Trazodone Hydrochloride
TRAZODONE HYDROCHLORIDE TABLETS, USP
Approved
Approval ID
911802e4-2aeb-4447-99ae-6029cdd2d7dd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 17, 2010
Manufacturers
FDA
Keltman Pharmaceuticals Inc.
DUNS: 362861077
Products 2
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 Code68387-166
Application NumberANDA072193
Product Classification
M
Marketing Category
C73584
G
Generic Name
Trazodone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 17, 2010
FDA Product Classification
INGREDIENTS (10)
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TRAZODONE HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: 6E8ZO8LRNM
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
Trazodone Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68387-165
Application NumberANDA072192
Product Classification
M
Marketing Category
C73584
G
Generic Name
Trazodone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 17, 2010
FDA Product Classification
INGREDIENTS (10)
TRAZODONE HYDROCHLORIDEActive
Quantity: 50 mg in 1 1
Code: 6E8ZO8LRNM
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT