Terazosin Hydrochloride

Manufacturing Establishments1

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

A-S Medication Solutions

Labeler

A-S Medication Solutions

DUNS Number

830016429

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

50090-1943

Application Number

ANDA074823

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

February 28, 2019

Ingredients

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

D&C RED NO. 28Inactive

Code: 767IP0Y5NHClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

TerazosinActive

Code: D32S14F082Class: ACTIMQuantity: 5 mg in 1 1

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

CROSPOVIDONE (15 MPA.S AT 5%)Inactive

Code: 68401960MKClass: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQKClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT