TRAZODONE HYDROCHLORIDE 50 mg/1
TRAZODONE HYDROCHLORIDE · TABLET · Advanced Rx of Tennessee, LLC
TRAZODONE HYDROCHLORIDE is a tablet containing trazodone hydrochloride at 50 mg/1, taken oral. Manufactured by Advanced Rx of Tennessee, LLC.
Key Facts
- Brand Name
- TRAZODONE HYDROCHLORIDE
- Generic Name
- TRAZODONE HYDROCHLORIDE
- NDC Code (Product)
80425-0502- Manufacturer
- Advanced Rx of Tennessee, LLC
- Strength
- 50 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA204852
- Marketing Start
- 03/20/2025
Recall History
AVKARE Inc.
Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.
Zydus Pharmaceuticals (USA) Inc
Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.
Granules Pharmaceuticals Inc.
Presence of Foreign Tablets/Capsules
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Trazodone is a selective serotonin reuptake inhibitor indicated for the treatment of major depressive disorder (MDD) ( 1 ). Trazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults.
Dosage & Administration
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 ). 2.1 Dose 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 re…
Contraindications
4 CONTRAINDICATIONS None ( 4 ). Concomitant use of monoamine oxidase inhibitors (MAOIs), or use within 14 days of stopping MAOIs ( 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 )].
Drug Interactions
7 DRUG INTERACTIONS CNS Depressants: Trazodone may enhance effects of alcohol, barbiturates, or other CNS depressants ( 7 ). CYP3A4 Inhibitors: Consider trazodone dose reduction based on tolerability ( 2.5 , 7 ). CYP3A4 Inducers: Increase in trazodone 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 ). MAOIs MAOIs should not be used within 14 days of trazodone [see Warnings and Precautions ( 5.8 )]. Central Nervous System (CNS) Depressants Trazodone may enhance the response to alcohol, barbiturates, and other CNS depressants. Cytochrome P450 3A4 Inhibitors In vitro drug metabolism studies suggest that there is a potential for drug interactions when trazodone is given with cytochrome P450 3A4 (CYP3A4) inhibitors. The effect of short-term administration of ritonavir (200 mg twice daily, 4 doses) on the pharmacokinetics of a single dose of trazodone (50 mg) has been studied in 10 healthy subjects. The C max of trazodone increased by 34%, the AUC increased 2.4 fold, the half-life increased by 2.2 fold, and the clearance decreased by 52%. Adverse eff…
Adverse Reactions
6 ADVERSE REACTIONS 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 Zydus Pharmaceuticals (USA) Inc. at 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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 )] 6…
Frequently Asked Questions
What is TRAZODONE HYDROCHLORIDE used for?
TRAZODONE HYDROCHLORIDE contains TRAZODONE HYDROCHLORIDE. It is a tablet taken oral. Consult your doctor for specific uses.
Is TRAZODONE HYDROCHLORIDE a controlled substance?
TRAZODONE HYDROCHLORIDE is not classified as a controlled substance by the DEA.
What is the generic name for TRAZODONE HYDROCHLORIDE?
The generic name for TRAZODONE HYDROCHLORIDE is TRAZODONE HYDROCHLORIDE. There are 12 other brand versions of TRAZODONE HYDROCHLORIDE.
What is the NDC code for TRAZODONE HYDROCHLORIDE 50 mg/1?
The NDC (National Drug Code) for TRAZODONE HYDROCHLORIDE 50 mg/1 is 80425-0502, listed by Advanced Rx of Tennessee, LLC.
Other Trazodone Brands
See all →- RALDESY TM10 mg/mL30698-455
- Trazodone Hydrochloride50 mg/142291-868
- Trazodone Hydrochloride150 mg/150090-7439
- Trazodone Hydrochloride50 mg/150090-7943
- Trazodone Hydrochloride150 mg/150268-776
- Trazodone Hydrochloride50 mg/151655-366
- Trazodone Hydrochloride150 mg/168382-807
- Trazodone Hydrochloride150 mg/170518-2180
- Trazodone Hydrochloride100 mg/170518-3426
- Trazodone Hydrochloride150 mg/171205-815
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)