FDA.reportPublic FDA data

FLAVOXATE HYDROCHLORIDE

Product NDC
68151-3826
11-digit product format
681513826
Labeler code
68151
Product ID
68151-3826_d19ab868-f012-410e-ac35-48e6b33433f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FLAVOXATE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Carilion Materials Management
Application
ANDA076831
Marketing category
ANDA
Marketing start
2004-12-22
Marketing end
0000-00-00
Substance
FLAVOXATE HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68151-3826-02020-01-31C16284748780-19d75b9cf-efde-f424-e053-dadaa90a57ceFlavoxate HCl Tablets 100 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68151-3826-0FLAVOXATE HYDROCHLORIDE1 in 1 PACKAGETABLET, FILM COATED12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLAVOXATE HYDROCHLORIDEACTIVE INGREDIENT9C05J6089WFLAVOXATE HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
FLAVOXATEACTIVE MOIETY3E74Y80MEYFLAVOXATE HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFLAVOXATE HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
ETHYL ACRYLATEINACTIVE INGREDIENT71E6178C9TFLAVOXATE HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6FLAVOXATE HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFLAVOXATE HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFLAVOXATE HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FLAVOXATE HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
METHYL METHACRYLATEINACTIVE INGREDIENT196OC77688FLAVOXATE HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
NONOXYNOL-100INACTIVE INGREDIENTA906T4D368FLAVOXATE HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AFLAVOXATE HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FLAVOXATE HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2FLAVOXATE HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-3826FLAVOXATE HYDROCHLORIDE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2Legacy NDC, 1 package rows20140815_4c4470d2-4e62-4cce-af3c-113b6be7d986.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1095229flavoxATE HCl 100 MG Oral TabletPSN4c4470d2-4e62-4cce-af3c-113b6be7d9862
1095229flavoxate hydrochloride 100 MG Oral TabletSCD4c4470d2-4e62-4cce-af3c-113b6be7d9862

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68151-3826-0681513826001 in 1 PACKAGEHistorical