FDA.reportPublic FDA data

Fluvoxamine Maleate

Product NDC
71335-1974
11-digit product format
713351974
Labeler code
71335
Product ID
71335-1974_edc23496-df64-4284-9f04-f2b35bf19c00
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluvoxamine Maleate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fluvoxamine Maleate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUVOXAMINE MALEATE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5LGN83G74V
Rxcui903891

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-1974-12024-05-17C16284748780-11030e365-2f5c-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use FLUVOXAMINE MALEATE TABLETS safely and effectively. See full prescribing information for FLUVOXAMINE MALEATE TABLETS. FLUVOXAMINE MALEATE tablets, for oral use Initial U.S. Approval: 1994
71335-1974-22024-05-17C16284748780-11030e365-2f5c-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use FLUVOXAMINE MALEATE TABLETS safely and effectively. See full prescribing information for FLUVOXAMINE MALEATE TABLETS. FLUVOXAMINE MALEATE tablets, for oral use Initial U.S. Approval: 1994
71335-1974-12024-01-30C16284748780-11030e365-2f5c-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use FLUVOXAMINE MALEATE TABLETS safely and effectively. See full prescribing information for FLUVOXAMINE MALEATE TABLETS. FLUVOXAMINE MALEATE tablets, for oral use Initial U.S. Approval: 1994
71335-1974-22024-01-30C16284748780-11030e365-2f5c-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use FLUVOXAMINE MALEATE TABLETS safely and effectively. See full prescribing information for FLUVOXAMINE MALEATE TABLETS. FLUVOXAMINE MALEATE tablets, for oral use Initial U.S. Approval: 1994

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1974-1Fluvoxamine Maleate60 in 1 BOTTLETABLET60103
71335-1974-2Fluvoxamine Maleate30 in 1 BOTTLETABLET30103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1974FLUVOXAMINE MALEATE TABLET [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 2 package rows20240518_47daea9e-545d-4a67-b2b2-d12c3c98734b.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1974-17133519740160 TABLET in 1 BOTTLE (71335-1974-1) 60 tablet2022-02-140000-00-00NoNoCurrent
71335-1974-27133519740230 TABLET in 1 BOTTLE (71335-1974-2) 30 tablet2021-10-140000-00-00NoNoCurrent