NDC 60505-2996

Duloxetine Hydrochloride

Duloxetine Hydrochloride

Duloxetine Hydrochloride is a Oral Capsule, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Apotex Corp.. The primary component is Duloxetine Hydrochloride.

Product ID60505-2996_525ba532-cd18-0af0-b283-d7690a13c385
NDC60505-2996
Product TypeHuman Prescription Drug
Proprietary NameDuloxetine Hydrochloride
Generic NameDuloxetine Hydrochloride
Dosage FormCapsule, Delayed Release
Route of AdministrationORAL
Marketing Start Date2014-06-13
Marketing CategoryANDA / ANDA
Application NumberANDA202045
Labeler NameApotex Corp.
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 Through2020-12-31

Packaging

NDC 60505-2996-3

30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (60505-2996-3)
Marketing Start Date2014-06-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 60505-2996-0 [60505299600]

Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA202045
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-06-13
Marketing End Date2016-11-17

NDC 60505-2996-8 [60505299608]

Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA202045
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-06-13

NDC 60505-2996-3 [60505299603]

Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA202045
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-06-13

NDC 60505-2996-6 [60505299606]

Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA202045
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-06-13

NDC 60505-2996-5 [60505299605]

Duloxetine Hydrochloride CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA202045
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-06-13

Drug Details

Active Ingredients

IngredientStrength
DULOXETINE HYDROCHLORIDE30 mg/1

OpenFDA Data

SPL SET ID:4abbc89a-4cbb-881e-fd9c-6912e5ce5cf4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 596930
  • 596934
  • 596926

    • Pharmacological Class

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

    Medicade Reported Pricing

    60505299605 DULOXETINE HCL DR 30 MG CAP

    Pricing Unit: EA | Drug Type:

    60505299603 DULOXETINE HCL DR 30 MG CAP

    Pricing Unit: EA | Drug Type:

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

    NDCBrand NameGeneric Name
    0615-7894Duloxetine hydrochlorideDuloxetin hydrochloride
    0615-7895Duloxetine hydrochlorideDuloxetin hydrochloride
    0615-8034Duloxetine HydrochlorideDuloxetine Hydrochloride
    0615-8035Duloxetine HydrochlorideDuloxetine Hydrochloride
    0615-8203Duloxetine hydrochlorideDuloxetin hydrochloride
    0615-8204Duloxetine hydrochlorideDuloxetin hydrochloride
    0615-8290Duloxetine hydrochlorideDuloxetin hydrochloride
    0904-6452Duloxetine HydrochlorideDuloxetine Hydrochloride
    0904-6453Duloxetine HydrochlorideDuloxetine Hydrochloride
    0904-6454Duloxetine HydrochlorideDuloxetine Hydrochloride
    68788-9370Duloxetine HydrochlorideDuloxetine Hydrochloride
    68788-9371Duloxetine HydrochlorideDuloxetine Hydrochloride
    70518-0716Duloxetine HydrochlorideDuloxetine Hydrochloride
    70518-0363Duloxetine hydrochlorideDuloxetine hydrochloride
    70518-0686Duloxetine HydrochlorideDuloxetine Hydrochloride
    70518-1273Duloxetine hydrochlorideDuloxetine hydrochloride
    70518-1272Duloxetine hydrochlorideDuloxetine hydrochloride
    13668-110Duloxetine hydrochlorideDuloxetine hydrochloride
    13668-109Duloxetine hydrochlorideDuloxetine hydrochloride
    13668-111Duloxetine hydrochlorideDuloxetine hydrochloride
    33342-162Duloxetine HydrochlorideDuloxetine Hydrochloride
    33342-160Duloxetine HydrochlorideDuloxetine Hydrochloride
    33342-161Duloxetine HydrochlorideDuloxetine Hydrochloride
    50090-3317Duloxetine HydrochlorideDuloxetine Hydrochloride
    50436-2996Duloxetine HydrochlorideDuloxetine Hydrochloride
    50436-2997Duloxetine HydrochlorideDuloxetine Hydrochloride
    50436-0018Duloxetine HydrochlorideDuloxetine Hydrochloride
    55154-7878Duloxetine HydrochlorideDuloxetine Hydrochloride
    55700-165Duloxetine HydrochlorideDuloxetine Hydrochloride
    55700-160Duloxetine HydrochlorideDuloxetine Hydrochloride
    55700-435Duloxetine HydrochlorideDuloxetine Hydrochloride
    60505-2997Duloxetine HydrochlorideDuloxetine Hydrochloride
    60505-2996Duloxetine HydrochlorideDuloxetine Hydrochloride
    60505-2995Duloxetine HydrochlorideDuloxetine Hydrochloride
    61919-042DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDE
    61919-482DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDE
    63187-181Duloxetine HydrochlorideDuloxetine Hydrochloride
    63187-457Duloxetine hydrochlorideDuloxetine hydrochloride
    63187-172Duloxetine HydrochlorideDuloxetine Hydrochloride
    63187-716Duloxetine HydrochlorideDuloxetine Hydrochloride
    64725-1100Duloxetine hydrochlorideDuloxetine hydrochloride
    55154-7889Duloxetine HydrochlorideDuloxetine Hydrochloride
    0002-3235CymbaltaDuloxetine hydrochloride
    0002-3240CymbaltaDuloxetine hydrochloride
    0002-3270CymbaltaDuloxetine hydrochloride
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.