NDC 0781-2823

Fluoxetine Hydrochloride

Fluoxetine Hydrochloride

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

Product ID0781-2823_12d620e6-f51e-4ad1-86d5-3fff6401a673
NDC0781-2823
Product TypeHuman Prescription Drug
Proprietary NameFluoxetine Hydrochloride
Generic NameFluoxetine Hydrochloride
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2001-08-02
Marketing End Date2022-10-31
Marketing CategoryANDA / ANDA
Application NumberANDA075049
Labeler NameSandoz Inc
Substance NameFLUOXETINE HYDROCHLORIDE
Active Ingredient Strength10 mg/1
Pharm ClassesSerotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC Exclude FlagN

Packaging

NDC 0781-2823-01

100 CAPSULE in 1 BOTTLE (0781-2823-01)
Marketing Start Date2001-08-02
Marketing End Date2022-08-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0781-2823-01 [00781282301]

Fluoxetine Hydrochloride CAPSULE
Marketing CategoryANDA
Application NumberANDA075049
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2001-08-02
Marketing End Date2022-08-31

NDC 0781-2823-31 [00781282331]

Fluoxetine Hydrochloride CAPSULE
Marketing CategoryANDA
Application NumberANDA075049
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2001-08-02
Marketing End Date2019-02-19

NDC 0781-2823-13 [00781282313]

Fluoxetine Hydrochloride CAPSULE
Marketing CategoryANDA
Application NumberANDA075049
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2001-08-02
Marketing End Date2014-12-11

NDC 0781-2823-10 [00781282310]

Fluoxetine Hydrochloride CAPSULE
Marketing CategoryANDA
Application NumberANDA075049
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2001-08-02
Marketing End Date2022-09-30

Drug Details

Active Ingredients

IngredientStrength
FLUOXETINE HYDROCHLORIDE10 mg/1

OpenFDA Data

SPL SET ID:db1c840d-ab22-4a4c-9ced-ae82c869dd9b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310385
  • 310384
  • 313989

    • 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
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