Fluvoxamine maleate

Product NDC
71335-3006
11-digit product format
713353006
Labeler code
71335
Product ID
71335-3006_7d109f5d-206d-4501-8a53-39798e588c4b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluvoxamine maleate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA217917
Marketing category
ANDA
Marketing start
2025-02-07
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-3006-1Fluvoxamine maleate90 in 1 BOTTLETABLET901
71335-3006-2Fluvoxamine maleate30 in 1 BOTTLETABLET301
71335-3006-3Fluvoxamine maleate18 in 1 BOTTLETABLET181
71335-3006-4Fluvoxamine maleate28 in 1 BOTTLETABLET281
71335-3006-5Fluvoxamine maleate100 in 1 BOTTLETABLET1001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
903884fluvoxaMINE maleate 100 MG Oral TabletPSNc3d59ca9-dd42-4b1c-bd2d-23eb507598b81
903884fluvoxamine maleate 100 MG Oral TabletSCDc3d59ca9-dd42-4b1c-bd2d-23eb507598b81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-3006-17133530060190 TABLET in 1 BOTTLE (71335-3006-1) 90 tablet2026-02-04NoNoHistorical
71335-3006-27133530060230 TABLET in 1 BOTTLE (71335-3006-2) 30 tablet2026-02-04NoNoHistorical
71335-3006-37133530060318 TABLET in 1 BOTTLE (71335-3006-3) 18 tablet2026-02-04NoNoHistorical
71335-3006-47133530060428 TABLET in 1 BOTTLE (71335-3006-4) 28 tablet2026-02-04NoNoHistorical
71335-3006-571335300605100 TABLET in 1 BOTTLE (71335-3006-5) 100 tablet2026-02-04NoNoHistorical