NDC 60505-0165

Fluvoxamine Maleate

Fluvoxamine Maleate

Fluvoxamine Maleate is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Apotex Corp. The primary component is Fluvoxamine Maleate.

Product ID60505-0165_2db9f067-c38f-dd78-efc4-6f34d492996c
NDC60505-0165
Product TypeHuman Prescription Drug
Proprietary NameFluvoxamine Maleate
Generic NameFluvoxamine Maleate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2001-07-10
Marketing CategoryANDA / ANDA
Application NumberANDA075902
Labeler NameApotex Corp
Substance NameFLUVOXAMINE MALEATE
Active Ingredient Strength50 mg/1
Pharm ClassesSerotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 60505-0165-1

100 TABLET in 1 BOTTLE (60505-0165-1)
Marketing Start Date2001-07-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 60505-0165-2 [60505016502]

Fluvoxamine Maleate TABLET
Marketing CategoryANDA
Application NumberANDA075902
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2001-07-10

NDC 60505-0165-1 [60505016501]

Fluvoxamine Maleate TABLET
Marketing CategoryANDA
Application NumberANDA075902
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2001-07-10

Drug Details

Active Ingredients

IngredientStrength
FLUVOXAMINE MALEATE50 mg/1

OpenFDA Data

SPL SET ID:6eeb14df-6fcf-a737-5359-5744eb4accea
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 903884
  • 903891
  • 903887
  • UPC Code
  • 0360505016419
  • 0360505016518
  • 0360505016617
  • Pharmacological Class

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

    Medicade Reported Pricing

    60505016501 FLUVOXAMINE MALEATE 50 MG TAB

    Pricing Unit: EA | Drug Type:

    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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.