NDC 21695-053

Fluoxetine

Fluoxetine Hydrochloride

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

Product ID21695-053_a1575590-4bdd-4f66-91fb-337e5f681747
NDC21695-053
Product TypeHuman Prescription Drug
Proprietary NameFluoxetine
Generic NameFluoxetine Hydrochloride
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2008-01-31
Marketing CategoryANDA / ANDA
Application NumberANDA078619
Labeler NameRebel Distributors Corp
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 21695-053-90

90 CAPSULE in 1 BOTTLE (21695-053-90)
Marketing Start Date2008-01-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 21695-053-30 [21695005330]

Fluoxetine CAPSULE
Marketing CategoryANDA
Application NumberANDA078619
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-01-31
Inactivation Date2019-09-24

NDC 21695-053-90 [21695005390]

Fluoxetine CAPSULE
Marketing CategoryANDA
Application NumberANDA078619
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-01-31
Inactivation Date2019-09-24

NDC 21695-053-60 [21695005360]

Fluoxetine CAPSULE
Marketing CategoryANDA
Application NumberANDA078619
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-01-31
Inactivation Date2019-09-24

Drug Details

Active Ingredients

IngredientStrength
FLUOXETINE HYDROCHLORIDE20 mg/1

OpenFDA Data

SPL SET ID:a1575590-4bdd-4f66-91fb-337e5f681747
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310385
  • 310384

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0093-0807FluoxetineFluoxetine
    0093-5262FluoxetineFluoxetine
    0093-7188FluoxetineFluoxetine
    0093-7198FluoxetineFluoxetine
    0121-0721FluoxetineFLUOXETINE HYDROCHLORIDE
    0121-4721FluoxetineFLUOXETINE HYDROCHLORIDE
    0378-0734Fluoxetinefluoxetine
    0378-0735Fluoxetinefluoxetine
    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
    0615-1384FluoxetineFluoxetine
    71205-188FluoxetineFluoxetine
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.