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Trazodone Hydrochloride 100 mg Tablet, Film Coated, 90-count — NDC 69584-0885-09 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Trazodone Hydrochloride 100 mg Tablet, Film Coated, 90-count — NDC 69584-885-09 (Billing 69584-0885-09)

by Oxford Pharmaceuticals, LLC · 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

This is a package of 90 tablets of Trazodone Hydrochloride 100 mg Tablet, Film Coated from Oxford Pharmaceuticals, LLC, marketed since Mar 2023 and currently FDA-listed. It is the main listing for this product, which comes in 4 package sizes.

NDC 69584-0885-09
🏷️ FDA NDC (as labeled) 69584-885-09 billing pads the product segment with a zero
This package
Contains90-count Pack sizes4 compare ↓
Main listing for product 69584-885 · Also comes in: 100 tablets 69584-885-10 500 tablets 69584-885-50 1000 tablets 69584-885-90
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

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

⚠️
Other active recalls for Trazodone Hydrochloride (different manufacturers) — 3 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Aug 24, 2026 — Presence of Foreign Tablets/Capsules (Teva Pharmaceuticals USA, Inc) · FDA recall D-0834-2026
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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 69584-885-09
Product NDC 69584-885
11-digit billing NDC 69584088509
RxCUI 856373, 856377
UNII 6E8ZO8LRNM
UPC 0369584885909, 0369584884902
Application # ANDA072193
SPL Set ID 283c8236-9776-44cb-b7b2-1024689de736
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 2023-03-01
Route ORAL
Dosage form TABLET, FILM COATED
Substance TRAZODONE HYDROCHLORIDE
TE code (Orange Book) AB · RLD · RS
Quick answers
  • RxCUI (RxNorm): 856373
Why two NDCs? The FDA registers this code as 69584-885-09 — a 5-3-2 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 product segment → 69584-0885-09. 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.

Clinical

📖 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
  • It treats major depressive disorder in adults. It comes as tablets and as Raldesy oral solution. Your prescriber will decide if it's right for you.
  • Take it by mouth shortly after a meal or light snack, in divided doses as directed. If it makes you drowsy, your prescriber may have you take most of the dose at bedtime. Follow th...
  • Please don't stop suddenly. The dose should be lowered gradually, and your prescriber will guide you.
  • Drowsiness, dizziness, dry mouth, blurred vision, fatigue, headache and nausea are common. Stand up slowly, and use caution driving until you know how it affects you. Call your doc...
📖 Read our full Trazodone guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
1
Nutrient depletion considerations

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

🧪 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.

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 systemPer eachPer 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 · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 100 tablets 500 tablets 1000 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
69584-0885-10 69584-885-10 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 2023-03-01 — Active
69584-0885-50 69584-885-50 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 2023-03-01 — Active
69584-0885-90 69584-885-90 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 2023-03-01 — Active
69584-0885-09 You're viewing this Main listing 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 2026-07-10 — Active

You're viewing the smallest of 4 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 90-count package — 90 tablet, film coated in 1 bottle, plastic.
How does this package differ from NDC 69584-0885-10?
Both are Trazodone Hydrochloride 100 mg Tablet, Film Coated — the drug itself is identical. This page's package is the 90-count one, while NDC 69584-0885-10 is the 100 tablets package.
What NDC number is used to bill for this package of Trazodone Hydrochloride 100 mg Tablet, Film Coated?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice 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 mgthis 69584-0885-09 Oxford 90 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 mg 72162-2531-00 Bryant 1000 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 —
Trazodone Hydrochloride 100 mg 50090-8080-00 A-S 30 tablets — AB FDA listed —
Trazodone Hydrochloride 100 mg 50090-8077-00 A-S 1000 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

🏛️
2023
On the market since
Mar 2023
📍
2026
Currently FDA-listed
3 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.

What it looks like

Color White
ShapeRound
Imprint8;85;O
Size11 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 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • 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 VH2XOU12IE
    Polydextrose is a synthetic polymer made from dextrose (sugar) that acts as a bulking agent and filler in medicines. It helps give tablets and capsules proper volume and texture while often adding slight sweetness.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII U725QWY32X
    Povidone K30 is a synthetic polymer made from petroleum. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the stomach so the medicine can be absorbed.
  • 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 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.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

9 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.

Manufacturer & labeler

LabelerOxford Pharmaceuticals, LLC
Application holderOXFORD PHARMACEUTICALS LLC
FDA applicationANDA072193 (ANDA)
Labeler code69584
First marketedMar 2023
Product typeHuman Prescription Drug
Portfolio35 products on file
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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). 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 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🔒 Drug Abuse and Dependence 🔒 Controlled Substance 🧪 Nonclinical Toxicology 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 126 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 ( 2.1 ).

Trazodone hydrochloride tablets should be taken shortly after a meal or light snack ( 2.2 ). Tablets should be swallowed whole or broken in half along the score line, and should not be chewed or crushed ( 2.2 ). When discontinued, gradual dose reduction is recommended ( 2.6 ).

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 70 words ▾

3 DOSAGE FORMS AND STRENGTHS Trazodone hydrochloride tablets are available in the following strengths: 50 mg - white, film-coated, round, convex, scored tablets, debossed "8 | 84" on one side and debossed “O” on the other side. 100 mg - white, film-coated, round, convex, scored tablets, debossed "8 | 85" on one side and debossed “O” on the other side. Scored tablets: 50 mg and 100 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 Trials of Antidepressants in Pediatric and Adult Patients 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… [Excerpted — this section continues on DailyMed.]

🤒 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 Oxford Pharmaceuticals, LLC at 1-844-508-1455 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 Dizziness/Light-Headedness 20% 5% 28% 15% Drowsiness 24% 6% 41% 20% 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.

6.2Postmarketing 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: cardiospasm, 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… [Excerpted — this section continues on DailyMed.]

🔄 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 reduc… [Excerpted — this section continues on DailyMed.]

👥 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/pregnancyregistry/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 embryofetal 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 than 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 postmarketing reports have not identified an 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 and any potential adverse effects on the breastfed child from trazodone hydrochloride 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) ].

8.5Geriatric Use Reported clinical literature a… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

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/pregnancyregistry/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 embryofetal 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 than 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.

🧒 Pediatric Use 35 words ▾

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) ].

🧓 Geriatric Use 72 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 128 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 hydrochloride tablets 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 ~1 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-HT2B (Ki = 78.4 nM), 5-HT2C (Ki = 224 nM), α1A (Ki = 153 nM), α2C (Ki = 155 nM) receptors and it is a partial agonist at 5-HT1A (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 ▾

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.

📦 How Supplied / Storage and Handling 140 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Trazodone hydrochloride tablets USP, 50 mg are white, film-coated, round, convex, scored tablets, debossed "8 | 84" on one side and debossed “O” on the other side. They are available as follows: Bottles of 90: NDC 69584-884-09 Bottles of 100: NDC 69584-884-10 Bottles of 500: NDC 69584-884-50 Bottles of 1000: NDC 69584-884-90 Trazodone hydrochloride tablets USP, 100 mg are white, film-coated, round, convex, scored tablets, debossed "8 | 85" on one side and debossed “O” on the other side.

They are available as follows: Bottles of 90: NDC 69584-885-09 Bottles of 100: NDC 69584-885-10 Bottles of 500: NDC 69584-885-50 Bottles of 1000: NDC 69584-885-90 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP. Dispense with Medication Guide available at: https://www.oxford-rx.com/med-guides

📋 Description 91 words ▾

11 DESCRIPTION Trazodone hydrochloride tablets for oral administration contain trazodone hydrochloride, a selective serotonin reuptake inhibitor and 5HT2 receptor antagonist. Trazodone hydrochloride tablets are a triazolopyridine derivative designated as 2-[3-[4-(3-chlorophenyl)-1-­piperazinyl]propyl]-1,2,4-triazolo [4,3-a]pyridin-3(2 H )-one hydrochloride. It is a white odorless crystalline powder which is freely soluble in water.

The structural formula is represented as follows: Each tablet, for oral administration, contains 50 mg or 100 mg of trazodone hydrochloride, USP. In addition, each tablet contains hypromellose, lactose monohydrate, magnesium stearate, polydextrose, polyethylene glycol, povidone, pregelatinized corn starch, silicon dioxide, and titanium dioxide.

💬 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 instruct 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 during pregnancy [ see Use in Special Populations (8.1) ].

🧬 Pharmacokinetics 167 words ▾

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.

🧬 Pharmacodynamics 90 words ▾

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-HT2B (Ki = 78.4 nM), 5-HT2C (Ki = 224 nM), α1A (Ki = 153 nM), α2C (Ki = 155 nM) receptors and it is a partial agonist at 5-HT1A (Ki = 118 nM) receptor. Trazodone antagonizes alpha 1-adrenergic receptors, a property which may be associated with postural hypotension.

🔬 Clinical Studies 30 words ▾

14 CLINICAL STUDIES 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.

🔒 Drug Abuse and Dependence 50 words ▾

9 DRUG ABUSE AND DEPENDENCE

9.1Controlled Substance Trazodone hydrochloride tablets are not a controlled substance.

9.2Abuse Although trazodone hydrochloride has not been systematically studied in preclinical or clinical studies for its potential for abuse, no indication of drug-seeking behavior was seen in the clinical studies with trazodone hydrochloride.

🔒 Controlled Substance 11 words ▾

9.1Controlled Substance Trazodone hydrochloride tablets are not a controlled substance.

🧪 Nonclinical Toxicology 80 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis No drug- or dose-related occurrence of carcinogenesis was evident in rats receiving trazodone in daily oral doses up to 7.3 times the maximum recommended human dose (MRHD) of 400 mg/day in adults on mg/m 2 basis. Mutagenesis No genotoxicity studies were conducted with trazodone. Impairment of Fertility Trazodone has no effect on fertility in rats at doses up to 7.3 times the MRHD in adults on a mg/m 2 basis.

📄 Package Label / Principal Display Panel 205 words ▾

PRINCIPAL DISPLAY PANEL NDC 69584-884-90 traZODone Hydrochloride Tablets, USP 50 mg PHARMACIST: PLEASE DISPENSE MEDICATION GUIDE TO EACH PATIENT Rx ONLY 1000 TABLETS Print Medication Guide at: https://www.oxford-rx.com/med-guides EACH TABLET CONTAINS: Trazodone Hydrochloride, USP...........50 mg USUAL DOSAGE: See package insert for full prescribing information. KEEP THIS AND ALL MEDICATIONS OUT OF REACH OF CHILDREN DISPENSE contents with a child-resistant closure (as required) and in a tight, light-resistant container as defined in the USP/NF.

STORE at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. KEEP TIGHTLY CLOSED MANUFACTURED BY: OXFORD PHARMACEUTICALS, LLC BIRMINGHAM, ALABAMA 35211 8000119 Rev. 02/2026 R01 OXFORD PHARMACEUTICALS, LLC NDC 69584-885-90 traZODone Hydrochloride Tablets, USP 100 mg PHARMACIST: PLEASE DISPENSE MEDICATION GUIDE TO EACH PATIENT Rx ONLY 1000 TABLETS Print Medication Guide at: https://www.oxford-rx.com/med-guides EACH TABLET CONTAINS: Trazodone Hydrochloride, USP...........100 mg USUAL DOSAGE: See package insert for full prescribing information.

KEEP THIS AND ALL MEDICATIONS OUT OF REACH OF CHILDREN DISPENSE contents with a child-resistant closure (as required) and in a tight, light-resistant container as defined in the USP/NF. STORE at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. KEEP TIGHTLY CLOSED MANUFACTURED BY: OXFORD PHARMACEUTICALS, LLC BIRMINGHAM, ALABAMA 35211 8000122 Rev.

02/2026 R02 OXFORD PHARMACEUTICALS, LLC

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

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Yes — the FDA directory lists 3 other package presentations of this same product, including 100 tablets (69584-0885-10), 500 tablets (69584-0885-50), 1000 tablets (69584-0885-90). Each has its own NDC and its own page — see the package list near the top of this page.
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← 69584-0884-10 · Oxford 69587-0001-01 · MIPS →
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