Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
DIRECT RX
DIRECT RX
079254320
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
doxepin hydrochloride
Product Details
NDC Product Code
61919-081Application Number
ANDA070791Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 5, 2015DoxepinActive
Code: 3U9A0FE9N5Class: ACTIMQuantity: 50 mg in 1 1
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT