NDC 21695-321

Fluoxetine Hydrochloride

Fluoxetine Hydrochloride

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

Product ID21695-321_10a49211-025b-4d63-b60c-fadfd9b731c0
NDC21695-321
Product TypeHuman Prescription Drug
Proprietary NameFluoxetine Hydrochloride
Generic NameFluoxetine Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2010-01-13
Marketing CategoryANDA / ANDA
Application NumberANDA075755
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 21695-321-60

60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (21695-321-60)
Marketing Start Date2010-01-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 21695-321-90 [21695032190]

Fluoxetine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA075755
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-01-13
Inactivation Date2019-09-24

NDC 21695-321-00 [21695032100]

Fluoxetine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA075755
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-01-13
Inactivation Date2019-09-24

NDC 21695-321-30 [21695032130]

Fluoxetine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA075755
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-01-13
Inactivation Date2019-09-24

NDC 21695-321-60 [21695032160]

Fluoxetine Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA075755
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-01-13
Inactivation Date2019-09-24

Drug Details

Active Ingredients

IngredientStrength
FLUOXETINE HYDROCHLORIDE20 mg/1

OpenFDA Data

SPL SET ID:10a49211-025b-4d63-b60c-fadfd9b731c0
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 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.