Flavoxate Hydrochloride
Flavoxate Hydrochloride Tablets 100 mg, Film-Coated Rx only
Approved
Approval ID
f6a06eda-2480-4c0d-8d1e-9e3e89d3ee88
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 9, 2021
Manufacturers
FDA
PuraCap Laboratories LLC dba Blu Pharmaceuticals
DUNS: 080210964
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 Code24658-720
Application NumberANDA076835
Product Classification
M
Marketing Category
C73584
G
Generic Name
Flavoxate Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 21, 2017
FDA Product Classification
INGREDIENTS (10)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSE 2910 (50 MPA.S)Inactive
Code: 1IVH67816N
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FLAVOXATE HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: 9C05J6089W
Classification: ACTIB