NDC 13668-111

Duloxetine hydrochloride

Duloxetin Hydrochloride

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

Product ID13668-111_3f71e6cf-d084-40c4-9c8d-573cda7001e0
NDC13668-111
Product TypeHuman Prescription Drug
Proprietary NameDuloxetine hydrochloride
Generic NameDuloxetin Hydrochloride
Dosage FormCapsule, Delayed Release
Route of AdministrationORAL
Marketing Start Date2013-12-11
Marketing CategoryANDA / ANDA
Application NumberANDA090774
Labeler NameTorrent Pharmaceuticals Limited
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 Through2020-12-31

Packaging

NDC 13668-111-01

100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (13668-111-01)
Marketing Start Date2013-12-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 13668-111-30 [13668011130]

Duloxetine hydrochloride CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA090774
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-12-11

NDC 13668-111-05 [13668011105]

Duloxetine hydrochloride CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA090774
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-12-11

NDC 13668-111-10 [13668011110]

Duloxetine hydrochloride CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA090774
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-12-11
Marketing End Date2019-08-22

NDC 13668-111-01 [13668011101]

Duloxetine hydrochloride CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA090774
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-12-11

NDC 13668-111-74 [13668011174]

Duloxetine hydrochloride CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA090774
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-12-11

Drug Details

Active Ingredients

IngredientStrength
DULOXETINE HYDROCHLORIDE60 mg/1

OpenFDA Data

SPL SET ID:b82656d8-e22e-42e5-9b97-887e6d09a68c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 596930
  • 596934
  • 596926
    • UPC Code
  • 0313668111057
  • 0313668109054
  • 0313668110050

    • Pharmacological Class

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

    Medicade Reported Pricing

    13668011130 DULOXETINE HCL DR 60 MG CAP

    Pricing Unit: EA | Drug Type:

    13668011105 DULOXETINE HCL DR 60 MG CAP

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Duloxetine hydrochloride" or generic name "Duloxetin 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
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