FDA.reportPublic FDA data

Fluvoxamine Maleate

Product NDC
0228-2848
11-digit product format
002282848
Labeler code
0228
Product ID
0228-2848_b051dd36-d5c1-48f0-93d9-1d6fae21b16f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluvoxamine Maleate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA091482
Marketing category
ANDA
Marketing start
2014-08-05
Substance
FLUVOXAMINE MALEATE
Active strength
100 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 MALEATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5LGN83G74V
Rxcui903873, 903879

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0228-2848-03Fluvoxamine Maleate30 in 1 BOTTLECAPSULE, EXTENDED RELEASE3021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0228-2848-03EA - Each0228-28487532e674-c08c-4347-aa6b-87ecc74faa4812014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUVOXAMINE MALEATEACTIVE INGREDIENT5LGN83G74VFLUVOXAMINE MALEATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]9
FLUVOXAMINEACTIVE MOIETYO4L1XPO44WFLUVOXAMINE MALEATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]9
AMMONIO METHACRYLATE COPOLYMER TYPE AINACTIVE INGREDIENT8GQS4E66YYFLUVOXAMINE MALEATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]9
AMMONIO METHACRYLATE COPOLYMER TYPE BINACTIVE INGREDIENT161H3B14U2FLUVOXAMINE MALEATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]9
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDFLUVOXAMINE MALEATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]9
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTFLUVOXAMINE MALEATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]9
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357FLUVOXAMINE MALEATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]9
GELATININACTIVE INGREDIENT2G86QN327LFLUVOXAMINE MALEATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]9
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PFLUVOXAMINE MALEATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]9
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TFLUVOXAMINE MALEATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]9
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3FLUVOXAMINE MALEATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]9
SHELLACINACTIVE INGREDIENT46N107B71OFLUVOXAMINE MALEATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]9
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JFLUVOXAMINE MALEATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]9
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFLUVOXAMINE MALEATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]9
SUCROSEINACTIVE INGREDIENTC151H8M554FLUVOXAMINE MALEATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]9
TALCINACTIVE INGREDIENT7SEV7J4R1UFLUVOXAMINE MALEATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]9
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFLUVOXAMINE MALEATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]9
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMFLUVOXAMINE MALEATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0228-2848FLUVOXAMINE MALEATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]19Current NDC, Legacy NDC, 1 package rows20250516_8bbd7e39-b9ab-4716-9522-aa8c4b92210e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
903873fluvoxaMINE maleate 100 MG 24HR Extended Release Oral CapsulePSN8bbd7e39-b9ab-4716-9522-aa8c4b92210e21
903879fluvoxaMINE maleate 150 MG 24HR Extended Release Oral CapsulePSN8bbd7e39-b9ab-4716-9522-aa8c4b92210e21
90387324 HR fluvoxamine maleate 100 MG Extended Release Oral CapsuleSCD8bbd7e39-b9ab-4716-9522-aa8c4b92210e21
90387924 HR fluvoxamine maleate 150 MG Extended Release Oral CapsuleSCD8bbd7e39-b9ab-4716-9522-aa8c4b92210e21
903873fluvoxamine maleate 100 MG 24 HR Extended Release Oral CapsuleSY8bbd7e39-b9ab-4716-9522-aa8c4b92210e21
903879fluvoxamine maleate 150 MG 24 HR Extended Release Oral CapsuleSY8bbd7e39-b9ab-4716-9522-aa8c4b92210e21
903873fluvoxaMINE maleate 100 MG 24HR Extended Release Oral CapsulePSN4527a684-51c0-1858-e063-6394a90a26311
903879fluvoxaMINE maleate 150 MG 24HR Extended Release Oral CapsulePSN4527a684-51c0-1858-e063-6394a90a26311
90387324 HR fluvoxamine maleate 100 MG Extended Release Oral CapsuleSCD4527a684-51c0-1858-e063-6394a90a26311
90387924 HR fluvoxamine maleate 150 MG Extended Release Oral CapsuleSCD4527a684-51c0-1858-e063-6394a90a26311
903873fluvoxamine maleate 100 MG 24 HR Extended Release Oral CapsuleSY4527a684-51c0-1858-e063-6394a90a26311
903879fluvoxamine maleate 150 MG 24 HR Extended Release Oral CapsuleSY4527a684-51c0-1858-e063-6394a90a26311

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0228-2848-030022828480330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0228-2848-03) 2014-08-050000-00-00NoNoCurrent