Prazosin Hydrochloride

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Coupler Enterprises

Labeler

Contract Pharmacy Services-PA

DUNS Number

945429777

Products2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Product Details

NDC Product Code

67046-208

Application Number

ANDA072575

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

September 21, 2017

Ingredients

GELATINInactive

Code: 2G86QN327LClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

DIMETHICONEInactive

Code: 92RU3N3Y1OClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

PrazosinActive

Code: X0Z7454B90Class: ACTIMQuantity: 2 mg in 1 1

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

D&C RED NO. 28Inactive

Code: 767IP0Y5NHClass: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT