NDC 43353-303

Cymbalta

Duloxetine Hydrochloride

Cymbalta is a Oral Capsule, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, Llc. The primary component is Duloxetine Hydrochloride.

Product ID43353-303_061f7a95-4302-49fa-8ecf-9f9a55ef0f31
NDC43353-303
Product TypeHuman Prescription Drug
Proprietary NameCymbalta
Generic NameDuloxetine Hydrochloride
Dosage FormCapsule, Delayed Release
Route of AdministrationORAL
Marketing Start Date2004-08-24
Marketing CategoryNDA / NDA
Application NumberNDA021427
Labeler NameAphena Pharma Solutions - Tennessee, LLC
Substance NameDULOXETINE HYDROCHLORIDE
Active Ingredient Strength30 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 43353-303-19

3060 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43353-303-19)
Marketing Start Date2004-08-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43353-303-19 [43353030319]

Cymbalta CAPSULE, DELAYED RELEASE
Marketing CategoryNDA
Application NumberNDA021427
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2004-08-24
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
DULOXETINE HYDROCHLORIDE30 mg/1

OpenFDA Data

SPL SET ID:88b2461b-4a44-4899-b63d-bcecc754266f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 596932
  • 596930

    • 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
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.