Fluvoxamine maleate

Product NDC
0832-1672
11-digit product format
008321672
Labeler code
0832
Product ID
0832-1672_45afd276-9f2a-23cd-e063-6294a90a0991
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluvoxamine maleate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Upsher-Smith Laboratories, LLC
Application
ANDA075888
Marketing category
ANDA
Marketing start
2000-11-29
Marketing end
2026-06-30
Substance
FLUVOXAMINE MALEATE
Active strength
100 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fluvoxamine maleate

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUVOXAMINE MALEATE100 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
0832-1672-11Fluvoxamine maleate100 in 1 BOTTLETABLET, FILM COATED10011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0832-1672FLUVOXAMINE MALEATE TABLET, FILM COATED [UPSHER-SMITH LABORATORIES, LLC]9Current NDC, Legacy NDC, 1 package rows20231004_52b29024-b639-4c88-ac6c-0c64dbd204f4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
903884fluvoxaMINE maleate 100 MG Oral TabletPSN52b29024-b639-4c88-ac6c-0c64dbd204f411
903887fluvoxaMINE maleate 25 MG Oral TabletPSN52b29024-b639-4c88-ac6c-0c64dbd204f411
903891fluvoxaMINE maleate 50 MG Oral TabletPSN52b29024-b639-4c88-ac6c-0c64dbd204f411
903884fluvoxamine maleate 100 MG Oral TabletSCD52b29024-b639-4c88-ac6c-0c64dbd204f411
903887fluvoxamine maleate 25 MG Oral TabletSCD52b29024-b639-4c88-ac6c-0c64dbd204f411
903891fluvoxamine maleate 50 MG Oral TabletSCD52b29024-b639-4c88-ac6c-0c64dbd204f411

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0832-1672-1100832167211100 TABLET, FILM COATED in 1 BOTTLE (0832-1672-11) 2020-01-082026-06-30NoNoCurrent