Trazodone Hydrochloride
These highlights do not include all the information needed to use TRAZODONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAZODONE HYDROCHLORIDE TABLETS. TRAZODONE HYDROCHLORIDE tablets, for oral useInitial U.S. Approval: 1981
Approved
Approval ID
88ac1a9d-8483-4b29-9fe6-2e60e51f3005
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 1, 2021
Manufacturers
FDA
Proficient Rx LP
DUNS: 079196022
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Trazodone Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71205-551
Application NumberANDA205253
Product Classification
M
Marketing Category
C73584
G
Generic Name
Trazodone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 1, 2021
FDA Product Classification
INGREDIENTS (7)
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TRAZODONE HYDROCHLORIDEActive
Quantity: 50 mg in 1 1
Code: 6E8ZO8LRNM
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT