Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Carilion Materials Management
079239644
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Carilion Materials Management
Carilion Materials Management
Carilion Materials Management
079239644
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
68151-2825Application Number
ANDA071523Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 26, 2009MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TrazodoneActive
Code: 6E8ZO8LRNMClass: ACTIBQuantity: 50 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
Trazodone Hydrochloride
Product Details
NDC Product Code
68151-2696Application Number
ANDA071525Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 26, 2009CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
TrazodoneActive
Code: 6E8ZO8LRNMClass: ACTIBQuantity: 150 mg in 1 1
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT