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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
Contract Pharmacy Services-PA
DUNS: 945429777
Effective Date
March 9, 2010
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Trazodone(100 mg in 1 1)

Products2

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
67046-741
Application Number
ANDA071524
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
June 1, 2009
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
TrazodoneActive
Code: 6E8ZO8LRNMClass: ACTIMQuantity: 100 mg in 1 1
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT

Trazodone Hydrochloride

Product Details

NDC Product Code
67046-740
Application Number
ANDA071523
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
June 1, 2009
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
TrazodoneActive
Code: 6E8ZO8LRNMClass: ACTIMQuantity: 50 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
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