FDA.reportPublic FDA data

Fluvoxamine Maleate

Product NDC
60505-0165
11-digit product format
605050165
Labeler code
60505
Product ID
60505-0165_d1dc7389-27a2-60cd-7d33-9f0dd29a95b4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluvoxamine Maleate
Dosage form
TABLET
Route
ORAL
Labeler
Apotex Corp
Application
ANDA075902
Marketing category
ANDA
Marketing start
2001-07-10
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
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 MALEATE50 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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60505-0165-1Fluvoxamine Maleate100 in 1 BOTTLETABLET10015
60505-0165-2Fluvoxamine Maleate1000 in 1 BOTTLETABLET100015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-0165-1EA - Each60505-0165469a9279-b09d-44ce-ba3b-cbaf62c92cfe12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUVOXAMINE MALEATEACTIVE INGREDIENT5LGN83G74VFLUVOXAMINE MALEATE TABLET [APOTEX CORP]6
FLUVOXAMINEACTIVE MOIETYO4L1XPO44WFLUVOXAMINE MALEATE TABLET [APOTEX CORP]6
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675FLUVOXAMINE MALEATE TABLET [APOTEX CORP]6
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTFLUVOXAMINE MALEATE TABLET [APOTEX CORP]6
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357FLUVOXAMINE MALEATE TABLET [APOTEX CORP]6
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)INACTIVE INGREDIENT8136Y38GY5FLUVOXAMINE MALEATE TABLET [APOTEX CORP]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FLUVOXAMINE MALEATE TABLET [APOTEX CORP]6
MANNITOLINACTIVE INGREDIENT3OWL53L36AFLUVOXAMINE MALEATE TABLET [APOTEX CORP]6
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BFLUVOXAMINE MALEATE TABLET [APOTEX CORP]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFLUVOXAMINE MALEATE TABLET [APOTEX CORP]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-0165FLUVOXAMINE MALEATE TABLET [APOTEX CORP]14Current NDC, Legacy NDC, 2 package rows20240214_6eeb14df-6fcf-a737-5359-5744eb4accea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
903891fluvoxaMINE maleate 50 MG Oral TabletPSN47daea9e-545d-4a67-b2b2-d12c3c98734b103
903891fluvoxamine maleate 50 MG Oral TabletSCD47daea9e-545d-4a67-b2b2-d12c3c98734b103
903884fluvoxaMINE maleate 100 MG Oral TabletPSN6eeb14df-6fcf-a737-5359-5744eb4accea15
903887fluvoxaMINE maleate 25 MG Oral TabletPSN6eeb14df-6fcf-a737-5359-5744eb4accea15
903891fluvoxaMINE maleate 50 MG Oral TabletPSN6eeb14df-6fcf-a737-5359-5744eb4accea15
903884fluvoxamine maleate 100 MG Oral TabletSCD6eeb14df-6fcf-a737-5359-5744eb4accea15
903887fluvoxamine maleate 25 MG Oral TabletSCD6eeb14df-6fcf-a737-5359-5744eb4accea15
903891fluvoxamine maleate 50 MG Oral TabletSCD6eeb14df-6fcf-a737-5359-5744eb4accea15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60505-0165-160505016501100 TABLET in 1 BOTTLE (60505-0165-1) 100 tablet2001-07-100000-00-00NoNoCurrent
60505-0165-2605050165021000 TABLET in 1 BOTTLE (60505-0165-2) 1000 tablet2001-07-100000-00-00NoNoCurrent