MedPath

FLAVOXATE HYDROCHLORIDE

Flavoxate HCl Tablets 100 mg

Approved
Approval ID

4c4470d2-4e62-4cce-af3c-113b6be7d986

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 24, 2014

Manufacturers
FDA

Carilion Materials Management

DUNS: 079239644

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 Code68151-3826
Application NumberANDA076831
Product Classification
M
Marketing Category
C73584
G
Generic Name
FLAVOXATE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateJuly 24, 2014
FDA Product Classification

INGREDIENTS (12)

FLAVOXATE HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: 9C05J6089W
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ETHYL ACRYLATEInactive
Code: 71E6178C9T
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
METHYL METHACRYLATEInactive
Code: 196OC77688
Classification: IACT
NONOXYNOL-100Inactive
Code: A906T4D368
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT

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