NDC 0002-3231

Symbyax

Olanzapine And Fluoxetine Hydrochloride

Symbyax is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Eli Lilly And Company. The primary component is Olanzapine; Fluoxetine Hydrochloride.

Product ID0002-3231_087c16dc-e0c2-4c5b-8cc8-f703a992f5d9
NDC0002-3231
Product TypeHuman Prescription Drug
Proprietary NameSymbyax
Generic NameOlanzapine And Fluoxetine Hydrochloride
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2003-12-24
Marketing CategoryNDA / NDA
Application NumberNDA021520
Labeler NameEli Lilly and Company
Substance NameOLANZAPINE; FLUOXETINE HYDROCHLORIDE
Active Ingredient Strength6 mg/1; mg/1
Pharm ClassesAtypical Antipsychotic [EPC],Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0002-3231-30

30 CAPSULE in 1 BOTTLE (0002-3231-30)
Marketing Start Date2004-01-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0002-3231-30 [00002323130]

Symbyax CAPSULE
Marketing CategoryNDA
Application NumberNDA021520
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2004-01-19

NDC 0002-3231-01 [00002323101]

Symbyax CAPSULE
Marketing CategoryNDA
Application NumberNDA021520
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2003-12-24
Marketing End Date2013-08-09

NDC 0002-3231-07 [00002323107]

Symbyax CAPSULE
Marketing CategoryNDA
Application NumberNDA021520
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-06-29
Marketing End Date2013-08-09

NDC 0002-3231-04 [00002323104]

Symbyax CAPSULE
Marketing CategoryNDA
Application NumberNDA021520
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2003-12-24
Marketing End Date2010-10-22

NDC 0002-3231-33 [00002323133]

Symbyax CAPSULE
Marketing CategoryNDA
Application NumberNDA021520
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2003-12-24
Marketing End Date2013-08-09

NDC 0002-3231-02 [00002323102]

Symbyax CAPSULE
Marketing CategoryNDA
Application NumberNDA021520
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2003-12-24
Marketing End Date2010-10-22

Drug Details

Active Ingredients

IngredientStrength
OLANZAPINE6 mg/1

OpenFDA Data

SPL SET ID:6b28c424-0b7e-4b75-b090-f116b113554e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 725080
  • 725064
  • 725072
  • 725076
  • 403969
  • 721787
  • 725068
  • 403972
  • 403971
  • 403970
  • UPC Code
  • 0300023233301
  • 0300023230300
  • 0300023231307
  • 0300023232304
  • 0300023234308
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Symbyax" or generic name "Olanzapine And Fluoxetine Hydrochloride"

    NDCBrand NameGeneric Name
    0002-3230SymbyaxOlanzapine and Fluoxetine hydrochloride
    0002-3231SymbyaxOlanzapine and Fluoxetine hydrochloride
    0002-3232SymbyaxOlanzapine and Fluoxetine hydrochloride
    0002-3233SymbyaxOlanzapine and Fluoxetine hydrochloride
    0002-3234SymbyaxOlanzapine and Fluoxetine hydrochloride

    Trademark Results [Symbyax]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    SYMBYAX
    SYMBYAX
    76230425 2926531 Live/Registered
    Eli Lilly and Company
    2001-03-26

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