MedPath
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 7, 2022
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Trazodone(50 mg in 1 1)

Manufacturing Establishments1

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

NuCare Pharmaceuticals,Inc.

NuCare Pharmaceuticals,Inc.

010632300

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
68071-5187
Application Number
ANDA206923
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
February 7, 2022
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
TrazodoneActive
Code: 6E8ZO8LRNMClass: ACTIBQuantity: 50 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
© Copyright 2025. All Rights Reserved by MedPath