FDA Orange Book · active-ingredient family
Trazodone hydrochloride
Trazodone hydrochloride: 3 brands, 33 generics; first approved Mar 25, 1985; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 33 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
3
Generics (ANDA)
33
Listed patents
2
Next patent expiry
Mar 27, 2027
in 6 mo
Brand (NDA) products
Originator applications
- KAMATNDA 2186372024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML SOLUTION ORAL Rx — - OLEPTRORLDANGELINI PHARMANDA 02241120102 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET, EXTENDED RELEASE ORAL Discontinued — 300MG TABLET, EXTENDED RELEASE ORAL Discontinued — - DESYRELRLDPRAGMANDA 018207—4 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — 150MG TABLET ORAL Discontinued — 300MG TABLET ORAL Discontinued —
Generic (ANDA) products (33)
Abbreviated applications
- TRAZODONE HYDROCHLORIDERSOXFORD PHARMSANDA 07219320263 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Rx AB 25MG TABLET ORAL Rx — 75MG TABLET ORAL Rx — - TRAZODONE HYDROCHLORIDEGRAVITI PHARMSANDA 21774020244 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 150MG TABLET ORAL Rx AB 300MG TABLET ORAL Rx AB - TRAZODONE HYDROCHLORIDEGRANULESANDA 21898820244 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 150MG TABLET ORAL Rx AB 300MG TABLET ORAL Rx AB - TRAZODONE HYDROCHLORIDECROSSMEDIKA SAANDA 21111620244 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 150MG TABLET ORAL Rx AB 300MG TABLET ORAL Rx AB - TRAZODONE HYDROCHLORIDEAUROBINDO PHARMAANDA 20485220204 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 150MG TABLET ORAL Rx AB 300MG TABLET ORAL Rx AB - TRAZODONE HYDROCHLORIDEZYDUS PHARMSANDA 20525320174 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 150MG TABLET ORAL Rx AB 300MG TABLET ORAL Rx AB - TRAZODONE HYDROCHLORIDEACCORD HLTHCAREANDA 20692320174 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 150MG TABLET ORAL Rx AB 300MG TABLET ORAL Rx AB - TRAZODONE HYDROCHLORIDETORRENTANDA 20218020134 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 150MG TABLET ORAL Rx AB 300MG TABLET ORAL Rx AB - TRAZODONE HYDROCHLORIDEPHARMOBEDIENTANDA 09051420094 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — 150MG TABLET ORAL Discontinued — 300MG TABLET ORAL Discontinued — - TRAZODONE HYDROCHLORIDETEVAANDA 0743571997
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET ORAL Discontinued — - TRAZODONE HYDROCHLORIDESUN PHARM INDUSTRIESANDA 07313719933 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 150MG TABLET ORAL Rx AB - TRAZODONE HYDROCHLORIDENATCOANDA 0714051991
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - TRAZODONE HYDROCHLORIDENATCOANDA 0714061991
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — - TRAZODONE HYDROCHLORIDEAIPING PHARM INCANDA 0724831990
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — - TRAZODONE HYDROCHLORIDERISINGANDA 0724841990
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - TRAZODONE HYDROCHLORIDEOXFORD PHARMSANDA 0721921989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB - TRAZODONE HYDROCHLORIDEALVOGENANDA 0716361988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - TRAZODONE HYDROCHLORIDEALVOGENANDA 0715141988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — - TRAZODONE HYDROCHLORIDEPLIVAANDA 0715251988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 150MG TABLET ORAL Rx AB - TRAZODONE HYDROCHLORIDETEVA PHARMS USAANDA 0715231987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB - TRAZODONE HYDROCHLORIDETEVA PHARMS USAANDA 0715241987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Rx AB - TRAZODONE HYDROCHLORIDEUSL PHARMAANDA 0704911987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - TRAZODONE HYDROCHLORIDEUSL PHARMAANDA 0704921987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — - TRAZODONE HYDROCHLORIDEAPOTEXANDA 0712581987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB - TRAZODONE HYDROCHLORIDERSAPOTEX INCANDA 07119619873 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Rx AB 150MG TABLET ORAL Rx AB 300MG TABLET ORAL Rx AB - TRAZODONE HYDROCHLORIDEQUANTUM PHARMICSANDA 0709211986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — - QUANTUM PHARMICSANDA 0709421986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - TRAZODONE HYDROCHLORIDEWATSON LABSANDA 0711121986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - TRAZODONE HYDROCHLORIDEWATSON LABSANDA 0711131986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — - TRAZODONE HYDROCHLORIDEAM THERAPANDA 0711391986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - TRAZODONE HYDROCHLORIDEAM THERAPANDA 0711401986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — - TRAZODONE HYDROCHLORIDEWATSON LABSANDA 0708571986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - TRAZODONE HYDROCHLORIDEWATSON LABSANDA 0708581986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 7829120 | in 6 mo | ProductU-796 | |
| 8133893 | in 2 yr 6 mo | SubstanceProduct |
Approval history
FDA approval span
First approval
42 yr 1 mo ago
Most recent approval
21 d ago
Approvals span 1985–2026 across 36 FDA applications.
Brand (NDA) 38%
Generic (ANDA) 3392%
Trazodone hydrochloride: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
