Flavoxate Hydrochloride

Manufacturing Establishments1

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

Labeler

Physicians Total Care, Inc.

DUNS Number

194123980

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

NDC Product Code

54868-6326

Application Number

ANDA076835

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 25, 2012

Ingredients

dibasic calcium phosphate dihydrateInactive

Code: O7TSZ97GEPClass: IACT

magnesium stearateInactive

Code: 70097M6I30Class: IACT

Code: 9C05J6089WClass: ACTIBQuantity: 100 mg in 1 1

silicon dioxideInactive

Code: ETJ7Z6XBU4Class: IACT

starch, cornInactive

Code: O8232NY3SJClass: IACT

hypromellosesInactive

Code: 3NXW29V3WOClass: IACT

polydextroseInactive

Code: VH2XOU12IEClass: IACT

titanium dioxideInactive

Code: 15FIX9V2JPClass: IACT

triacetinInactive

Code: XHX3C3X673Class: IACT