NDC 0615-5501

Fluoxetine Hydrochloride

Fluoxetine

Fluoxetine Hydrochloride is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Ncs Healthcare Of Ky, Inc Dba Vangard Labs. The primary component is Fluoxetine Hydrochloride.

Product ID0615-5501_fb0613bf-4712-4563-aba8-a741a0e3f732
NDC0615-5501
Product TypeHuman Prescription Drug
Proprietary NameFluoxetine Hydrochloride
Generic NameFluoxetine
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2010-01-13
Marketing CategoryANDA / ANDA
Application NumberANDA075755
Labeler NameNCS HealthCare of KY, Inc dba Vangard Labs
Substance NameFLUOXETINE HYDROCHLORIDE
Active Ingredient Strength10 mg/1
Pharm ClassesSerotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 0615-5501-31

31 TABLET, FILM COATED in 1 BLISTER PACK (0615-5501-31)
Marketing Start Date2010-01-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0615-5501-31 [00615550131]

Fluoxetine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA075755
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-01-13
Inactivation Date2020-01-31

NDC 0615-5501-39 [00615550139]

Fluoxetine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA075755
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-01-13
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
FLUOXETINE HYDROCHLORIDE10 mg/1

OpenFDA Data

SPL SET ID:9b73e222-bb58-49b4-a27a-484738d42ba6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 248642
  • 313990
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0378-5410Fluoxetine Hydrochloridefluoxetine hydrochloride
    70518-0170Fluoxetine HydrochlorideFluoxetine Hydrochloride
    70518-0642Fluoxetine HydrochlorideFluoxetine Hydrochloride
    70518-0769Fluoxetine HydrochlorideFluoxetine Hydrochloride
    70934-141Fluoxetine HydrochlorideFluoxetine Hydrochloride
    0615-1387Fluoxetine HydrochlorideFluoxetine Hydrochloride
    0615-5502Fluoxetine HydrochlorideFluoxetine Hydrochloride
    0615-5501Fluoxetine HydrochlorideFluoxetine Hydrochloride
    0781-2824Fluoxetine HydrochlorideFluoxetine Hydrochloride
    0781-2822Fluoxetine HydrochlorideFluoxetine Hydrochloride
    0781-2823Fluoxetine HydrochlorideFluoxetine Hydrochloride
    0832-0402Fluoxetine 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
    0378-5420Fluoxetine 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
    0093-0807FluoxetineFluoxetine
    0093-5262FluoxetineFluoxetine
    0093-7188FluoxetineFluoxetine
    0093-7198FluoxetineFluoxetine
    0121-0721FluoxetineFLUOXETINE HYDROCHLORIDE
    0121-4721FluoxetineFLUOXETINE HYDROCHLORIDE
    0378-0734Fluoxetinefluoxetine
    0378-0735Fluoxetinefluoxetine
    0002-3004ProzacFluoxetine hydrochloride

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