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Trazodone Hydrochloride

TRAZODONE HYDROCHLORIDE TABLETS, USP

Approved
Approval ID

af82c9b0-1c3a-407a-aa5d-f15b9217b5c6

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 8, 2011

Manufacturers
FDA

Blenheim Pharmacal, Inc.

DUNS: 171434587

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 Code10544-533
Application NumberANDA071525
Product Classification
M
Marketing Category
C73584
G
Generic Name
Trazodone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJune 8, 2011
FDA Product Classification

INGREDIENTS (6)

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TRAZODONE HYDROCHLORIDEActive
Quantity: 150 mg in 1 1
Code: 6E8ZO8LRNM
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT

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Trazodone Hydrochloride - FDA Drug Approval Details