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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
December 3, 2021
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
55700-739
Application Number
ANDA206923
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
December 3, 2021
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
TrazodoneActive
Code: 6E8ZO8LRNMClass: ACTIBQuantity: 100 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
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