NDC 67544-848

Fluoxetine Hydrochloride

Fluoxetine Hydrochloride

Fluoxetine Hydrochloride is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, Llc. The primary component is Fluoxetine Hydrochloride.

Product ID67544-848_b6d3beec-9ded-46ae-9122-462504bf2741
NDC67544-848
Product TypeHuman Prescription Drug
Proprietary NameFluoxetine Hydrochloride
Generic NameFluoxetine Hydrochloride
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2002-01-29
Marketing CategoryANDA / ANDA
Application NumberANDA075049
Labeler NameAphena Pharma Solutions - Tennessee, LLC
Substance NameFLUOXETINE HYDROCHLORIDE
Active Ingredient Strength20 mg/1
Pharm ClassesSerotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 67544-848-30

30 CAPSULE in 1 BOTTLE, PLASTIC (67544-848-30)
Marketing Start Date2002-01-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67544-848-45 [67544084845]

Fluoxetine Hydrochloride CAPSULE
Marketing CategoryANDA
Application NumberANDA075049
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2002-01-29
Inactivation Date2020-01-31

NDC 67544-848-60 [67544084860]

Fluoxetine Hydrochloride CAPSULE
Marketing CategoryANDA
Application NumberANDA075049
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2002-01-29
Inactivation Date2020-01-31

NDC 67544-848-53 [67544084853]

Fluoxetine Hydrochloride CAPSULE
Marketing CategoryANDA
Application NumberANDA075049
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2002-01-29
Inactivation Date2020-01-31

NDC 67544-848-70 [67544084870]

Fluoxetine Hydrochloride CAPSULE
Marketing CategoryANDA
Application NumberANDA075049
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2002-01-29
Inactivation Date2020-01-31

NDC 67544-848-30 [67544084830]

Fluoxetine Hydrochloride CAPSULE
Marketing CategoryANDA
Application NumberANDA075049
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2002-01-29
Inactivation Date2020-01-31

NDC 67544-848-80 [67544084880]

Fluoxetine Hydrochloride CAPSULE
Marketing CategoryANDA
Application NumberANDA075049
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2002-01-29
Inactivation Date2020-01-31

NDC 67544-848-92 [67544084892]

Fluoxetine Hydrochloride CAPSULE
Marketing CategoryANDA
Application NumberANDA075049
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2002-01-29
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
FLUOXETINE HYDROCHLORIDE20 mg/1

OpenFDA Data

SPL SET ID:2017acf4-ce16-4014-8105-31950f696e44
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310385

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0378-5410Fluoxetine Hydrochloridefluoxetine hydrochloride
    0378-5420Fluoxetine Hydrochloridefluoxetine hydrochloride
    0615-1387Fluoxetine HydrochlorideFluoxetine Hydrochloride
    0615-5501Fluoxetine HydrochlorideFluoxetine
    0615-5502Fluoxetine HydrochlorideFluoxetine
    0781-2822Fluoxetine HydrochlorideFluoxetine Hydrochloride
    0781-2823Fluoxetine HydrochlorideFluoxetine Hydrochloride
    0781-2824Fluoxetine HydrochlorideFluoxetine Hydrochloride
    0832-0402Fluoxetine HydrochlorideFluoxetine Hydrochloride
    70518-0170Fluoxetine HydrochlorideFluoxetine Hydrochloride
    70518-0642Fluoxetine HydrochlorideFluoxetine Hydrochloride
    70518-0769Fluoxetine HydrochlorideFluoxetine Hydrochloride
    70934-141Fluoxetine HydrochlorideFluoxetine Hydrochloride
    0832-0403Fluoxetine HydrochlorideFluoxetine Hydrochloride
    21695-321Fluoxetine HydrochlorideFluoxetine Hydrochloride
    21695-320Fluoxetine HydrochlorideFluoxetine Hydrochloride
    43353-637Fluoxetine HydrochlorideFluoxetine Hydrochloride
    43598-632Fluoxetine hydrochlorideFluoxetine hydrochloride
    46708-242Fluoxetine HydrochlorideFluoxetine Hydrochloride
    46708-243Fluoxetine HydrochlorideFluoxetine Hydrochloride
    47781-600Fluoxetine HydrochlorideFluoxetine Hydrochloride
    49884-336fluoxetine hydrochloridefluoxetine hydrochloride
    49884-335fluoxetine hydrochloridefluoxetine hydrochloride
    51655-100fluoxetine hydrochloridefluoxetine hydrochloride
    51655-101fluoxetine hydrochloridefluoxetine hydrochloride
    51672-5306FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDE
    53808-0986Fluoxetine HydrochlorideFluoxetine Hydrochloride
    53808-0988Fluoxetine HydrochlorideFluoxetine Hydrochloride
    53808-0366Fluoxetine HydrochlorideFluoxetine Hydrochloride
    55111-284Fluoxetine hydrochlorideFluoxetine hydrochloride
    60760-282Fluoxetine HydrochlorideFluoxetine Hydrochloride
    61919-099FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDE
    63629-6855Fluoxetine HydrochlorideFluoxetine Hydrochloride
    67046-211Fluoxetine HydrochlorideFluoxetine Hydrochloride
    67544-848Fluoxetine HydrochlorideFluoxetine Hydrochloride
    68180-997Fluoxetine HydrochlorideFluoxetine Hydrochloride
    68180-998Fluoxetine HydrochlorideFluoxetine Hydrochloride
    68180-999Fluoxetine HydrochlorideFluoxetine Hydrochloride
    16714-114Fluoxetine hydrochlorideFluoxetine hydrochloride
    0121-0721FluoxetineFLUOXETINE HYDROCHLORIDE
    0121-4721FluoxetineFLUOXETINE HYDROCHLORIDE
    0615-1357fluoxetinefluoxetine hydrochloride
    0615-1384FluoxetineFluoxetine Hydrochloride
    0615-8183FluoxetineFluoxetine Hydrochloride
    0002-3004ProzacFluoxetine hydrochloride
    0777-3104ProzacFluoxetine hydrochloride
    0777-3105ProzacFluoxetine hydrochloride
    0777-3107ProzacFluoxetine hydrochloride
    0430-0210SARAFEMfluoxetine hydrochloride
    0430-0215SARAFEMfluoxetine hydrochloride
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