NDC 0777-3105

Prozac

Fluoxetine Hydrochloride

Prozac is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Dista Products Company. The primary component is Fluoxetine Hydrochloride.

Product ID0777-3105_0625828f-fce4-4d6c-bf6e-4a4444e0d357
NDC0777-3105
Product TypeHuman Prescription Drug
Proprietary NameProzac
Generic NameFluoxetine Hydrochloride
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date1988-02-01
Marketing CategoryNDA / NDA
Application NumberNDA018936
Labeler NameDista Products Company
Substance NameFLUOXETINE HYDROCHLORIDE
Active Ingredient Strength20 mg/1
Pharm ClassesSerotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0777-3105-02

100 CAPSULE in 1 BOTTLE (0777-3105-02)
Marketing Start Date1988-02-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0777-3105-30 [00777310530]

Prozac CAPSULE
Marketing CategoryNDA
Application NumberNDA018936
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1988-02-01

NDC 0777-3105-07 [00777310507]

Prozac CAPSULE
Marketing CategoryNDA
Application NumberNDA018936
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1988-02-01
Marketing End Date2021-09-30

NDC 0777-3105-02 [00777310502]

Prozac CAPSULE
Marketing CategoryNDA
Application NumberNDA018936
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1988-02-01

Drug Details

Active Ingredients

IngredientStrength
FLUOXETINE HYDROCHLORIDE20 mg/1

OpenFDA Data

SPL SET ID:c88f33ed-6dfb-4c5e-bc01-d8e36dd97299
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 261287
  • 205535
  • 313989
  • 104849
  • 310385
  • 310384
    • UPC Code
  • 0307773104028
  • 0307773107302
  • 0307773105025

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0002-3004ProzacFluoxetine hydrochloride
    0777-3104ProzacFluoxetine hydrochloride
    0777-3105ProzacFluoxetine hydrochloride
    0777-3107ProzacFluoxetine hydrochloride
    70518-2101ProzacProzac
    0121-0721FluoxetineFLUOXETINE HYDROCHLORIDE
    0121-4721FluoxetineFLUOXETINE HYDROCHLORIDE
    0615-1357fluoxetinefluoxetine hydrochloride
    0615-1384FluoxetineFluoxetine Hydrochloride
    0615-8183FluoxetineFluoxetine Hydrochloride
    0378-5410Fluoxetine Hydrochloridefluoxetine hydrochloride
    0378-5420Fluoxetine Hydrochloridefluoxetine hydrochloride
    0615-1387Fluoxetine HydrochlorideFluoxetine Hydrochloride
    0781-2822Fluoxetine HydrochlorideFluoxetine Hydrochloride
    0781-2823Fluoxetine HydrochlorideFluoxetine Hydrochloride
    0781-2824Fluoxetine HydrochlorideFluoxetine Hydrochloride
    0832-0402Fluoxetine HydrochlorideFluoxetine Hydrochloride
    0430-0210SARAFEMfluoxetine hydrochloride
    0430-0215SARAFEMfluoxetine hydrochloride
    0430-0220SARAFEMfluoxetine hydrochloride

    Trademark Results [Prozac]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    PROZAC
    PROZAC
    75624452 2298322 Live/Registered
    ELI LILLY AND COMPANY
    1999-01-20
    PROZAC
    PROZAC
    73520776 1357582 Live/Registered
    ELI LILLY AND COMPANY
    1985-02-04
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.