MedPath

Trazodone Hydrochloride

TRAZODONE HYDROCHLORIDE TABLETS, USP

Approved
Approval ID

6b1141e6-f233-4440-87c2-cd349d76d1ec

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 18, 2011

Manufacturers
FDA

MedVantx, Inc.

DUNS: 806427725

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 Code66116-402
Application NumberANDA071523
Product Classification
M
Marketing Category
C73584
G
Generic Name
Trazodone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 21, 2009
FDA Product Classification

INGREDIENTS (6)

CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TRAZODONE HYDROCHLORIDEActive
Quantity: 50 mg in 1 1
Code: 6E8ZO8LRNM
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Trazodone Hydrochloride - FDA Drug Approval Details