAL

Dosage form TABLET

Substance TRAZODONE HYDROCHLORIDE

GCN Seq No 046242

GCN 16392

HICL code 001652

Ingredient (HICL) Trazodone Hcl

HIC1 code H

Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)

HIC2 code H7

Therapeutic class — intermediate (HIC2) Psychoactive Drugs (Continued 1)

HIC3 code H7E

Therapeutic class — specific (HIC3) Serotonin-2 Antagonist/Reuptake Inhibitors (Saris)

AHFS code 28:16.04.24

AHFS class Serotonin Modulators

FDB label name TRAZODONE 100 MG TABLET

FDB brand name Trazodone Hcl

Legend status F — Federal legend — prescription drug or device

TE code (Orange Book) AB · RLD · RS

Why two NDCs? The FDA registers this code as 72162-2531-9 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 72162-2531-09. Same drug, same package — only the format differs.

Where does this data come from?

Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Serotonin Reuptake Inhibitor class.

Pharmacologic class Serotonin Reuptake Inhibitor

Drug family (ATC) Other antidepressants

Where does this data come from?

Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerBryant Ranch Prepack

Application holderAUROBINDO PHARMA LTD

FDA applicationANDA204852 (ANDA)

Labeler code72162

First marketedSep 2015

Product typeHuman Prescription Drug

Portfolio4,433 products on file

🔎 All NDCs from Bryant Ranch Prepack

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).

Where does this data come from?

Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name TRAZODONE 100 MG TABLET Ingredient Trazodone Hcl

📖 What it is MedlinePlus · NLM

Trazodone is used to treat depression. Trazodone is in a class of medications called serotonin modulators. It works by increasing the amount of serotonin, a natural substance in the brain that helps maintain mental balance.

Read the full MedlinePlus article ↗

📗 Our plain-language guide HelloPharmacist

Trazodone is FDA-approved to treat major depressive disorder (MDD) in adults. It's an antidepressant that works by boosting serotonin activity in the brain. It comes as tablets (Tr...
Always take it with food — shortly after a meal or a light snack. Food helps your body absorb it properly and can reduce the chance of stomach upset. Taking it on an empty stomach...
Should I take trazodone with food or on an empty stomach?
Yes, drowsiness is one of the most common side effects. If it's bothering you during the day, talk to your prescriber — they may shift most of your dose to bedtime, which can actua...

📖 Read our full Trazodone guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →

Nutrient depletion considerations

Trazodone may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

SODIUM Moderate Depletion

🧪 Full Trazodone nutrient depletion report →

An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.

Where does this data come from?

Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color White

ShapeRound

ImprintJ;44

Size1 mm

ScoringScored — splits in 2

One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.

Where does this data come from?

Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
UNII 368GB5141J
A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
UNII 5856J3G2A2
A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.

6 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?

Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price system	Per each	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo	No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026	$0.2383	$21.45 / 90 tablets

Where does this data come from?

NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Trazodone Hydrochloride 100 mg 16729-0300-01	Accord	100 tablets	$0.050	AB	Availability likely	—
Trazodone Hydrochloride 100 mg 00904-6869-61	Major	100 tablets	$0.051	AB	Availability likely	—
Trazodone Hydrochloride 100 mg 13107-0080-01	Aurolife	100 tablets	$0.051	AB	Availability likely	—
Trazodone Hydrochloride 100 mg 13668-0331-01	Torrent	100 tablets	$0.051	AB	Availability likely	—
Trazodone Hydrochloride 100 mg 50111-0561-01	Teva	100 tablets	$0.051	AB	Availability likely	—
Trazodone Hydrochloride 100 mg 57664-0026-72	Sun	100 tablets	$0.051	AB	Availability likely	—
Trazodone Hydrochloride 100 mg 60687-0454-01	American	100 tablets	$0.051	AB	Availability likely	—
Trazodone Hydrochloride 100 mg 64980-0673-01	Rising	100 tablets	$0.051	AB	Availability likely	—
Trazodone Hydrochloride 100 mg 68382-0610-01	Zydus	100 tablets	$0.051	AB	Availability likely	—
Trazodone Hydrochloride 100 mg 68382-0806-01	Zydus	100 tablets	$0.051	AB	Availability likely	—
Trazodone Hydrochloride 100 mg 70010-0232-01	Granules	100 tablets	$0.051	AB	Availability likely	—
Trazodone Hydrochloride 100 mg 00615-8386-05	NCS	15 tablets	—	AB	FDA listed	—
Trazodone Hydrochloride 100 mg 42291-0869-10	AvKARE	1000 tablets	—	AB	FDA listed	—
Trazodone Hydrochloride 100 mg 45865-0505-60	Medsource	60 tablets	—	AB	FDA listed	—
Trazodone Hydrochloride 100 mg 50090-4283-00	A-S	30 tablets	—	AB	FDA listed	—
Trazodone Hydrochloride 100 mg 50090-6723-00	A-S	90 tablets	—	AB	FDA listed	—
Trazodone Hydrochloride 100 mg 51407-0947-01	Golden	100 tablets	—	AB	FDA listed	—
Trazodone Hydrochloride 100 mg 51655-0986-26	Northwind	90 tablets	—	AB	FDA listed	—
Trazodone Hydrochloride 100 mg 55154-8085-00	Cardinal	10 tablets	—	AB	FDA listed	—
Trazodone Hydrochloride 100 mg 60505-2654-00	Apotex	100 tablets	—	AB	FDA listed	—
Trazodone Hydrochloride 100 mg 60760-0806-30	St.	30 tablets	—	AB	Discontinued	—
Trazodone Hydrochloride 100 mg 67046-1540-03	Coupler	30 tablets	—	AB	FDA listed	—
Trazodone Hydrochloride 100 mg 67046-1662-03	Coupler	30 tablets	—	AB	FDA listed	—
Trazodone Hydrochloride 100 mg 68071-2959-03	NuCare	30 tablets	—	AB	FDA listed	—
Trazodone Hydrochloride 100 mg 68071-4761-03	NuCare	30 tablets	—	AB	FDA listed	—
Trazodone Hydrochloride 100 mg 68071-4833-01	NuCare	100 tablets	—	AB	FDA listed	—
Trazodone Hydrochloride 100 mg 68788-7137-01	Preferred	100 tablets	—	AB	FDA listed	—
Trazodone Hydrochloride 100 mg 69584-0885-10	Oxford	100 tablets	—	AB	FDA listed	—
Trazodone Hydrochloride 100 mg 70518-1204-02	REMEDYREPACK	30 tablets	—	AB	Discontinued	—
Trazodone Hydrochloride 100 mg 70518-2973-00	REMEDYREPACK	30 tablets	—	AB	FDA listed	—
Trazodone Hydrochloride 100 mg 70518-3403-00	REMEDYREPACK	100 tablets	—	AB	Discontinued	—
Trazodone Hydrochloride 100 mg 70518-3426-00	REMEDYREPACK	30 tablets	—	AB	Discontinued	—
Trazodone Hydrochloride 100 mg 70518-3756-00	REMEDYREPACK	30 tablets	—	AB	FDA listed	—
Trazodone Hydrochloride 100 mg 70771-1129-00	Zydus	1000 tablets	—	AB	FDA listed	—
Trazodone Hydrochloride 100 mg 70771-1939-00	Zydus	1000 tablets	—	AB	FDA listed	—
Trazodone Hydrochloride 100 mg 71205-0574-30	Proficient	30 tablets	—	AB	FDA listed	—
Trazodone Hydrochloride 100 mg 71205-0630-30	Proficient	30 tablets	—	AB	FDA listed	—
Trazodone Hydrochloride 100 mg 71335-0730-01	Bryant	30 tablets	—	AB	FDA listed	—
Trazodone Hydrochloride 100 mg 71335-3022-02	Bryant	30 tablets	—	AB	FDA listed	—
Trazodone Hydrochloride 100 mg 71335-3023-01	Bryant	500 tablets	—	AB	FDA listed	—
Trazodone Hydrochloride 100 mg 71335-3041-01	Bryant	100 tablets	—	AB	FDA listed	—
Trazodone Hydrochloride 100 mg 71335-3098-01	Bryant	30 tablets	—	AB	FDA listed	—
Trazodone Hydrochloride 100 mg 71610-0511-30	Aphena	30 tablets	—	AB	FDA listed	—
Trazodone Hydrochloride 100 mg 71610-0513-30	Aphena	30 tablets	—	AB	FDA listed	—
Trazodone Hydrochloride 100 mg 71610-0530-30	Aphena	30 tablets	—	AB	FDA listed	—
Trazodone Hydrochloride 100 mg 71610-0537-30	Aphena	30 tablets	—	AB	FDA listed	—
Trazodone Hydrochloride 100 mgthis 72162-2531-09	Bryant	90 tablets	—	AB	FDA listed	—
Trazodone Hydrochloride 100 mg 72789-0168-30	PD-Rx	30 tablets	—	AB	FDA listed	—
Trazodone Hydrochloride 100 mg 72789-0424-30	PD-Rx	30 tablets	—	AB	FDA listed	—
Trazodone Hydrochloride 100 mg 76420-0648-01	Asclemed	100 tablets	—	AB	FDA listed	—
Trazodone Hydrochloride 100 mg 80425-0298-01	Advanced	30 tablets	—	AB	FDA listed	—
Trazodone Hydrochloride 100 mg 71335-1630-01	Bryant	30 tablets	—	AB	FDA listed	—
Trazodone Hydrochloride 100 mg 87441-0080-01	Unit	30 tablets	—	AB	FDA listed	—
Trazodone Hydrochloride 100 mg 72789-0588-90	PD-Rx	90 tablets	—	AB	FDA listed	—
Trazodone Hydrochloride 100 mg 70518-4737-00	REMEDYREPACK	90 tablets	—	AB	FDA listed	—

About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.

Where does this data come from?

Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️

2015

On the market since

Sep 2015

📍

2026

Currently FDA-listed

11 years listed

🔓

Generic on the market

this product is a generic

✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?

Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Trazodone Hydrochloride — the ingredient across all brands.

Top reported reactions

Fatigue1,157

Nausea1,124

Headache924

Pain823

Diarrhoea817

Vomiting707

Insomnia695

Age at onset

Neonate10

Infant1

Child11

Adolescent18

Adult1,712

Elderly1,020

Reporter sex

Male · 34%

Female · 66%

Unknown · 0%

Serious outcomes

Death1,594

Life-threatening655

Disabling455

Reports over time (by year) — tap or hover for the count & year

Most recent year is provisional (FAERS lags ~3 months).

Where does this data come from?

Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
72162-2531-00	1000 TABLET in 1 BOTTLE (72162-2531-0)	2025-09-19	Active
72162-2531-01	100 TABLET in 1 BOTTLE (72162-2531-1)	2025-09-19	Active
72162-2531-03	30 TABLET in 1 BOTTLE (72162-2531-3)	2025-09-19	Active
72162-2531-05	500 TABLET in 1 BOTTLE (72162-2531-5)	2025-09-19	Active
72162-2531-09 You're viewing this	90 TABLET in 1 BOTTLE (72162-2531-9)	2025-09-19	Active

You're viewing one of 5 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 72162-2531-09?

NDC 72162-2531-09 is a 90-count package — 90 tablet in 1 bottle.

What is the difference between NDC 72162-2531-09 and NDC 72162-2531-03?

Both are TRAZODONE HYDROCHLORIDE 100 mg Tablet — the drug itself is identical. NDC 72162-2531-09 is the 90-count package, while NDC 72162-2531-03 is the 30 tablets package.

What NDC number is used to bill for this package of TRAZODONE HYDROCHLORIDE 100 mg Tablet?

Bill NDC 72162-2531-09 — the 11-digit billing format is 72162253109. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product

What data is (and isn’t) available for this NDC — tap to expand

NDC identity (package / product / labeler codes)	✓ Available
Labeler	✓ Available
Product & package description	✓ Available
Marketing category & status	✓ Available
Active ingredient / dosage form / route	✓ Available
FDA label (SPL via DailyMed)	✓ Available
Package photos	✓ Available
Inactive ingredients (structured)	✓ Available
NADAC pharmacy acquisition price (CMS)	— Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data	✓ Available
HCPCS J-code billing crosswalk	— Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD)	— Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.

“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?

The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.

Is the NDC printed on the package the same as the 11-digit billing NDC?

Yes, they identify this exact package in different formats. The FDA registers it as 72162-2531-9, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 72162-2531-09, written without dashes as 72162253109. The Identity section at the top of this page lists every form of this code.

What do the three segments of this NDC mean?

In 72162-2531-09, the first segment (72162) is the labeler code FDA assigned to Bryant Ranch Prepack; the middle segment (2531) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (09) identifies this exact package size and type. Together they name one specific package of one specific product.

Is this package still being marketed?

Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Bryant Ranch Prepack. Listing status can change — the directory data on this page refreshes weekly.

Does this product come in other package sizes?

Yes — the FDA directory lists 4 other package presentations of this same product, including 30 tablets (72162-2531-03), 100 tablets (72162-2531-01), 500 tablets (72162-2531-05). Each has its own NDC and its own page — see the package list near the top of this page.

Who lists this product with the FDA?

Bryant Ranch Prepack is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.

Do I need a prescription for this product?

This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.

This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.

Where does this data come from?

Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.

🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide

🚨 Boxed Warning 124 words ▾

WARNING: SUICIDAL THOUGHTS and BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [ see Warnings and Precautions (5.1) ]. Trazodone Hydrochloride Tablets are not approved for use in pediatric patients [see Use in Specific Populations (8.4) ].

WARNING: SUICIDAL THOUGHTS and BEHAVIORS See full prescribing information for complete boxed warning. Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients ( 5.1 ) Closely monitor for clinical worsening and emergence of suicidal thoughts and behaviors ( 5.1 ) Trazodone Hydrochloride Tablets are not approved for use in pediatric patients ( 8.4 )

🎯 Indications and Usage 40 words ▾

1 INDICATIONS AND USAGE Trazodone Hydrochloride Tablets are indicated for the treatment of major depressive disorder (MDD) in adults. Trazodone Hydrochloride Tablets are a selective serotonin reuptake inhibitor indicated for the treatment of major depressive disorder (MDD) ( 1 ).

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION Starting dose: 150 mg in divided doses daily. May be increased by 50 mg per day every three to four days. Maximum dose: 400 mg per day in divided doses ( 2 ). Trazodone Hydrochloride Tablets should be taken shortly after a meal or light snack ( 2 ). Tablets should be swallowed whole or broken in half along the score line, and should not be chewed or crushed ( 2 ). When discontinued, gradual dose reduction is recommended ( 2 ).

2.1Dose Selection An initial dose of 150 mg/day in divided doses is suggested. The dosage should be initiated at a low-dose and increased gradually, noting the clinical response and any evidence of intolerance. Occurrence of drowsiness may require the administration of a major portion of the daily dose at bedtime or a reduction of dosage.

The dose may be increased by 50 mg/day every 3 to 4 days. The maximum dose for outpatients usually should not exceed 400 mg/day in divided doses. Inpatients (i.e., more severely depressed patients) may be given up to but not in excess of 600 mg/day in divided doses.

Once an adequate response has been achieved, dosage may be gradually reduced, with subsequent adjustment depending on therapeutic response.

2.2Important Administration Instructions Trazodone Hydrochloride Tablets can be swallowed whole or administered as a half tablet by breaking the tablet along the score line. Trazodone Hydrochloride Tablets should be taken shortly after a meal or light snack.

2.3Screen for Bipolar Disorder Prior to Starting Trazodone Hydrochloride Tablets Prior to initiating treatment with Trazodone Hydrochloride Tablets or another antidepressant, screen patients for a personal or family history of bipolar disorder, mania, or hypomania [see Warnings and Precautions (5.7) ].

2.4Switching to or from Monoamine Oxidase Inhibitor Antidepressant At least 14 days must elapse between discontinuation of a monoamine oxidase inhibitor (MAOI) antidepressant and initiation of Trazodone Hydrochloride Tablets. In addition, at least 14 days must elapse after stopping Trazodone Hydrochloride Tablets before starting an MAOI antidepressant [see Contraindications (4) , Warnings and Precautions (5.2) ].

2.5Dosage Recommendations for Concomitant Use with Strong CYP3A4 Inhibitors or Inducers Coadministration with Strong CYP3A4 Inhibitors Consider reducing Trazodone Hydrochloride Tablets dose based on tolerability when Trazodone Hydrochloride Tablets are coadministered with a strong CYP3A4 inhibitor [see Drug Interactions (7.1) ]. Coadministration with Strong CYP3A4 Inducers Consider increasing Trazodone Hydrochloride Tablets dose based on therapeutic response when Trazodone Hydrochloride Tablets are coadministered with a strong CYP3A4 inducer [see Drug Interactions (7.1) ].

2.6Discontinuation of Treatment with Trazodone Hydrochloride Tablets Adverse reactions may occur upon discontinuation of Trazodone Hydrochloride Tablets [See Warnings and Precautions (5.8) ]. Gradually reduce the dosage rather than stopping Trazodone Hydrochloride Tablets abruptly whenever possible.

💊 Dosage Forms and Strengths 169 words ▾

3 DOSAGE FORMS AND STRENGTHS Trazodone hydrochloride tablets USP are available in the following strengths: 50 mg: White to off-white, round, biconvex, uncoated tablets, debossed with ‘J’ and ‘43’ on either side of scoreline (functional) on one side and plain on the other side. 100 mg: White to off-white, round, biconvex, uncoated tablets, debossed with ‘J’ and ‘44’ on either side of scoreline (functional) on one side and plain on the other side. 150 mg: White to off-white, oval, flat faced, beveled-edge, uncoated tablets with one side scored (functional) with full bisect debossed with ‘J’ and ‘45’ on either side and having two partial trisect on one side and plain on the other side.

300 mg: White to off-white, oval, flat faced, beveled-edge, uncoated tablets with one side scored (functional) with full bisect debossed with ‘J’ and ‘46’ on either side and having two partial trisect on one side and plain on the other side. Scored tablets: 50 mg, 100 mg, 150 mg and 300 mg ( 3 ).

⛔ Contraindications 65 words ▾

4 CONTRAINDICATIONS Trazodone Hydrochloride Tablets are contraindicated in: Patients taking, or within 14 days of stopping, monoamine oxidase inhibitors (MAOIs), including MAOIs such as linezolid or intravenous methylene blue, because of an increased risk of serotonin syndrome [see Warnings and Precautions (5.2) , Drug Interactions (7.1) ]. Concomitant use of monoamine oxidase inhibitors (MAOIs), or use within 14 days of stopping MAOIs ( 4 ).

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents (e.g., SSRI, SNRI, triptans), but also when taken alone. If it occurs, discontinue Trazodone Hydrochloride Tablets and initiate supportive treatment ( 5.2 ). Cardiac Arrhythmias: Increases the QT interval.

Avoid use with drugs that also increase the QT interval and in patients with risk factors for prolonged QT interval ( 5.3 ) Orthostatic Hypotension and Syncope: Warn patients of risk and symptoms of hypotension ( 5.4 ). Increased Risk of Bleeding: Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), other antiplatelet drugs, warfarin, and other anticoagulants may increase this risk ( 5.5 ). Priapism: Cases of painful and prolonged penile erections and priapism have been reported.

Immediate medical attention should be sought if signs and symptoms of prolonged penile erections or priapism are observed ( 5.6 ). Activation of Mania or Hypomania: Screen for bipolar disorder and monitor for mania or hypomania ( 5.7 ). Potential for Cognitive and Motor Impairment: Has potential to impair judgment, thinking, and motor skills.

Advise patients to use caution when operating machinery ( 5.9 ). Angle-Closure Glaucoma: Avoid use of antidepressants, including Trazodone Hydrochloride Tablets, in patients with untreated anatomically narrow angles. ( 5.10 ).

5.1Suicidal Thoughts and Behaviors in Pediatric and Young Adult Patients In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included approximately 77,000 adult patients and over 4,400 pediatric patients, the incidence of suicidal thoughts and behaviors in pediatric and young adult patients was greater in antidepressant-treated patients than in placebo-treated patients. The drug-placebo differences in the number of cases of suicidal thoughts and behaviors per 1000 patients treated are provided in Table 1.

No suicides occurred in any of the pediatric studies. There were suicides in the adult studies, but the number was not sufficient to reach any conclusion about antidepressant drug effect on suicide. Table 1: Risk Differences of the Number of Cases of Suicidal Thoughts or Behaviors in the Pooled Placebo-Controlled Age Range (years) Drug-Placebo Difference in Number of Patients of Suicidal Thoughts or Behaviors per 1000 Patients Treated Increases Compared to Placebo <18 14 additional patients 18-24 5 additional patients Decreases Compared to Placebo 25-64 1 fewer patient ≥65 6 fewer patients It is unknown whether the risk of suicidal thoughts and behaviors in pediatric and young adult patients extends to longer-term use, i.e., beyond four months.

However, there is substantial evidence from placebo-controlled maintenance trials in adults with MDD that antidepressants delay the recurrence of depression. Monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy and at times of dosage changes. Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare provider.

Consider changing the therapeutic regimen, including possibly discontinuing Trazodone Hydrochloride Tablets, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors.

5.2Serotonin Syndrome Serotonin-norepinephrine reuptake inhibitors (SNRIs) and SSRIs, including Trazodone Hydrochloride Tablets, can precipitate serotonin syndrome, a potentially life-threatening condition. The risk is increased with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John’s Wort) and with drugs that impair metabolism of serotonin, i.e., MAOIs [see Contraindications (4) , Drug Interactions (7.1) ].

Serotonin syndrome can also occur wh…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Suicidal Thoughts and Behavior in Children, Adolescents and Young Adults [see Boxed Warning and Warnings and Precautions (5.1) ] Serotonin Syndrome [see Warnings and Precautions (5.2) ] Cardiac Arrythmias [see Warnings and Precautions (5.3) ] Orthostatic Hypotension and Syncope [see Warnings and Precautions (5.4) ] Increased Risk of Bleeding [see Warnings and Precautions (5.5) ] Priapism [see Warnings and Precautions (5.6) ] Activation of Mania or Hypomania [see Warnings and Precautions (5.7) ] Discontinuation Syndrome [see Warnings and Precautions (5.8) ] Potential for Cognitive and Motor Impairment [see Warnings and Precautions (5.9) ] Angle-Closure Glaucoma [see Warnings and Precautions (5.10) ] Hyponatremia [see Warnings and Precautions (5.11) ] Most common adverse reactions (incidence ≥ 5% and twice that of placebo) are: edema, blurred vision, syncope, drowsiness, fatigue, diarrhea, nasal congestion, weight loss ( 6 ).

To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Table 2: Common Adverse Reactions Occurring in ≥ 2% of Trazodone Hydrochloride Tablets-treated Patients and Greater than the Rate of Placebo-Treated Patients as Observed in Controlled Clinical Studies Inpatients Outpatients Trazodone Hydrochloride Tablets N=142 Placebo N=95 Trazodone Hydrochloride Tablets N=157 Placebo N=158 Allergic Skin Condition/Edema 3% 1% 7% 1% Autonomic Blurred Vision 6% 4% 15% 4% Constipation 7% 4% 8% 6% Dry Mouth 15% 8% 34% 20% Cardiovascular Hypertension 20% 1% 1% * Hypotension 7% 1% 4% 0 Syncope 3% 2% 5% 1% CNS Confusion 5% 0 6% 8% Decreased Concentration 3% 2% 1% 0 Disorientation 2% 0 * 0 Fatigue 11% 4% 6% 3% Headache 10% 5% 20% 16% Nervousness 15% 11% 6% 8% Gastrointestinal Abdominal/Gastric Disorder 4% 4% 6% 4% Diarrhea 0 1% 5% 1% Nausea/Vomiting 10% 1% 13% 10% Musculoskeletal Aches/Pains 6% 3% 5% 3% Neurological Incoordination 5% 0 2% * Tremors 3% 1% 5% 4% Other Eyes Red/Tired/Itching 3% 0 0 0 Head Full-Heavy 3% 0 0 0 Malaise 3% 0 0 0 Nasal/Sinus Congestion 3% 0 6% 3% Weight Gain 1% 0 5% 2% Weight Loss * 3% 6% 3% Other adverse reactions occurring at an incidence of <2% with the use of trazodone hydrochloride in the controlled clinical studies: akathisia, allergic reaction, anemia, chest pain, delayed urine flow, early menses, flatulence, hallucinations/delusions, hematuria, hypersalivation, hypomania, impaired memory, impaired speech, impotence, increased appetite, increased libido, increased urinary frequency, missed periods, muscle twitches, numbness, paresthesia, retrograde ejaculation, shortness of breath, and tachycardia/palpitations.

Occasional sinus bradycardia has occurred in long-term studies.

6.2Post marketing Experience The following adverse reactions have been identified during post-approval use of Trazodone Hydrochloride Tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or establish a causal relationship to drug exposure: Blood and lymphatic system disorders: hemolytic anemia, leukocytosis Cardiac disorders: cardio spasm, congestive heart failure, conduction block, orthostatic hypotension and syncope, palpitations, bradycardia, atrial fibrillation, myocardial infarction, cardiac arrest, arrhythmia, ventricular ectopic activity, including ventricular tachycardia and QT prolongation.

Prolonged QT interval, torsade de pointes, and ventricular tachycardia have been reported at doses of 100 mg per day or less [see Warnings and Precautions (5.3…

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS CNS Depressants: Trazodone Hydrochloride Tablets may enhance effects of alcohol, barbiturates, or other CNS depressants ( 7 ). CYP3A4 Inhibitors: Consider Trazodone Hydrochloride Tablets dose reduction based on tolerability ( 2.5 , 7 ). CYP3A4 Inducers: Increase in Trazodone Hydrochloride Tablets dosage may be necessary ( 2.5 , 7 ).

Digoxin or Phenytoin: Monitor for increased digoxin or phenytoin serum levels ( 7 ). Warfarin: Monitor for increased or decreased prothrombin time ( 7 ).

7.1Drugs Having Clinically Important Interactions With Trazodone Hydrochloride Tablets Table 3: Clinically Important Drug Interactions with Trazodone Hydrochloride Tablets Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: The concomitant use of MAOIs and serotonergic drugs including Trazodone hydrochloride tablets increases the risk of serotonin syndrome. Intervention: Trazodone hydrochloride tablets are contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue [see Contraindications (4) , Dosage and Administration (2.3 , 2.4) , and Warnings and Precautions (5.2) ].

Examples: isocarboxazid, moclobemide, phenelzine, selegiline, tranylcypromine Other Serotonergic Drugs Clinical Impact: The concomitant use of serotonergic drugs including Trazodone hydrochloride tablets and other serotonergic drugs increases the risk of serotonin syndrome. Intervention: Monitor patients for signs and symptoms of serotonin syndrome, particularly during Trazodone hydrochloride tablets initiation. If serotonin syndrome occurs, consider discontinuation of Trazodone hydrochloride tablets and/or concomitant serotonergic drugs [see Warnings and Precautions (5.2) ].

Examples: triptans, antidepressants (tricyclic and serotonin uptake inhibitors), fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John's Wort Antiplatelet Agents and Anticoagulants Clinical Impact: Serotonin release by platelets plays an important role in hemostasis. The concurrent use of an antiplatelet agent or anticoagulant with Trazodone hydrochloride tablets may potentiate the risk of bleeding.

Intervention: Inform patients of the increased risk of bleeding with the concomitant use of Trazodone hydrochloride tablets and antiplatelet agents and anticoagulants. For patients taking warfarin, carefully monitor the international normalized ratio (INR) when initiating or discontinuing Trazodone hydrochloride tablets [see Warnings and Precautions (5.5) ]. Examples: warfarin, rivaroxaban, dabigatran, clopidogrel Strong CYP3A4 Inhibitors Clinical Impact: The concomitant use of Trazodone hydrochloride tablets and strong CYP3A4 inhibitors increased the exposure of trazodone compared to the use of Trazodone hydrochloride tablets alone.

Intervention: If Trazodone hydrochloride tablets are used with a potent CYP3A4 inhibitor, the risk of adverse reactions, including cardiac arrhythmias, may be increased and a lower dose of Trazodone hydrochloride tablets should be considered [see Dosage and Administration (2.5) , Warnings and Precautions (5.3) ]. Examples: itraconazole, ketoconazole, clarithromycin, indinavir Strong CYP3A4 Inducers Clinical Impact: The concomitant use of Trazodone hydrochloride tablets and strong CYP3A4 inducers decreased the exposure of trazodone compared to the use of Trazodone hydrochloride tablets alone.

Intervention: Patients should be closely monitored to see if there is a need for an increased dose of Trazodone hydrochloride tablets when taking CYP3A4 inducers [see Dosage and Administration (2.5) ]. Examples: rifampin, carbamazepine, phenytoin, St. John’s wort Digoxin and Phenytoin Clinical Impact: Digoxin and phenytoin are narrow therapeutic index drugs.

Concomitant use of Trazodone hydrochloride tablets can increase digoxin or phenytoin concentrations. Intervention: Measure serum digoxin or phenytoin concentrations before initiating concomitant use of Trazodone hydrochloride tablets. Continue monitoring and reduce…

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405- 6185 or visiting online at https://womensmentalhealth.org/clinical-and-research programs/pregnancy registry/antidepressants/ Risk Summary Published prospective cohort studies, case series, and case reports over several decades with Trazodone Hydrochloride Tablets use in pregnant women have not identified any drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data).

Trazodone hydrochloride has been shown to cause increased fetal resorption and other adverse effects on the fetus in the rat when given at dose levels approximately 7.3 to 11 times the maximum recommended human dose (MRHD) of 400 mg/day in adults on a mg/m 2 basis. There was also an increase in congenital anomalies in the rabbit at approximately 7.3 to 22 times the MRHD on a mg/m 2 basis (see Data). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo fetal risk A prospective, longitudinal study followed 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants at the beginning of pregnancy.

The women who discontinued antidepressants during pregnancy were more likely to experience a relapse of major depression that women who continued antidepressants. Consider the risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum. Data Human Data While available studies cannot definitively establish the absence of risk, published data from prospective cohort studies, case series, and case reports over several decades have not identified an association with trazodone use during pregnancy and major birth defects, miscarriage, or other adverse maternal or fetal outcomes.

All available studies have methodological limitations, including small sample size and inconsistent comparator groups. Animal Data No teratogenic effects were observed when trazodone was given to pregnant rats and rabbits during the period of organogenesis at oral doses up to 450 mg/kg/day. This dose is 11 and 22 times, in rats and rabbits, respectively, the maximum recommended human dose (MRHD) of 400 mg/day in adults on a mg/m 2 basis.

Increased fetal resorption and other adverse effects on the fetus in rats at 7.3 to 11 times the MRHD and increase in congenital anomalies in rabbits at 7.3 to 22 times the MRHD on a mg/m 2 basis were observed. No further details on these studies are available.

8.2Lactation Risk Summary Data from published literature report the transfer of trazodone into human milk. There are no data on the effect of trazodone on milk production. Limited data from post marketing reports have not identified and association of adverse effects on the breastfed child.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Trazodone Hydrochloride Tablets and any potential adverse effects on the breastfed child from Trazodone Hydrochloride Tablets or from the underlying maternal condition.

8.4Pediatric Use Safety and effectiveness in the pediatric population have not been established. Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric patients [see Boxed Warning , Warnings and Precautions (5.1) ].

8.5 Geriatric Use Reported…

🤰 Pregnancy ~2 min read ▾

🧒 Pediatric Use 35 words ▾

🧓 Geriatric Use 71 words ▾

8.5Geriatric Use Reported clinical literature and experience with trazodone has not identified differences in responses between elderly and younger patients. However, as experience in the elderly with trazodone hydrochloride is limited, it should be used with caution in geriatric patients. Serotonergic antidepressants have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse reaction [see Warnings and Precautions (5.11) ].

🆘 Overdosage 125 words ▾

10 OVERDOSAGE Death from overdose has occurred in patients ingesting Trazodone Hydrochloride Tablets and other CNS depressant drugs concurrently (alcohol; alcohol and chloral hydrate and diazepam; amobarbital; chlordiazepoxide; or meprobamate). The most severe reactions reported to have occurred with overdose of trazodone alone have been priapism, respiratory arrest, seizures, ECG changes, including QT prolongation and syndrome of inappropriate antidiuretic hormone secretion (SIADH). The reactions reported most frequently have been drowsiness and vomiting.

Overdosage may cause an increase in incidence or severity of any of the reported adverse reactions. There is no specific antidote for trazodone hydrochloride overdose. In managing overdosage, consider the possibility of multiple drug involvement.

For current information on the management of poisoning or overdose, contact a poison control center (1-800-222-1222 or www.poison.org).

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The mechanism of trazodone’s antidepressant action is not fully understood, but is thought to be related to its enhancement of serotonergic activity in the CNS. Trazodone is both a selective serotonin reuptake inhibitor (SSRI) and a 5HT2 receptor antagonist and the net result of this action on serotonergic transmission and its role in trazodone’s antidepressant effect is unknown.

12.2Pharmacodynamics Preclinical studies have shown that trazodone selectively inhibits neuronal reuptake of serotonin (Ki = 367 nM) and acts as an antagonist at 5-HT-2A (Ki = 35.6 nM) serotonin receptors. Trazodone is also an antagonist at several other monoaminergic receptors including 5-HT 2 B (Ki = 78.4 nM), 5-HT 2 C (Ki = 224 nM), α1A (Ki = 153 nM), α2C (Ki = 155 nM) receptors and it is a partial agonist at 5- HT 1 A (Ki = 118 nM) receptor. Trazodone antagonizes alpha 1-adrenergic receptors, a property which may be associated with postural hypotension.

12.3Pharmacokinetics Absorption In humans, trazodone hydrochloride is absorbed after oral administration without selective localization in any tissue. When trazodone hydrochloride is taken shortly after ingestion of food, there may be an increase in the amount of drug absorbed, a decrease in maximum concentration and a lengthening in the time to maximum concentration. Peak plasma levels occur approximately one hour after dosing when trazodone hydrochloride is taken on an empty stomach or 2 hours after dosing when taken with food.

Metabolism In vitro studies in human liver microsomes show that trazodone is metabolized, via oxidative cleavage, to an active metabolite, m- chlorophenylpiperazine (mCPP) by CYP3A4. Other metabolic pathways that may be involved in the metabolism of trazodone have not been well characterized. Trazodone is extensively metabolized; less than 1% of an oral dose is excreted unchanged in the urine.

Elimination In some patients trazodone may accumulate in the plasma. Protein Binding Trazodone is 89 to 95% protein bound in vitro at concentrations attained with therapeutic doses in humans.

🧬 Mechanism of Action 62 words ▾

📦 How Supplied / Storage and Handling 115 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Trazodone Hydrochloride Tablets, USP 100 mg are white to off-white, round, biconvex, uncoated tablets, debossed with ‘J’ and ‘44’ on either side of scoreline (functional) on one side and plain on the other side. NDC: 72162-2531-0: 1000 Tablets in a BOTTLE NDC: 72162-2531-1: 100 Tablets in a BOTTLE NDC: 72162-2531-3: 30 Tablets in a BOTTLE NDC: 72162-2531-5: 500 Tablets in a BOTTLE NDC: 72162-2531-9: 90 Tablets in a BOTTLE Store at 20°C to 25°C (68°F to 77°F). Excursions permitted between 15ºC and 30ºC (59°F to 86ºF) [see USP Controlled Room Temperature].

Dispense with a child-resistant closure in a tight, light-resistant container. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

📋 Description 115 words ▾

11 DESCRIPTION Trazodone hydrochloride tablets for oral administration contain trazodone hydrochloride, a selective serotonin reuptake inhibitor and 5HT 2 receptor antagonist. Trazodone hydrochloride is a triazolopyridine derivative designated as 2-[3-[4-(3-chlorophenyl)-1piperazinyl]propyl]-1,2,4-triazolo [4,3-a]pyridin-3(2H)-one hydrochloride. It is a white odorless crystalline powder which is freely soluble in water.

The structural formula is represented as follows: Molecular Formula: C 19 H 22 CIN 5 O • HCl Molecular Weight: 408.33 Each tablet, for oral administration, contains 50 mg, 100 mg, 150 mg or 300 mg of trazodone hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (physically modified corn (maize) starch), sodium lauryl sulfate, and sodium starch glycolate.

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Medication Guide ). Suicidal Thoughts and Behaviors Advise patients and caregivers to look for the emergence of suicidality, especially early during treatment and when the dosage is adjusted up or down and instruct them to report such symptoms to the healthcare provider [see Box Warning and Warnings and Precautions (5.1) ]. Dosage and Administration Advise patients that Trazodone Hydrochloride Tablets should be taken shortly after a meal or light snack.

Advise patients regarding the importance of following dosage titration instructions [see Dosage and Administration (2) ]. Serotonin Syndrome Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of Trazodone Hydrochloride Tablets with other serotonergic drugs including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John’s Wort, and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid).

Patients should contact their health care provider or report to the emergency room if they experience signs or symptoms of serotonin syndrome [see Warnings and Precautions (5.2) and Drug Interactions (7) ]. Activation of Mania/Hypomania Advise patients and their caregivers to observe for signs of activation of mania/hypomania and instr uct them to report such symptoms to the healthcare provider [see Warnings and Precautions (5.7) ]. Increased Risk of Bleeding Inform patients about the concomitant use of Trazodone Hydrochloride Tablets with aspirin, NSAIDs, other antiplatelet drugs, warfarin, or other anticoagulants because the combined use of drugs that interfere with serotonin reuptake and these medications has been associated with an increased risk of bleeding.

Advise them to inform their health care providers if they are taking or planning to take any prescription or over-the-counter medications that increase the risk of bleeding [see Warnings and Precautions (5.5) ]. Discontinuation Syndrome Advise patients not to abruptly discontinue Trazodone Hydrochloride Tablets and to discuss any tapering regimen with their healthcare provider. Adverse reactions can occur when Trazodone Hydrochloride Tablets are discontinued [see Warnings and Precautions (5.8) ].

Concomitant Medications Advise patients to inform their health care providers if they are taking, or plan to take any prescription or over-the-counter medications since there is a potential for interactions [see Drug Interactions (7.1) ]. Pregnancy Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during therapy with Trazodone Hydrochloride Tablets. Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Trazodone Hydrochloride Tablets during pregnancy [see Use in Special Populations (8.1) ].

Dispense with Medication Guide available at www.aurobindousa.com/medication-guides Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Revised: 04/2025 Dispense with Medication Guide available at www.aurobindousa.com/medication-guides

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Trazodone Hydrochloride Tablets, USP (traz’ oh done hye’’ droeklor’ ide) What is the most important information I should know about Trazodone Hydrochloride Tablets? Antidepressant medicines, depression or other serious mental illnesses, and suicidal thoughts or actions: Talk to your healthcare provider about: All risks and benefits of treatment with antidepressant medicines All treatment choices for depression or other serious mental illnesses 1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.

2. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a higher risk of having suicidal thoughts or actions.

These include people who have or have a family history of bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions. 3. How can I watch for and try to prevent suicidal thoughts and actions?

Pay close attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed. Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts or feelings.

Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you are worried about symptoms. Call a healthcare provider right away if you have any of the following symptoms, especially if they are new, worse, or worry you: Thoughts about suicide or dying Attempts to commit suicide New or worse depression New or worse anxiety Feeling very agitated or restless Panic attacks Trouble sleeping (insomnia) New or worse irritability Acting aggressive, being angry or violent Acting on dangerous impulses An extreme increase in activity and talking (mania) Other unusual changes in behavior or mood What else do I need to know about antidepressant medicines?

Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms. Antidepressants are medicines used to treat depression and other illnesses.

It is important to discuss all the risks of treating depression and also the risks of not treating it. You should discuss all treatment choices with your healthcare provider, not just the use of antidepressants. Antidepressant medicines have other side effects.

Talk to your healthcare provider about the side effects of your medicines. Antidepressant medicines can interact with other medicines. Know all of the medicines that you take.

Keep a list of all medicines to show your healthcare provider. Do not start new medicines without first checking with your healthcare provider. It is not known if Trazodone Hydrochloride Tablets are safe and effective in children.

What is Trazodone Hydrochloride Tablets? Trazodone Hydrochloride Tablets are a prescription medicine used in adults to treat major depressive disorder (MDD). Trazodone Hydrochloride Tablets belongs to a class of medicines known as SSRIs (or selective serotonin reuptake inhibitors).

Do not take Trazodone Hydrochloride Tablets: If you take a monoamine oxidase inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid, and intravenous methylene blue. Do not take an MAOI within 2 weeks of stopping Trazodone Hydrochloride Tablets unless directed to do so by your healthcare provider.

Do not start Trazodone Hydrochloride Tablets if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your healthcare provider. Before you take Trazodone Hydrochloride Tablets tell your healthcare provider about all of your medical conditions, including if you: have heart problems, including QT prolongation or a family history of it ha…

Glossary — plain-language definitions of medical terms used in this label:

anticoagulant: A medicine that slows down blood clotting; often called a blood thinner.

antiplatelet: A medicine that makes platelets, the blood cells that start a clot, less likely to clump together.

case series: A report describing what happened to a small group of patients, with no comparison group.

contraindicated: Should not be used in that situation, because the risk is considered too high.

in vitro: In a laboratory dish or test tube rather than in a living person or animal; results may not carry over to people.

serotonergic: Acting on serotonin, a chemical messenger involved in mood, sleep, and digestion.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

active metabolite: A substance made when the body breaks down a medicine that still has an effect of its own.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

agonist: A substance that switches on a specific target in the body to produce an effect, the way a key turns a lock.

akathisia: A feeling of inner restlessness and an urgent need to keep moving, making it hard to sit still.

anemia: A low level of red blood cells or the oxygen-carrying protein inside them, which can cause tiredness, weakness, and paleness.

antagonist: A substance that blocks a target in the body so a natural signal or another medicine cannot produce its usual effect.

antidote: A treatment that reverses or counteracts the effects of a specific medicine or poison.

anxiety: A feeling of worry, nervousness, or unease, sometimes along with a racing heart or restlessness.

arrhythmia: A heartbeat that is too fast, too slow, or irregular instead of steady.

atrial fibrillation: An irregular, often fast heart rhythm coming from the heart's upper chambers, which can raise the risk of blood clots.

Boxed Warning: The strongest safety warning the FDA can require, set inside a bold black border because the risk it describes can be very serious.

bradycardia: A slower-than-normal heart rate, usually under 60 beats per minute.

cardiac arrest: A sudden stop of the heart's pumping that cuts off blood flow to the body, which is a medical emergency.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

constipation: Having bowel movements less often than usual, or passing stools that are hard, dry, and difficult to move.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

CYP3A4: One of the most important liver and gut enzymes, responsible for breaking down a large share of all medicines.

depression: A lasting low mood with loss of interest that affects everyday life.

diarrhea: Loose, watery bowel movements that happen more often than normal.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

dose reduction: Lowering the amount of a medicine, often to ease side effects or fit a person's needs.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

edema: Swelling caused by extra fluid trapped in the body's tissues.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

flatulence: Passing gas from the bowel; feeling bloated or gassy.

Full Prescribing Information: The complete, detailed label for a prescription medicine that follows the summary highlights.

glaucoma: An eye condition, often linked to high pressure inside the eye, that can slowly damage vision.

heart failure: A condition in which the heart cannot pump blood as well as it should, causing tiredness, breathlessness, and swelling.

hematuria: Blood in the urine.

hemolytic anemia: A shortage of red blood cells caused by them breaking apart faster than the body can replace them.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hypertension: Blood pressure that stays higher than normal, commonly called high blood pressure.

hypomania: A milder form of mania, with raised energy and mood that is less severe and shorter-lasting than a full manic episode.

hyponatremia: A lower-than-normal level of sodium (salt) in the blood.

hypotension: Blood pressure that is lower than normal, which can cause dizziness or fainting.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

inducer: A substance that speeds up an enzyme, which can lower the levels of drugs that enzyme breaks down.

inhibitor: A substance that blocks an enzyme or transporter, which can raise the levels of drugs it normally handles.

INR: A blood test result that shows how quickly blood clots, often used to monitor blood-thinning medicines.

insomnia: Trouble falling asleep, staying asleep, or getting restful sleep.

intravenous: Given directly into a vein through a needle or thin tube; often written as IV.

irritability: Getting annoyed, frustrated, or angry more easily than usual.

lactation: The making and release of milk from a mother's breasts after giving birth.

leukocytosis: A higher-than-normal level of white blood cells, often a sign the body is fighting an infection.

malaise: A general feeling of being unwell, uneasy, or low on energy, without one clear symptom.

mania: A period of unusually high energy, racing thoughts, and an excited or irritable mood that is more extreme than normal.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Medication Guide: An FDA-approved handout written for patients that explains important safety information about certain medicines in plain language.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

metabolite: A new substance formed when the body breaks a medicine down.

myocardial infarction: The medical term for a heart attack, when blood flow to part of the heart muscle is blocked.

narrow therapeutic index: Describes a medicine where the helpful dose and the harmful dose are very close, so small changes in the amount matter a lot.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

organogenesis: The early stage of pregnancy when the developing baby's organs are first forming.

orthostatic hypotension: A drop in blood pressure when you stand up from sitting or lying down, which can cause brief dizziness.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

palpitations: The feeling that your heart is racing, pounding, fluttering, or skipping beats.

paresthesia: A tingling, prickling, or "pins and needles" feeling in the skin, often in the hands or feet.

partial agonist: A substance that switches on a body target only part way, giving a weaker effect than a full activator would.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

placebo: An inactive treatment with no real medicine in it, such as a sugar pill, used for comparison in a study.

placebo-controlled: Describes a study that compares people taking the real medicine against people taking a dummy pill with no active ingredient.

postpartum: The period of time right after a woman gives birth.

potentiate: To make the effect of one medicine stronger by taking another substance along with it.

Pregnancy Exposure Registry: A study that collects health information from women who took a medicine while pregnant to learn how safe it is.

Prescribing Information: The official, detailed document approved by the FDA that tells health professionals how to use a prescription medicine.

protein binding: How much of a medicine sticks to proteins in the blood instead of moving freely through the body.

prothrombin time: A blood test that measures how many seconds it takes for blood to form a clot.

QT prolongation: A longer-than-normal electrical recovery time between heartbeats, seen on a heart tracing (ECG), which can raise the chance of a dangerous heart rhythm.

receptor: A special docking spot on a cell that a medicine or natural body chemical attaches to in order to trigger an effect.

relapse: The return of a cancer after a period of improvement or disappearance.

serotonin syndrome: A potentially dangerous reaction from too much of the brain chemical serotonin, causing agitation, fast heartbeat, sweating, and muscle twitching.

SIADH: Syndrome of inappropriate antidiuretic hormone: the body makes too much of a water-holding hormone, which lowers the level of sodium (salt) in the blood.

suicidality: A general term covering both thoughts about ending one's own life and actions taken toward it.

syncope: The medical term for fainting, a brief loss of consciousness from a temporary drop in blood flow to the brain.

tachycardia: A faster-than-normal heart rate, usually over 100 beats per minute.

teratogenic: Able to cause physical birth defects in a developing baby when a medicine is taken during pregnancy.

therapeutic index: A measure of how much room there is between a helpful dose of a medicine and a dose that could be harmful.

titration: Slowly adjusting a medicine's dose up or down in small steps to find the amount that works best with the fewest side effects.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

← 72162-2529-01 · Bryant 72162-2532-00 · Bryant →

For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.

TRAZODONE HYDROCHLORIDE 100 mg Tablet, 90-count

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8 USE IN SPECIFIC POPULATIONS

8.5 Geriatric Use Reported…

12 CLINICAL PHARMACOLOGY

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