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FDA Approval

Trazodone Hydrochloride

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
February 14, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Trazodone(100 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Quality Care Products, LLC

Quality Care Products, LLC

831276758

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Trazodone Hydrochloride

Product Details

NDC Product Code
55700-855
Application Number
ANDA205253
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
September 16, 2021
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
TrazodoneActive
Code: 6E8ZO8LRNMClass: ACTIBQuantity: 100 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
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