NDC 35356-843

Cymbalta

Duloxetine Hydrochloride

Cymbalta is a Oral Capsule, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Lake Erie Medical Dba Quality Care Products Llc. The primary component is Duloxetine Hydrochloride.

Product ID35356-843_24049bea-a28e-4015-a4e3-f7a8c84abb42
NDC35356-843
Product TypeHuman Prescription Drug
Proprietary NameCymbalta
Generic NameDuloxetine Hydrochloride
Dosage FormCapsule, Delayed Release
Route of AdministrationORAL
Marketing Start Date2010-01-15
Marketing CategoryNDA / NDA
Application NumberNDA021427
Labeler NameLake Erie Medical DBA Quality Care Products LLC
Substance NameDULOXETINE HYDROCHLORIDE
Active Ingredient Strength60 mg/1
Pharm ClassesNorepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 35356-843-30

30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (35356-843-30)
Marketing Start Date2010-01-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 35356-843-30 [35356084330]

Cymbalta CAPSULE, DELAYED RELEASE
Marketing CategoryNDA
Application NumberNDA021427
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-01-15
Marketing End Date2019-10-11

Drug Details

Active Ingredients

IngredientStrength
DULOXETINE HYDROCHLORIDE60 mg/1

OpenFDA Data

SPL SET ID:bcadfb16-59a9-46d7-b024-8ffff099cf21
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 615186
  • 596934

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Cymbalta" or generic name "Duloxetine Hydrochloride"

    NDCBrand NameGeneric Name
    0002-3235CymbaltaDuloxetine hydrochloride
    0002-3240CymbaltaDuloxetine hydrochloride
    0002-3270CymbaltaDuloxetine hydrochloride
    21695-145CymbaltaDuloxetine hydrochloride
    21695-146CymbaltaDuloxetine hydrochloride
    68151-4734CymbaltaCymbalta
    68151-4679CymbaltaCymbalta
    21695-657CymbaltaCymbalta
    35356-843CymbaltaCymbalta
    43353-303CymbaltaCymbalta
    49999-618CymbaltaCymbalta
    52959-892CymbaltaCymbalta
    55289-028CymbaltaCymbalta
    55289-036CymbaltaCymbalta
    70518-2100CymbaltaCymbalta
    70518-2099CymbaltaCymbalta
    80425-0086CymbaltaCymbalta
    80425-0119CymbaltaCymbalta
    0904-7043DuloxetineDuloxetine Hydrochloride
    0904-7044DuloxetineDuloxetine Hydrochloride
    0904-7045DuloxetineDuloxetine Hydrochloride
    0615-8034Duloxetine HydrochlorideDuloxetine Hydrochloride
    0615-8035Duloxetine HydrochlorideDuloxetine Hydrochloride
    0904-6452Duloxetine HydrochlorideDuloxetine Hydrochloride
    0904-6453Duloxetine HydrochlorideDuloxetine Hydrochloride
    0904-6454Duloxetine HydrochlorideDuloxetine Hydrochloride

    Trademark Results [Cymbalta]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    CYMBALTA
    CYMBALTA
    78859969 3194152 Live/Registered
    Eli Lilly and Company
    2006-04-12
    CYMBALTA
    CYMBALTA
    76535580 not registered Dead/Abandoned
    Eli Lilly and Company
    2003-07-25
    CYMBALTA
    CYMBALTA
    75867543 2802665 Live/Registered
    Eli Lilly and Company
    1999-12-09
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