FDA.reportPublic FDA data

Fluvoxamine Maleate

Product NDC
71335-2008
11-digit product format
713352008
Labeler code
71335
Product ID
71335-2008_8804bbed-1668-455c-bb8f-7d3325f2cf9c
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
100 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 MALEATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5LGN83G74V
Rxcui903884

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
71335-2008-1Fluvoxamine Maleate90 in 1 BOTTLETABLET90104
71335-2008-2Fluvoxamine Maleate30 in 1 BOTTLETABLET30104
71335-2008-3Fluvoxamine Maleate18 in 1 BOTTLETABLET18104
71335-2008-4Fluvoxamine Maleate28 in 1 BOTTLETABLET28104
71335-2008-5Fluvoxamine Maleate100 in 1 BOTTLETABLET100104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2008FLUVOXAMINE MALEATE TABLET [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 5 package rows20240502_4239fc32-e5cb-4393-b90c-742db42b5d07.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
903884fluvoxaMINE maleate 100 MG Oral TabletPSN4239fc32-e5cb-4393-b90c-742db42b5d07104
903884fluvoxamine maleate 100 MG Oral TabletSCD4239fc32-e5cb-4393-b90c-742db42b5d07104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-2008-17133520080190 TABLET in 1 BOTTLE (71335-2008-1) 90 tablet2022-01-170000-00-00NoNoCurrent
71335-2008-27133520080230 TABLET in 1 BOTTLE (71335-2008-2) 30 tablet2022-02-170000-00-00NoNoCurrent
71335-2008-37133520080318 TABLET in 1 BOTTLE (71335-2008-3) 18 tablet2024-04-030000-00-00NoNoCurrent
71335-2008-47133520080428 TABLET in 1 BOTTLE (71335-2008-4) 28 tablet2024-04-030000-00-00NoNoCurrent
71335-2008-571335200805100 TABLET in 1 BOTTLE (71335-2008-5) 100 tablet2023-09-13NoNoCurrent