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.
Approved
Approval ID
ed3039d8-3d27-4b71-a4b0-812943c9457f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 20, 2024
Manufacturers
FDA
Accord Healthcare, Inc.
DUNS: 604222237
Products 4
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 Code16729-302
Application NumberANDA206923
Product Classification
M
Marketing Category
C73584
G
Generic Name
Trazodone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 20, 2024
FDA Product Classification
INGREDIENTS (6)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TRAZODONE HYDROCHLORIDEActive
Quantity: 300 mg in 1 1
Code: 6E8ZO8LRNM
Classification: ACTIB
Trazodone Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16729-299
Application NumberANDA206923
Product Classification
M
Marketing Category
C73584
G
Generic Name
Trazodone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 20, 2024
FDA Product Classification
INGREDIENTS (6)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TRAZODONE HYDROCHLORIDEActive
Quantity: 50 mg in 1 1
Code: 6E8ZO8LRNM
Classification: ACTIB
Trazodone Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16729-301
Application NumberANDA206923
Product Classification
M
Marketing Category
C73584
G
Generic Name
Trazodone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 20, 2024
FDA Product Classification
INGREDIENTS (6)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TRAZODONE HYDROCHLORIDEActive
Quantity: 150 mg in 1 1
Code: 6E8ZO8LRNM
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
Trazodone Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16729-300
Application NumberANDA206923
Product Classification
M
Marketing Category
C73584
G
Generic Name
Trazodone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 20, 2024
FDA Product Classification
INGREDIENTS (6)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TRAZODONE HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: 6E8ZO8LRNM
Classification: ACTIB