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Active ingredient

Trazodone

158 finished FDA listings contain Trazodone as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
TRAZODONE, TRAZODONE HYDROCHLORIDE
Dosage forms
Solution, Tablet, Tablet, Film Coated
Routes
Oral
Manufacturers / labelers
38
Strengths listed
10 mg/ml · 100 mg/1 · 150 mg/1 · 25 mg/1 · 300 mg/1 · 50 mg/1 · 75 mg/1
Brand names in FDA listings
Raldesy Tm

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 10737

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
ANDA 071196APOTEX INC1987-03-256
ANDA 071258APOTEX1987-03-252
ANDA 071524TEVA PHARMS USA1987-12-119
ANDA 071523TEVA PHARMS USA1987-12-119
ANDA 071525PLIVA1988-03-094
ANDA 072192OXFORD PHARMS1989-02-021
ANDA 072193OXFORD PHARMS1989-02-023
ANDA 073137SUN PHARM INDUSTRIES1993-03-246
ANDA 202180TORRENT2013-11-2719
ANDA 206923ACCORD HLTHCARE2017-09-087
ANDA 205253ZYDUS PHARMS2017-10-1056
ANDA 204852AUROBINDO PHARMA2020-02-0519
ANDA 218988GRANULES2024-08-0811
ANDA 217740GRAVITI PHARMS2024-08-275
NDA 218637KAMAT2024-11-261

Official labeling on DailyMed

Showing the 12 most recent of 104 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.