NDC 51672-5306

FLUOXETINE HYDROCHLORIDE

Fluoxetine Hydrochloride

FLUOXETINE HYDROCHLORIDE is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Taro Pharmaceuticals U.s.a., Inc.. The primary component is Fluoxetine Hydrochloride.

Product ID51672-5306_01558766-e3b1-4d19-8247-3e9b589156ed
NDC51672-5306
Product TypeHuman Prescription Drug
Proprietary NameFLUOXETINE HYDROCHLORIDE
Generic NameFluoxetine Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-02-15
Marketing CategoryANDA / ANDA
Application NumberANDA211477
Labeler NameTaro Pharmaceuticals U.S.A., Inc.
Substance NameFLUOXETINE HYDROCHLORIDE
Active Ingredient Strength60 mg/1
Pharm ClassesSerotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 51672-5306-2

500 TABLET, FILM COATED in 1 BOTTLE (51672-5306-2)
Marketing Start Date2019-02-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51672-5306-2 [51672530602]

FLUOXETINE HYDROCHLORIDE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA211477
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-02-15

NDC 51672-5306-6 [51672530606]

FLUOXETINE HYDROCHLORIDE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA211477
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-02-15

Drug Details

Active Ingredients

IngredientStrength
FLUOXETINE HYDROCHLORIDE60 mg/1

OpenFDA Data

SPL SET ID:77b6ae48-8e3a-42e6-9b5a-aeed750861e8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1190110
  • UPC Code
  • 0351672530662
  • Pharmacological Class

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

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