Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
NCS HealthCare of KY, LLC dba Vangard Labs
NCS HealthCare of KY, LLC dba Vangard Labs
050052943
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
0615-8339Application Number
ANDA071525Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 24, 2023SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
TrazodoneActive
Code: 6E8ZO8LRNMClass: ACTIBQuantity: 150 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
Trazodone Hydrochloride
Product Details
NDC Product Code
0615-8371Application Number
ANDA071523Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 24, 2023TrazodoneActive
Code: 6E8ZO8LRNMClass: ACTIBQuantity: 50 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT