FDA.reportPublic FDA data

FLAVOXATE HYDROCHLORIDE

Product NDC
0574-0115
11-digit product format
005740115
Labeler code
0574
Product ID
0574-0115_ff1c0ee9-75d2-478a-9152-0753be81ff11
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FLAVOXATE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Padagis US LLC
Application
ANDA076831
Marketing category
ANDA
Marketing start
2004-12-22
Marketing end
2026-12-31
Substance
FLAVOXATE HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
FLAVOXATE HYDROCHLORIDE

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLAVOXATE HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9C05J6089W
Rxcui1095229

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0574-0115-01FLAVOXATE HYDROCHLORIDE100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0574-0115-01EA - Each0574-0115e964f736-e2cf-49c5-8d41-dc7beb3e3b8d12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLAVOXATE HYDROCHLORIDEACTIVE INGREDIENT9C05J6089WFLAVOXATE HYDROCHLORIDE TABLET, FILM COATED [PADDOCK LABORATORIES, LLC]7
FLAVOXATEACTIVE MOIETY3E74Y80MEYFLAVOXATE HYDROCHLORIDE TABLET, FILM COATED [PADDOCK LABORATORIES, LLC]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFLAVOXATE HYDROCHLORIDE TABLET, FILM COATED [PADDOCK LABORATORIES, LLC]7
ETHYL ACRYLATEINACTIVE INGREDIENT71E6178C9TFLAVOXATE HYDROCHLORIDE TABLET, FILM COATED [PADDOCK LABORATORIES, LLC]7
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6FLAVOXATE HYDROCHLORIDE TABLET, FILM COATED [PADDOCK LABORATORIES, LLC]7
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFLAVOXATE HYDROCHLORIDE TABLET, FILM COATED [PADDOCK LABORATORIES, LLC]7
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFLAVOXATE HYDROCHLORIDE TABLET, FILM COATED [PADDOCK LABORATORIES, LLC]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FLAVOXATE HYDROCHLORIDE TABLET, FILM COATED [PADDOCK LABORATORIES, LLC]7
METHYL METHACRYLATEINACTIVE INGREDIENT196OC77688FLAVOXATE HYDROCHLORIDE TABLET, FILM COATED [PADDOCK LABORATORIES, LLC]7
NONOXYNOL-100INACTIVE INGREDIENTA906T4D368FLAVOXATE HYDROCHLORIDE TABLET, FILM COATED [PADDOCK LABORATORIES, LLC]7
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AFLAVOXATE HYDROCHLORIDE TABLET, FILM COATED [PADDOCK LABORATORIES, LLC]7
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FLAVOXATE HYDROCHLORIDE TABLET, FILM COATED [PADDOCK LABORATORIES, LLC]7
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2FLAVOXATE HYDROCHLORIDE TABLET, FILM COATED [PADDOCK LABORATORIES, LLC]7
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
0574-0115FLAVOXATE HYDROCHLORIDE TABLET, FILM COATED [PADAGIS US LLC]11Current NDC, Legacy NDC, 1 package rows20240202_a9c44c4b-5b3c-45bf-9bc9-ce858e3d06c5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1095229flavoxATE HCl 100 MG Oral TabletPSNa9c44c4b-5b3c-45bf-9bc9-ce858e3d06c512
1095229flavoxate hydrochloride 100 MG Oral TabletSCDa9c44c4b-5b3c-45bf-9bc9-ce858e3d06c512
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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0574-0115-0100574011501100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0574-0115-01) 2004-12-222026-12-31NoNoCurrent