Trazodone Hydrochloride Tablets are indicated for the treatment of major depressive disorder (MDD) in adults.
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) ].
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) ].
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) ].
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.
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).
Trazodone Hydrochloride Tablets, USP 300 mg are 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. NDC: 71335-3025-1: 500 Tablets in a BOTTLE Directions for using the correct score when breaking the tablet, please refer to the following: -For 100 mg, break the score on either the left or right side of the tablet (one-third of a tablet) -For 150 mg, break the score down the middle of the tablet (one-half of a tablet). -For 200 mg, break the score on either the left or right side of the tablet (two-thirds of a tablet). -For 300 mg, use the entire tablet. 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
Trazodone Hydrochloride 300mg Tablets
| Class | Version | Type | Effective |
|---|---|---|---|
| TRAZODONE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ac7a3d9b-58c0-4ffc-a3eb-ed863453525e | Product name | 1 | 20250730 |
| b2f15d64-48ea-ba98-af5c-91f410667b31 | Product name | 5 | 20250314 |
| d8e7f61b-4ab5-0dbe-2706-4e11b6079b87 | Product name | 1 | 20140508 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71335-3025-1 | TRAZODONE HYDROCHLORIDE | 500 in 1 BOTTLE | TABLET | 500 | 100 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 71335-3025-1 | EA - Each | 71335-3025 | d7cf0ba3-4b93-46f0-abce-649d06bf3f06 | 1 | 2026-01-08 |
| 13107-082-01 | EA - Each | 13107-082 | 210a4664-b9dc-4030-b2a9-c8eabef81e77 | 1 | 2021-12-08 |
| Product NDC | Package NDC |
|---|---|
| 71335-3025 | 71335-3025-1 |
| 13107-082 |
| Name | UNII | Kind |
|---|---|---|
| TRAZODONE HYDROCHLORIDE | 6E8ZO8LRNM | ACTIB |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| SODIUM LAURYL SULFATE | 368GB5141J | IACT |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | 5856J3G2A2 | IACT |
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) ].
Trazodone Hydrochloride Tablets are indicated for the treatment of major depressive disorder (MDD) in adults.
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.
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) ].
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) ]
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).
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.
The efficacy and safety of trazodone hydrochloride were established from inpatient and outpatient trials of the trazodone immediate release formulation in the treatment of major depressive disorder.
Trazodone Hydrochloride Tablets, USP 300 mg are 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. NDC: 71335-3025-1: 500 Tablets in a BOTTLE Directions for using the correct score when breaking the tablet, please refer to the following: -For 100 mg, break the score on either the left or right side of the tablet (one-third of a tablet) -For 150 mg, break the score down the middle of the tablet (one-half of a tablet). -For 200 mg, break the score on either the left or right side of the tablet (two-thirds of a tablet). -For 300 mg, use the entire tablet. 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
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 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 have ever had a heart attack have bipolar disorder have liver or kidney problems have other serious medical conditions are pregnant or plan to become pregnant. It is not known if Trazodone Hydrochloride Tablets will harm your unborn baby. Talk to your healthcare provider about the risk to your unborn baby if you take Trazodone Hydrochloride Tablets. If you become pregnant during treatment with Trazodone Hydrochloride Tablets, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants. You can register by calling 1-844-405-6185. are breastfeeding or plan to breastfeed. Trazodone Hydrochloride Tablets passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take Trazodone Hydrochloride Tablets. have taken a Monoamine Oxidase Inhibitor (MAOI) or if you have stopped taking an MAOI in the last 2 weeks. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using Trazodone Hydrochloride Tablets with certain other medicines can affect each other causing serious side effects. Especially tell your healthcare provider if you take: triptans used to treat migraine headache medicines used to treat mood, anxiety, psychotic or thought disorders, including tricyclics, lithium, SSRIs, SNRIs, buspirone, or antipsychotics tramadol over-the-counter supplements such as tryptophan or St. John’s Wort nonsteroidal anti-inflammatory drugs (NSAIDS) aspirin warfarin (Coumadin, Jantoven) phenytoin (Mesantoin) diuretics Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine. How should I take Trazodone Hydrochloride Tablets? Take Trazodone Hydrochloride Tablets exactly as your healthcare provider tells you. Trazodone Hydrochloride Tablets should be taken shortly after a meal or light snack. If you feel drowsy after taking Trazodone Hydrochloride Tablets, talk to your healthcare provider. Your healthcare provider may change your dose or the time of day you take your Trazodone Hydrochloride Tablets. Do not stop taking Trazodone Hydrochloride Tablets without talking to your healthcare provider. Trazodone Hydrochloride Tablets should be swallowed whole or broken in half along the score line. Do not chew or crush Trazodone Hydrochloride Tablets. Tell your healthcare provider if you cannot swallow trazodone either whole or as a half tablet. If you take too much Trazodone Hydrochloride Tablets, call your healthcare provider, your Poison Control Center at 1-800-222-1222, or go to the nearest emergency room right away. What should I avoid while taking Trazodone Hydrochloride Tablets? Do not drive, operate heavy machinery, or do other dangerous activities until you know how Trazodone Hydrochloride Tablets affects you. Trazodone Hydrochloride Tablets can slow your thinking and motor skills. Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking Trazodone Hydrochloride Tablets until you talk with your healthcare provider. Trazodone Hydrochloride Tablets may make your sleepiness or dizziness worse if you take it with alcohol or other medicines that cause sleepiness or dizziness. What are the possible side effects of Trazodone Hydrochloride Tablets? Trazodone Hydrochloride Tablets can cause serious side effects or death, including: See “What is the most important information I should know about Trazodone Hydrochloride Tablets?” Serotonin syndrome. Symptoms of serotonin syndrome include: agitation, hallucinations, and problems with coordination, fast heartbeat, tight muscles, trouble walking, sweating, fever, nausea, vomiting, and diarrhea. Irregular or fast heartbeat or faint (QT prolongation) Low blood pressure. You feel dizzy or faint when you change positions (go from sitting to standing) Unusual bruising or bleeding Erection lasting for more than 6 hours (priapis...
Trazodone Hydrochloride 300mg Tablets