FDA.reportPublic FDA data

fluvoxamine maleate

Product NDC
62559-158
11-digit product format
625590158
Labeler code
62559
Product ID
62559-158_cfb2098d-d30b-4a8e-84c1-aeb8065b519c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluvoxamine maleate
Dosage form
TABLET, COATED
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
NDA021519
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2011-08-09
Substance
FLUVOXAMINE MALEATE
Active strength
25 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
fluvoxamine maleate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUVOXAMINE MALEATE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5LGN83G74V
Rxcui903884, 903887, 903891

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cf9608ac-e3cb-2ff5-9afb-dc9a0d25234dProduct name320250515
0b12fd59-0eda-41d5-8618-6195bcd36a86Product name120250114
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62559-158-01fluvoxamine maleate100 in 1 BOTTLETABLET, COATED10016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62559-158-01EA - Each62559-1587d0a3773-c2f2-4136-82b9-f12bf0e7785c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUVOXAMINE MALEATEACTIVE INGREDIENT5LGN83G74VFLUVOXAMINE MALEATE TABLET, COATED [ANI PHARMACEUTICALS, INC.]5
FLUVOXAMINEACTIVE MOIETYO4L1XPO44WFLUVOXAMINE MALEATE TABLET, COATED [ANI PHARMACEUTICALS, INC.]5
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZFLUVOXAMINE MALEATE TABLET, COATED [ANI PHARMACEUTICALS, INC.]5
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675FLUVOXAMINE MALEATE TABLET, COATED [ANI PHARMACEUTICALS, INC.]5
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTFLUVOXAMINE MALEATE TABLET, COATED [ANI PHARMACEUTICALS, INC.]5
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357FLUVOXAMINE MALEATE TABLET, COATED [ANI PHARMACEUTICALS, INC.]5
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82FLUVOXAMINE MALEATE TABLET, COATED [ANI PHARMACEUTICALS, INC.]5
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6FLUVOXAMINE MALEATE TABLET, COATED [ANI PHARMACEUTICALS, INC.]5
MANNITOLINACTIVE INGREDIENT3OWL53L36AFLUVOXAMINE MALEATE TABLET, COATED [ANI PHARMACEUTICALS, INC.]5
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQFLUVOXAMINE MALEATE TABLET, COATED [ANI PHARMACEUTICALS, INC.]5
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BFLUVOXAMINE MALEATE TABLET, COATED [ANI PHARMACEUTICALS, INC.]5
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HFLUVOXAMINE MALEATE TABLET, COATED [ANI PHARMACEUTICALS, INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FLUVOXAMINE MALEATE TABLET, COATED [ANI PHARMACEUTICALS, INC.]5
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIFLUVOXAMINE MALEATE TABLET, COATED [ANI PHARMACEUTICALS, INC.]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFLUVOXAMINE MALEATE TABLET, COATED [ANI PHARMACEUTICALS, INC.]5
STARCH, POTATOINACTIVE INGREDIENT8I089SAH3TFLUVOXAMINE MALEATE TABLET, COATED [ANI PHARMACEUTICALS, INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFLUVOXAMINE MALEATE TABLET, COATED [ANI PHARMACEUTICALS, INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62559-158FLUVOXAMINE MALEATE TABLET, COATED [ANI PHARMACEUTICALS, INC.]15Current NDC, Legacy NDC, 1 package rows20230823_7ecd83ec-88f5-4f85-9cc2-9068375d8820.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
903884fluvoxaMINE maleate 100 MG Oral TabletPSN7ecd83ec-88f5-4f85-9cc2-9068375d882016
903887fluvoxaMINE maleate 25 MG Oral TabletPSN7ecd83ec-88f5-4f85-9cc2-9068375d882016
903891fluvoxaMINE maleate 50 MG Oral TabletPSN7ecd83ec-88f5-4f85-9cc2-9068375d882016
903884fluvoxamine maleate 100 MG Oral TabletSCD7ecd83ec-88f5-4f85-9cc2-9068375d882016
903887fluvoxamine maleate 25 MG Oral TabletSCD7ecd83ec-88f5-4f85-9cc2-9068375d882016
903891fluvoxamine maleate 50 MG Oral TabletSCD7ecd83ec-88f5-4f85-9cc2-9068375d882016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62559-158-0162559015801100 TABLET, COATED in 1 BOTTLE (62559-158-01) 2011-08-090000-00-00NoNoCurrent