Trazodone Hydrochloride
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use TRAZODONE hydrochloride tablets USP safely and effectively. See full prescribing information for TRAZODONE hydrochloride tablets USP. TRAZODONE hydrochloride tablets USP, for oral useInitial U.S. Approval: 1981
Approved
Approval ID
8ab02532-35f7-4f99-941b-bc49eff1e8ae
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 1, 2020
Manufacturers
FDA
Proficient Rx LP
DUNS: 079196022
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 Code63187-086
Application NumberANDA071523
Product Classification
M
Marketing Category
C73584
G
Generic Name
Trazodone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 1, 2020
FDA Product Classification
INGREDIENTS (6)
TRAZODONE HYDROCHLORIDEActive
Quantity: 50 mg in 1 1
Code: 6E8ZO8LRNM
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Trazodone Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63187-133
Application NumberANDA071524
Product Classification
M
Marketing Category
C73584
G
Generic Name
Trazodone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 1, 2020
FDA Product Classification
INGREDIENTS (6)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TRAZODONE HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: 6E8ZO8LRNM
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT