NDC 45865-451

Fluoxetine

Fluoxetine

Fluoxetine is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Medsource Pharmaceuticals. The primary component is Fluoxetine Hydrochloride.

Product ID45865-451_f25a460e-1569-4af3-ac4a-b99f44c51313
NDC45865-451
Product TypeHuman Prescription Drug
Proprietary NameFluoxetine
Generic NameFluoxetine
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2009-06-09
Marketing CategoryANDA / ANDA
Application NumberANDA075465
Labeler NameMedsource Pharmaceuticals
Substance NameFLUOXETINE HYDROCHLORIDE
Active Ingredient Strength20 mg/1
Pharm ClassesSerotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 45865-451-60

60 CAPSULE in 1 BOTTLE (45865-451-60)
Marketing Start Date2009-06-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 45865-451-30 [45865045130]

Fluoxetine CAPSULE
Marketing CategoryANDA
Application NumberANDA075465
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-06-09
Inactivation Date2019-11-13

NDC 45865-451-90 [45865045190]

Fluoxetine CAPSULE
Marketing CategoryANDA
Application NumberANDA075465
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-06-09
Inactivation Date2019-11-13

NDC 45865-451-60 [45865045160]

Fluoxetine CAPSULE
Marketing CategoryANDA
Application NumberANDA075465
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-06-09
Inactivation Date2019-11-13

Drug Details

Active Ingredients

IngredientStrength
FLUOXETINE HYDROCHLORIDE20 mg/1

OpenFDA Data

SPL SET ID:0a2787f9-0166-4fa7-9f02-7d355609dabf
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310385
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Fluoxetine" or generic name "Fluoxetine"

    NDCBrand NameGeneric Name
    0093-0807FluoxetineFluoxetine
    0093-5262FluoxetineFluoxetine
    0093-7188FluoxetineFluoxetine
    0093-7198FluoxetineFluoxetine
    0121-0721FluoxetineFLUOXETINE HYDROCHLORIDE
    0121-4721FluoxetineFLUOXETINE HYDROCHLORIDE
    0378-0734Fluoxetinefluoxetine
    0378-0735Fluoxetinefluoxetine
    0615-1357fluoxetinefluoxetine hydrochloride
    0615-1384FluoxetineFluoxetine Hydrochloride
    68001-129FluoxetineFluoxetine
    68071-3130FluoxetineFluoxetine
    68071-3133FluoxetineFluoxetine
    68071-3318FluoxetineFluoxetine
    68071-3367FluoxetineFluoxetine
    68071-3110FLUOXETINEFLUOXETINE
    68071-3284FluoxetineFluoxetine
    68071-4033FluoxetineFluoxetine
    68071-4314FluoxetineFluoxetine
    68071-4043FluoxetineFluoxetine
    68071-4606FluoxetineFluoxetine
    68071-4653FluoxetineFluoxetine
    68071-4671FluoxetineFluoxetine
    68071-4542FluoxetineFluoxetine
    68084-101FluoxetineFluoxetine
    68084-605FluoxetineFluoxetine
    68645-130FluoxetineFluoxetine
    68645-131FluoxetineFluoxetine
    68788-6790FLUOXETINEFLUOXETINE
    68788-9223FluoxetineFluoxetine
    68788-6794FLUOXETINEFLUOXETINE
    68788-7356FluoxetineFluoxetine
    68788-7409FluoxetineFluoxetine
    68788-9222FluoxetineFluoxetine
    70518-0262FLUOXETINEFLUOXETINE
    70518-0032FLUOXETINEFLUOXETINE
    70518-0369FluoxetineFluoxetine
    70518-0417FluoxetineFluoxetine
    70518-0997FluoxetineFluoxetine
    70518-1174FluoxetineFluoxetine
    70518-0971FluoxetineFluoxetine
    70518-1432FluoxetineFluoxetine
    70518-1321FluoxetineFluoxetine
    70518-1775FluoxetineFluoxetine
    70518-1359FluoxetineFluoxetine
    70518-1619FluoxetineFluoxetine
    70518-1757FluoxetineFluoxetine
    70518-1987FluoxetineFluoxetine
    70934-077FluoxetineFluoxetine
    71205-178FluoxetineFluoxetine

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