Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
PSS World Medical
101822682
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
STAT Rx USA LLC
STAT Rx USA LLC
PSS World Medical
786036330
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
42549-546Application Number
ANDA071258Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
March 9, 2011TrazodoneActive
Code: 6E8ZO8LRNMClass: ACTIBQuantity: 50 mg in 1 1
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT