Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Aphena Pharma Solutions - Tennessee, LLC
Aphena Pharma Solutions - Tennessee, LLC
128385585
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Prazosin Hydrochloride
Product Details
NDC Product Code
43353-868Application Number
ANDA072575Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
April 3, 2014LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
PrazosinActive
Code: X0Z7454B90Class: ACTIMQuantity: 2 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NHClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT