Quick answers
- What is Trazodone hydrochloride used for?
- The FDA-approved label (Raldesy Tm, Validus Pharmaceuticals LLC, September 1, 2026) says: “RALDESY TM is indicated for the treatment of major depressive disorder (MDD) in adults. RALDESY is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of major depressive disorder (MDD) in adults.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Trazodone hydrochloride have a boxed warning?
- Yes. The FDA label for Raldesy Tm has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Trazodone hydrochloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Trazodone hydrochloride been recalled?
- FDA enforcement reports list 4 recalls of products of this medicine; the newest started August 24, 2026 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Trazodone hydrochloride?
- 38 companies list prescription products of Trazodone hydrochloride in the FDA NDC Directory, including Bryant Ranch Prepack, Remedyrepack Inc. and Aphena Pharma Solutions - Tennessee, LLC.
What Trazodone hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
RALDESY TM is indicated for the treatment of major depressive disorder (MDD) in adults. RALDESY is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of major depressive disorder (MDD) in adults.
— FDA label: Raldesy Tm, Validus Pharmaceuticals LLC, effective September 1, 2026. Read the full label on DailyMed →
The FDA has 100 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
99 of 100 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet · Tablet, film coated · Solution |
|---|---|
| Route | Oral |
| Prescription products | 169 in the FDA NDC Directory |
| Brand names | Raldesy Tm |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| trazodone hydrochloride 10 mg/mL solution | Brand: Raldesy Tm | $1.54–$2.46 per mL 2 packages, lowest to highest |
| trazodone hydrochloride 100 mg tablet | Generic | $0.0503 per tablet |
| trazodone hydrochloride 100 mg tablet, film coated | Generic | $0.0503 per tablet |
| trazodone hydrochloride 150 mg tablet | Generic | $0.0848 per tablet |
| trazodone hydrochloride 300 mg tablet | Generic | $0.4433 per tablet |
| trazodone hydrochloride 50 mg tablet | Generic | $0.0299 per tablet |
| trazodone hydrochloride 50 mg tablet, film coated | Generic | $0.0299 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bryant Ranch Prepack18 products
- Remedyrepack Inc.14 products
- Aphena Pharma Solutions - Tennessee, LLC10 products
- A-S Medication Solutions10 products
- Asclemed USA, Inc.7 products
- Proficient Rx LP6 products
- Zydus Pharmaceuticals USA Inc.6 products
- Zydus Lifesciences Limited6 products
- PD-Rx Pharmaceuticals, Inc.6 products
- Major Pharmaceuticals5 products
- American Health Packaging5 products
- Advanced Rx Pharmacy of Tennessee, LLC4 products
- Aurolife Pharma, LLC4 products
- Torrent Pharmaceuticals Limited4 products
- Accord Healthcare Inc.4 products
- Rising Pharma Holdings, Inc.4 products
- Granules Pharmaceuticals Inc.4 products
- Coupler LLC4 products
- NuCare Pharmaceuticals, Inc.4 products
- Apotex Corp.4 products
- Teva Pharmaceuticals USA, Inc.4 products
- AvKARE3 products
- Preferred Pharmaceuticals Inc.3 products
- NCS HealthCare of KY, LLC dba Vangard Labs3 products
- Northwind Health Company, LLC3 products
- Sun Pharmaceutical Industries, Inc.3 products
- Direct_Rx2 products
- Advanced Rx of Tennessee, LLC2 products
- Unit Dose Solutions, Inc.2 products
- Golden State Medical Supply, Inc.2 products
- Cardinal Health 107, LLC2 products
- Oxford Pharmaceuticals, LLC2 products
- St. Mary's Medical Park Pharmacy2 products
- Medsource Pharmaceuticals2 products
- TruPharma, LLC2 products
- Validus Pharmaceuticals LLC1 product
- NuCare Pharmceuticals, Inc.1 product
- AvPAK1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA218637 RALDESY | Kamat | November 26, 2024 | 2, latest November 13, 2025 2025: Labeling · 2025: Labeling |
Generic approvals (14)
- ANDA071196Apotex Inc · March 25, 1987
- ANDA071258Apotex · March 25, 1987
- ANDA071523Teva Pharms USA · December 11, 1987
- ANDA071524Teva Pharms USA · December 11, 1987
- ANDA071525Pliva · March 9, 1988
- ANDA072192Oxford Pharms · February 2, 1989
- ANDA072193Oxford Pharms · February 2, 1989
- ANDA073137Sun Pharm Industries · March 24, 1993
- ANDA202180Torrent · November 27, 2013
- ANDA206923Accord Hlthcare · September 8, 2017
- ANDA205253Zydus Pharms · October 10, 2017
- ANDA204852Aurobindo Pharma · February 5, 2020
- ANDA218988Granules · August 8, 2024
- ANDA217740Graviti Pharms · August 27, 2024
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
August 24, 2026 · Class II · Ongoing · D-0834-2026
Presence of Foreign Tablets/Capsules
traZODone Hydrochloride Tablets, USP, 50 mg, Rx only, 100 Tablets, Manufactured in Croatia By: Pliva Hrvatska d.o.o, Zagreb, Croatia, Manufactured For: Teva Pharmaceuticals, Parsippany, NJ 07054, NDC 50111-560-01 — Teva Pharmaceuticals USA, Inc
-
January 26, 2026 · Class II · Ongoing · D-0305-2026
Presence of Foreign Tablets/Capsules
Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only, Manufactured by: Granules India Limited, Hyderabad, 500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-231-01. — Granules Pharmaceuticals Inc.
-
December 19, 2025 · Class III · Ongoing · D-0247-2026
Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.
traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufactured by: Zydus Lifesciences Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-806-10 — Zydus Pharmaceuticals (USA) Inc
-
March 15, 2021 · Class II · Terminated · D-0510-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
TRAZODONE HYDROCHLORIDE TABLETS, USP 50MG 100 TABLET 10X10UD; NDC/UPC 0904-6868-61; RX; TABLETS — Cardinal Health Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Raldesy Tm, Validus Pharmaceuticals LLC, effective September 1, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →