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TRAZODONE HYDROCHLORIDE 100 mg Tablet, 100-count — NDC 64980-0673-01 package photo

TRAZODONE HYDROCHLORIDE 100 mg Tablet, 100-count

by Rising Pharma Holdings, Inc. · 100 TABLET in 1 BOTTLE (64980-673-01)
NDC 64980-0673-01
🏷️ FDA NDC (as labeled) 64980-673-01 billing pads the product segment with a zero
This package
Contains100-count Cost per ea$0.0506 NADAC Per package$5.06 / 100 tablets Pack sizes3 compare ↓
Also priced by: Medicaid pays $0.2143/unit · Part D plans $0.2383/unit — full pricing hub ↓
Also comes in: 500 tablets 64980-0673-50 1000 tablets 64980-0673-10
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

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

FDA NDC (as labeled) 64980-673-01
Product NDC 64980-673
11-digit billing NDC 64980067301
NCPDP billing unit EA — each (per item)
RxCUI 856364, 856369, 856373, 856377
UNII 6E8ZO8LRNM
UPC 0364980675017
Application # ANDA217740
SPL Set ID ef26e4f0-f31f-4efa-9938-28c886cf3d1d
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 2025-01-29
Route ORAL
Dosage form TABLET
Substance TRAZODONE HYDROCHLORIDE
GPI-14 58120080100310
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 64980-673-01 — 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 → 64980-0673-01. 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

LabelerRising Pharma Holdings, Inc.
Application holderGRAVITI PHARMACEUTICALS PRIVATE LTD
FDA applicationANDA217740 (ANDA)
Labeler code64980
First marketedJan 2025
Product typeHuman Prescription Drug
Portfolio525 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.

🩺 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 — that's clinical depression — in adults. It's available as tablets (Trazodone HCl, Trazodone Hydrochloride) and as an...
  • Yes, and this actually matters. You should take it shortly after a meal or light snack — not on an empty stomach. Food changes how your body absorbs it, so taking it consistently w...
  • Drowsiness is one of the most common side effects, and it's not unusual to feel it, especially when you first start or when your dose goes up. Your prescriber may suggest taking mo...
  • It's best to avoid alcohol while on trazodone. Trazodone can make the effects of alcohol — and other sedating substances — much stronger than normal. That combination can cause exc...
📖 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.

💊 What it looks like

Color White
ShapeOval
Imprint31;1
Size21 mm
ScoringScore: 3
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 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 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 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 H8AV0SQX4D
    A modified starch derived from potato or corn starch. It absorbs water quickly and helps tablets or capsules break apart and dissolve in the stomach, acting as a disintegrant to ensure the medicine releases its active ingredients properly.
  • 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 systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.051 $5.06 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $0.2143 $21.43 / 100 tablets
Medicare drug plans payPart D · Q2 2026 $0.2383 $23.83 / 100 tablets
NADAC price history (per ea) — tap or hover for the price & month
Dec 2025 Feb 2026 May 2026 Aug 2026 $0.055 $0.050
▼ Down 7% over the last 9 months.
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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Trazodone Hydrochloride 100 mg 16729-0300-01 Accord 100 tablets $0.050 AB Availability likely +0%
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 mgthis 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 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 —
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

🏛️
2025
On the market since
Jan 2025
📍
2026
Currently FDA-listed
1 year 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 64980-0673-01, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q3 2025 – Q4 2025 · 2 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
9.9K
Units reimbursed last 4 qtrs
533.5K
Gross reimbursed last 4 qtrs
$114.3K
Avg / prescription
$11.53
Avg / unit
$0.2143
Latest quarter Q4 2025
9.9KRx
Medicaid pays / ea
$0.2143
gross reimbursed
vs
NADAC / ea
$0.0506
acquisition cost
=
Spread
+$0.1637
+324% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
54% FFS 46% MCO
Fee-for-service · 5,370 Rx Managed care · 4,551 Rx
State Medicaid map
Alaska: no data reported AK Maine: 30,161 units · 2,162 per 100k residents ME Washington: 2,875 units · 36.8 per 100k residents WA Idaho: 9,394 units · 478 per 100k residents ID Montana: 934 units · 82.5 per 100k residents MT North Dakota: no data reported ND Minnesota: 9,208 units · 161 per 100k residents MN Wisconsin: 62,392 units · 1,056 per 100k residents WI Michigan: 9,748 units · 97.1 per 100k residents MI New York: 37,747 units · 193 per 100k residents NY Vermont: 2,775 units · 429 per 100k residents VT New Hampshire: 1,004 units · 71.6 per 100k residents NH Oregon: 3,677 units · 86.9 per 100k residents OR Nevada: 4,477 units · 140 per 100k residents NV Wyoming: 407 units · 69.7 per 100k residents WY South Dakota: no data reported SD Iowa: 7,750 units · 242 per 100k residents IA Illinois: 63,251 units · 504 per 100k residents IL Indiana: 4,524 units · 65.9 per 100k residents IN Ohio: 16,022 units · 136 per 100k residents OH Pennsylvania: 5,681 units · 43.8 per 100k residents PA New Jersey: 11,900 units · 128 per 100k residents NJ Massachusetts: 4,456 units · 63.6 per 100k residents MA California: 71,716 units · 184 per 100k residents CA Utah: 2,203 units · 64.5 per 100k residents UT Colorado: 5,740 units · 97.7 per 100k residents CO Nebraska: 3,626 units · 183 per 100k residents NE Missouri: 6,285 units · 101 per 100k residents MO Kentucky: 15,556 units · 344 per 100k residents KY West Virginia: 6,247 units · 353 per 100k residents WV Virginia: 3,340 units · 38.3 per 100k residents VA Maryland: 12,303 units · 199 per 100k residents MD Connecticut: 3,506 units · 96.9 per 100k residents CT Rhode Island: 1,260 units · 115 per 100k residents RI Arizona: 7,320 units · 98.5 per 100k residents AZ New Mexico: 4,095 units · 194 per 100k residents NM Kansas: 795 units · 27.0 per 100k residents KS Arkansas: 4,421 units · 144 per 100k residents AR Tennessee: 11,484 units · 161 per 100k residents TN North Carolina: 11,470 units · 106 per 100k residents NC South Carolina: 3,405 units · 63.4 per 100k residents SC Delaware: 3,670 units · 356 per 100k residents DE Oklahoma: 15,620 units · 385 per 100k residents OK Louisiana: 9,330 units · 204 per 100k residents LA Mississippi: 6,104 units · 208 per 100k residents MS Alabama: 2,655 units · 52.0 per 100k residents AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: 1,295 units · 90.2 per 100k residents HI Texas: 1,530 units · 5.0 per 100k residents TX Florida: 30,175 units · 133 per 100k residents FL
Units reimbursed · per 100k residents
5.02,162
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Maine 2,162 /100k
2 Wisconsin 1,056 /100k
3 Illinois 504 /100k
4 Idaho 478 /100k
5 Vermont 429 /100k
6 Oklahoma 385 /100k
7 Delaware 356 /100k
8 West Virginia 353 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
100 tablets this page64980-0673-01 9,921 Rx · $114,346
500 tablets64980-0673-50 383 Rx · $4,484
1000 tablets64980-0673-10 No Medicaid data
Drug total (last 4 qtrs): 10,304 Rx · 551,550 units · $118,830 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

🔬 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

15,550 reports
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
2021 2022 2024 2026 1,447 423
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 NDCDescription Per unit Per pack Marketing startStatus
64980-0673-01 You're viewing this 100 TABLET in 1 BOTTLE (64980-673-01) $0.0506 / ea $5.06 2025-01-29 Active
64980-0673-10 1000 TABLET in 1 BOTTLE (64980-673-10) $0.0506 / ea $50.57 2025-04-11 Active
64980-0673-50 500 TABLET in 1 BOTTLE (64980-673-50) $0.0506 / ea $25.29 2025-01-29 Active

You're viewing the smallest of 3 pack sizes for this product.

This pack has the lowest per-ea cost of the 3 priced pack sizes ($0.0506 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 96% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 64980-0673-01?
NDC 64980-0673-01 is a 100-count package — 100 tablet in 1 bottle.
What is the difference between NDC 64980-0673-01 and NDC 64980-0673-50?
Both are TRAZODONE HYDROCHLORIDE 100 mg Tablet — the drug itself is identical. NDC 64980-0673-01 is the 100-count package, while NDC 64980-0673-50 is the 500 tablets package.
What NDC number is used to bill for this package of TRAZODONE HYDROCHLORIDE 100 mg Tablet?
Bill NDC 64980-0673-01 — the 11-digit billing format is 64980067301. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 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 125 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 38 words ▾

1 INDICATIONS AND USAGE Trazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults. Trazodone hydrochloride tablets are 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 dose based on tolerability when trazodone is coadministered with a strong CYP3A4 inhibitor [see Drug Interactions ( 7.1 )]. Coadministration with Strong CYP3A4 Inducers Consider increasing trazodone dose based on therapeutic response when trazodone is 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 192 words ▾

3 DOSAGE FORMS AND STRENGTHS Trazodone Hydrochloride Tablets, USP are available in the following strengths: 50 mg: White to off-white, round shape, functionally scored, biconvex tablets, debossed with "44" over score line on one side and plain on other side. 100 mg: White to off-white, round shape, functionally scored, biconvex tablets, debossed with "229" over score line on one side and plain on other side. 150 mg: White to off-white, oval shape, functionally scored, flat faced beveled tablets having one full bisect and two trisect notches on one side and two trisects on the other side.

The full bisected side of the tablet is debossed with '23' on one side of bisect and '0' on other bisect segments on upper side. 300 mg: White to off-white, oval shape, functionally scored, flat faced beveled tablets having one full bisect and two trisect notches on one side and two trisects on the other side. The full bisected side of the tablet is debossed with '31' on one side of bisect and '1' on other bisect segments on upper side.

Scored tablets of 50 mg, 100 mg, 150 mg and 300 mg ( 3 ).

⛔ Contraindications 67 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 1,000 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 1,000 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, 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…

🤒 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, Rising Pharma Holdings, Inc. at 1-844-874-7464 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 Controled 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. 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 at doses of 100 mg…

🔄 Drug Interactions ~2 min read ▾

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 ).

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 increases the risk of serotonin syndrome. Intervention: Trazodone is 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 and other serotonergic drugs increases the risk of serotonin syndrome. Intervention: Monitor patients for signs and symptoms of serotonin syndrome, particularly during trazodone initiation. If serotonin syndrome occurs, consider discontinuation of trazodone 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 may potentiate the risk of bleeding.

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

Intervention: If trazodone is used with a potent CYP3A4 inhibitor, the risk of adverse reactions, including cardiac arrhythmias, may be increased and a lower dose of trazodone 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 and strong CYP3A4 inducers decreased the exposure of trazodone compared to the use of trazodone alone. Intervention: Patients should be closely monitored to see if there is a need for an increased dose of trazodone 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 can increase digoxin or phenytoin concentrations.

Intervention: Measure serum digoxin or phenytoin concentrations before initiating concomitant use of trazodone. Continue monitoring and reduce digoxin or phenytoin dose as necessary. Examples: digoxin, phenytoin Central Nervous System (CNS) Depressants Clinical Impact: Trazodone may enhance the response CNS depressants.

Intervention: Patients should be counseled that trazodone may enhance the response to alcohol, barbiturates, and other CNS depressants. Examples: alcohol, barbiturates QT Interval Prolongation Clinical Impact: Concomitant use of drugs that prolong the QT…

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Published prospective cohort studies, case series, and case reports over several decades with trazodone 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 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 postmarketing 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 and any potential adverse effects on the breastfed child from trazodone 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 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 ) ].…

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Published prospective cohort studies, case series, and case reports over several decades with trazodone 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 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.

🧒 Pediatric Use 36 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 74 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 124 words ▾

10 OVERDOSAGE Death from overdose has occurred in patients ingesting trazodone 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 ~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 5HT 2 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 63 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 5HT 2 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 ~2 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Trazodone hydrochloride tablets, USP 50 mg are available for oral administration as, White to off-white, round shape, functionally scored, biconvex tablets, debossed with "44" over score line on one side and plain on other side. Bottles of 100 (NDC 64980-672-01) Bottles of 500 (NDC 64980-672-50) Bottles of 1,000 (NDC 64980-672-10) Trazodone hydrochloride tablets, USP 100 mg are available for oral administration as White to off-white, round shape, functionally scored, biconvex tablets, debossed with "229" over score line on one side and plain on other side.

Bottles of 100 (NDC 64980-673-01) Bottles of 500 (NDC 64980-673-50) Bottles of 1,000 (NDC 64980-673-10) Trazodone hydrochloride tablets, USP 150 mg are available for oral administration as White to off-white, oval shape, functionally scored, flat faced beveled tablets having one full bisect and two trisect notches on one side and two trisects on the other side. The full bisected side of the tablet is debossed with '23' on one side of bisect and '0' on other bisect segments on upper side. Bottles of 100 (NDC 64980-674-01) Bottles of 500 (NDC 64980-674-50) Directions for using the correct score when breaking the tablet, please refer to the following: -For 50 mg, break the score on either the left or right side of the tablet (one-third of a tablet). -For 75 mg, break the score down the middle of the tablet (one-half of a tablet). -For 100 mg, break the score on either the left or right side of the tablet (two-thirds of a tablet). -For 150 mg, use the entire tablet.

Trazodone hydrochloride tablets, USP 300 mg are available for oral administration as White to off-white, oval shape, functionally scored, flat faced beveled tablets having one full bisect and two trisect notches on one side and two trisects on the other side. The full bisected side of the tablet is debossed with '31' on one side of bisect and '1' on other bisect segments on upper side. Bottles of 100 (NDC 64980-675-01) 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 from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense with a child-resistant closure in a tight, light-resistant container. 50mg-score 75mg-score 100mg-score 150mg-tablet 100mg-break 150mg-break 200mg-break 300mg-break

📋 Description 107 words ▾

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

The structural formula is represented as follows Each tablet, for oral administration, contains 50 mg, 100 mg, 150 mg or 300 mg of trazodone hydrochloride. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate, sodium starch glycolate. FDA approved dissolution specifications differ from USP. structure

💬 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 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 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 is 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. [see Use in Special Populations ( 8.1 )]. Dispense with Medication Guide available at https://risingpharma.com/Medguides/Trazodone.pdf Manufactured by: Graviti Pharmaceuticals Pvt.

Ltd. Telangana – 502307, INDIA. M.L.

No.: 12/SRD/TS/2017/F/G Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Revised: 03/2025 03011000726

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Trazodone hydrochloride tablets USP, for oral use (traz' oh done hye'' droe klor' ide) Medication Guide available at https://risingpharma.com/Medguides/Trazodone.pdf 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 cancause other symptoms. Antidepressants are medicines used to treat depression and other illnesses.

It is important to discuss all the risks of treating depression andalso the risks of not treating it. You should discuss all treatment choiceswith 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 is safe and effective in children.

What are trazodone hydrochloride tablets? Trazodone hydrochloride tablets are a prescription medicine used in adults to treat major depressive disorder (MDD). Trazodone 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:…

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