NDC 0430-0210

SARAFEM

Fluoxetine Hydrochloride

SARAFEM is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Allergan, Inc.. The primary component is Fluoxetine Hydrochloride.

Product ID0430-0210_01dbb115-7a56-42c2-b6c9-d9ded44fab80
NDC0430-0210
Product TypeHuman Prescription Drug
Proprietary NameSARAFEM
Generic NameFluoxetine Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2008-06-24
Marketing CategoryNDA / NDA
Application NumberNDA021860
Labeler NameAllergan, Inc.
Substance NameFLUOXETINE HYDROCHLORIDE
Active Ingredient Strength10 mg/1
Pharm ClassesSerotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0430-0210-14

4 BLISTER PACK in 1 CARTON (0430-0210-14) > 7 TABLET in 1 BLISTER PACK
Marketing Start Date2008-06-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0430-0210-14 [00430021014]

SARAFEM TABLET
Marketing CategoryNDA
Application NumberNDA021860
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-06-24

NDC 0430-0210-95 [00430021095]

SARAFEM TABLET
Marketing CategoryNDA
Application NumberNDA021860
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-06-24
Marketing End Date2009-12-15

Drug Details

Active Ingredients

IngredientStrength
FLUOXETINE HYDROCHLORIDE10 mg/1

OpenFDA Data

SPL SET ID:e542de29-b400-4b2e-9d5e-0f7c53091f8c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 803295
  • 248642
  • 313990
  • 647556
  • 647555
  • 803293

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0430-0210SARAFEMfluoxetine hydrochloride
    0430-0215SARAFEMfluoxetine hydrochloride
    0430-0220SARAFEMfluoxetine hydrochloride
    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
    0002-3004ProzacFluoxetine hydrochloride
    0777-3104ProzacFluoxetine hydrochloride
    0777-3105ProzacFluoxetine hydrochloride
    0777-3107ProzacFluoxetine hydrochloride

    Trademark Results [SARAFEM]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    SARAFEM
    SARAFEM
    75547314 2470102 Live/Registered
    ALLERGAN PHARMACEUTICALS INTERNATIONAL LIMITED
    1998-09-03
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