Trazodone Hydrochloride
TRAZODONE HYDROCHLORIDE TABLETS, USP
Approved
Approval ID
49196e9e-aeef-4663-8be9-6b523ae7fb7a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 14, 2012
Manufacturers
FDA
STAT Rx USA LLC
DUNS: 786036330
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 Code42549-546
Application NumberANDA071258
Product Classification
M
Marketing Category
C73584
G
Generic Name
Trazodone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMarch 9, 2011
FDA Product Classification
INGREDIENTS (7)
TRAZODONE HYDROCHLORIDEActive
Quantity: 50 mg in 1 1
Code: 6E8ZO8LRNM
Classification: ACTIB
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT