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
22f6618e-82ae-4474-a472-d966222d8ffb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 14, 2023
Manufacturers
FDA
Quality Care Products, LLC
DUNS: 831276758
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 Code55700-855
Application NumberANDA205253
Product Classification
M
Marketing Category
C73584
G
Generic Name
Trazodone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 16, 2021
FDA Product Classification
INGREDIENTS (7)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TRAZODONE HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: 6E8ZO8LRNM
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT