NDC 0185-0027

fluvoxamine maleate

Fluvoxamine Maleate

fluvoxamine maleate is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Eon Labs, Inc.. The primary component is Fluvoxamine Maleate.

Product ID0185-0027_5e75a2ef-3f32-4d97-8660-d20c6b0356cf
NDC0185-0027
Product TypeHuman Prescription Drug
Proprietary Namefluvoxamine maleate
Generic NameFluvoxamine Maleate
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2000-11-29
Marketing CategoryANDA / ANDA
Application NumberANDA075888
Labeler NameEon Labs, Inc.
Substance NameFLUVOXAMINE MALEATE
Active Ingredient Strength50 mg/1
Pharm ClassesSerotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0185-0027-01

100 TABLET, FILM COATED in 1 BOTTLE (0185-0027-01)
Marketing Start Date2000-11-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0185-0027-01 [00185002701]

fluvoxamine maleate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA075888
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2000-11-29
Marketing End Date2018-09-30

NDC 0185-0027-05 [00185002705]

fluvoxamine maleate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA075888
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2000-11-29
Marketing End Date2018-09-30

NDC 0185-0027-30 [00185002730]

fluvoxamine maleate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA075888
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2000-11-29
Marketing End Date2014-12-02

Drug Details

Active Ingredients

IngredientStrength
FLUVOXAMINE MALEATE50 mg/1

OpenFDA Data

SPL SET ID:6ffd38bc-0fa1-4ed5-8391-98487b7823d4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 903884
  • 903891
  • 903887

    • Pharmacological Class

    • Serotonin Reuptake Inhibitor [EPC]
    • Serotonin Uptake Inhibitors [MoA]

    NDC Crossover Matching brand name "fluvoxamine maleate" or generic name "Fluvoxamine Maleate"

    NDCBrand NameGeneric Name
    0185-0017fluvoxamine maleatefluvoxamine maleate
    0185-0027fluvoxamine maleatefluvoxamine maleate
    0185-0157fluvoxamine maleatefluvoxamine maleate
    0228-2848Fluvoxamine MaleateFluvoxamine Maleate
    0228-2849Fluvoxamine MaleateFluvoxamine Maleate
    0378-0407Fluvoxamine Maleatefluvoxamine maleate
    0378-0412Fluvoxamine Maleatefluvoxamine maleate
    0378-0414Fluvoxamine Maleatefluvoxamine maleate
    0615-7569Fluvoxamine MaleateFluvoxamine Maleate
    0832-1670Fluvoxamine maleateFluvoxamine maleate
    0832-1671Fluvoxamine maleateFluvoxamine maleate
    0832-1672Fluvoxamine maleateFluvoxamine maleate
    10370-175Fluvoxamine MaleateFluvoxamine Maleate
    10370-176Fluvoxamine MaleateFluvoxamine Maleate
    13668-290Fluvoxamine MaleateFluvoxamine Maleate
    13668-291Fluvoxamine MaleateFluvoxamine Maleate
    33261-683fluvoxamine maleateFluvoxamine maleate
    49349-991FLuvoxamine MaleateFLUVOXAMINE MALEATE
    50090-5988fluvoxamine maleateFluvoxamine maleate
    50268-340Fluvoxamine MaleateFluvoxamine Maleate
    50268-341Fluvoxamine MaleateFluvoxamine Maleate
    50268-342Fluvoxamine MaleateFluvoxamine Maleate
    51079-992Fluvoxamine Maleatefluvoxamine maleate
    51079-993Fluvoxamine Maleatefluvoxamine maleate
    57664-357FLUVOXAMINE MALEATEfluvoxamine maleate
    57664-361FLUVOXAMINE MALEATEfluvoxamine maleate
    57664-362FLUVOXAMINE MALEATEfluvoxamine maleate
    60505-0164Fluvoxamine MaleateFluvoxamine Maleate
    68151-0637fluvoxamine maleatefluvoxamine maleate
    68788-7219fluvoxamine maleatefluvoxamine maleate
    70518-1057fluvoxamine maleatefluvoxamine maleate
    70518-1643fluvoxamine maleatefluvoxamine maleate
    70518-1789fluvoxamine maleatefluvoxamine maleate
    71335-0264fluvoxamine maleatefluvoxamine maleate
    60505-0166Fluvoxamine MaleateFluvoxamine Maleate
    60505-0165Fluvoxamine MaleateFluvoxamine Maleate
    62559-158fluvoxamine maleatefluvoxamine maleate
    62559-159fluvoxamine maleatefluvoxamine maleate
    62559-160fluvoxamine maleatefluvoxamine maleate
    63629-4676fluvoxamine maleatefluvoxamine maleate
    63629-8018fluvoxamine maleatefluvoxamine maleate
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