fluvoxamine maleate

Product NDC
33261-683
11-digit product format
332610683
Labeler code
33261
Product ID
33261-683_c52564a5-732a-4f66-803b-4a3d55d53306
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluvoxamine maleate
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
NDA021519
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2011-08-09
Marketing end
0000-00-00
Substance
FLUVOXAMINE MALEATE
Active strength
50 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cf9608ac-e3cb-2ff5-9afb-dc9a0d25234dProduct name320250515
0b12fd59-0eda-41d5-8618-6195bcd36a86Product name120250114

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-683-30fluvoxamine maleate30 in 1 BOTTLE, PLASTICTABLET, COATED301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-683-30EA - Each33261-683eb0f8233-8c59-4dd0-b519-5a0029f3634612015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUVOXAMINE MALEATEACTIVE INGREDIENT5LGN83G74VFLUVOXAMINE MALEATE TABLET, COATED [AIDAREX PHARMACEUTICALS LLC]1
FLUVOXAMINEACTIVE MOIETYO4L1XPO44WFLUVOXAMINE MALEATE TABLET, COATED [AIDAREX PHARMACEUTICALS LLC]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZFLUVOXAMINE MALEATE TABLET, COATED [AIDAREX PHARMACEUTICALS LLC]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTFLUVOXAMINE MALEATE TABLET, COATED [AIDAREX PHARMACEUTICALS LLC]1
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82FLUVOXAMINE MALEATE TABLET, COATED [AIDAREX PHARMACEUTICALS LLC]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6FLUVOXAMINE MALEATE TABLET, COATED [AIDAREX PHARMACEUTICALS LLC]1
MANNITOLINACTIVE INGREDIENT3OWL53L36AFLUVOXAMINE MALEATE TABLET, COATED [AIDAREX PHARMACEUTICALS LLC]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQFLUVOXAMINE MALEATE TABLET, COATED [AIDAREX PHARMACEUTICALS LLC]1
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BFLUVOXAMINE MALEATE TABLET, COATED [AIDAREX PHARMACEUTICALS LLC]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HFLUVOXAMINE MALEATE TABLET, COATED [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FLUVOXAMINE MALEATE TABLET, COATED [AIDAREX PHARMACEUTICALS LLC]1
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIFLUVOXAMINE MALEATE TABLET, COATED [AIDAREX PHARMACEUTICALS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFLUVOXAMINE MALEATE TABLET, COATED [AIDAREX PHARMACEUTICALS LLC]1
STARCH, POTATOINACTIVE INGREDIENT8I089SAH3TFLUVOXAMINE MALEATE TABLET, COATED [AIDAREX PHARMACEUTICALS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFLUVOXAMINE MALEATE TABLET, COATED [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-683FLUVOXAMINE MALEATE TABLET, COATED [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 1 package rows20140110_ee2aa73e-7b14-4d64-94a7-d843e08d5d77.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
903891fluvoxaMINE maleate 50 MG Oral TabletPSNee2aa73e-7b14-4d64-94a7-d843e08d5d771
903891fluvoxamine maleate 50 MG Oral TabletSCDee2aa73e-7b14-4d64-94a7-d843e08d5d771

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-683-303326106833030 in 1 BOTTLE, PLASTICHistorical