Flavoxate Hydrochloride
Flavoxate Hydrochloride Tablets, 100 mg Film-Coated
Approved
Approval ID
e05f4892-0be8-4178-a274-3289edca0137
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 25, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Flavoxate hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-6326
Application NumberANDA076835
Product Classification
M
Marketing Category
C73584
G
Generic Name
Flavoxate hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 25, 2012
FDA Product Classification
INGREDIENTS (9)
dibasic calcium phosphate dihydrateInactive
Code: O7TSZ97GEP
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
Flavoxate hydrochlorideActive
Quantity: 100 mg in 1 1
Code: 9C05J6089W
Classification: ACTIB
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
hypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
polydextroseInactive
Code: VH2XOU12IE
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
triacetinInactive
Code: XHX3C3X673
Classification: IACT