NDC 68788-9266

Duloxetine

Duloxetine

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

Product ID68788-9266_5d221d55-c59f-43bc-b710-6902c3bdb0d0
NDC68788-9266
Product TypeHuman Prescription Drug
Proprietary NameDuloxetine
Generic NameDuloxetine
Dosage FormCapsule, Delayed Release Pellets
Route of AdministrationORAL
Marketing Start Date2014-11-18
Marketing CategoryANDA / ANDA
Application NumberANDA090723
Labeler NamePreferred Pharmaceuticals, Inc.
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 68788-9266-1

10 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68788-9266-1)
Marketing Start Date2014-11-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68788-9266-9 [68788926609]

Duloxetine CAPSULE, DELAYED RELEASE PELLETS
Marketing CategoryANDA
Application NumberANDA090723
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-11-18
Marketing End Date2019-09-03

NDC 68788-9266-2 [68788926602]

Duloxetine CAPSULE, DELAYED RELEASE PELLETS
Marketing CategoryANDA
Application NumberANDA090723
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-11-18
Marketing End Date2019-09-03

NDC 68788-9266-3 [68788926603]

Duloxetine CAPSULE, DELAYED RELEASE PELLETS
Marketing CategoryANDA
Application NumberANDA090723
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-11-18
Marketing End Date2019-09-03

NDC 68788-9266-0 [68788926600]

Duloxetine CAPSULE, DELAYED RELEASE PELLETS
Marketing CategoryANDA
Application NumberANDA090723
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-11-18
Marketing End Date2019-09-03

NDC 68788-9266-6 [68788926606]

Duloxetine CAPSULE, DELAYED RELEASE PELLETS
Marketing CategoryANDA
Application NumberANDA090723
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-11-18
Marketing End Date2019-09-03

NDC 68788-9266-1 [68788926601]

Duloxetine CAPSULE, DELAYED RELEASE PELLETS
Marketing CategoryANDA
Application NumberANDA090723
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-11-18
Marketing End Date2019-09-03

Drug Details

Active Ingredients

IngredientStrength
DULOXETINE HYDROCHLORIDE30 mg/1

OpenFDA Data

SPL SET ID:e89e6f78-1769-42de-828b-376893a40710
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 596930

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0093-7542DuloxetineDuloxetine
    0093-7543DuloxetineDuloxetine
    0093-7544DuloxetineDuloxetine
    0228-2890DuloxetineDuloxetine
    0228-2891DuloxetineDuloxetine
    0228-2892DuloxetineDuloxetine
    0904-7043DuloxetineDuloxetine Hydrochloride
    0904-7044DuloxetineDuloxetine Hydrochloride
    0904-7045DuloxetineDuloxetine Hydrochloride
    23155-654duloxetineduloxetine
    23155-655duloxetineduloxetine
    23155-656duloxetineduloxetine
    25000-608DuloxetineDuloxetine Hydrochloride
    25000-609DuloxetineDuloxetine Hydrochloride
    25000-610DuloxetineDuloxetine Hydrochloride
    27241-097DuloxetineDuloxetine
    27241-098DuloxetineDuloxetine
    67877-264DuloxetineDuloxetine
    67877-265DuloxetineDuloxetine
    67877-263DuloxetineDuloxetine
    68001-255DuloxetineDuloxetine
    68001-256DuloxetineDuloxetine
    68001-257DuloxetineDuloxetine
    68071-4700DuloxetineDuloxetine
    68084-692DuloxetineDuloxetine
    68084-675DuloxetineDuloxetine
    68084-683DuloxetineDuloxetine
    68151-4727DuloxetineDuloxetine
    68180-294DuloxetineDuloxetine
    68180-297DuloxetineDuloxetine
    68180-295DuloxetineDuloxetine
    68180-296DuloxetineDuloxetine
    68382-385DuloxetineDuloxetine
    68382-386DuloxetineDuloxetine
    68382-387DuloxetineDuloxetine
    68788-6427duloxetineduloxetine
    68788-9262DuloxetineDuloxetine
    68788-9266DuloxetineDuloxetine
    69097-298duloxetineduloxetine
    69097-297duloxetineduloxetine
    69097-299duloxetineduloxetine
    70518-0491DuloxetineDuloxetine
    70518-1066DuloxetineDuloxetine
    70518-0937DuloxetineDuloxetine
    70518-1054DuloxetineDuloxetine
    70518-1139DuloxetineDuloxetine
    70518-0685DuloxetineDuloxetine
    70518-1128DULOXETINEDULOXETINE
    70518-1011DuloxetineDuloxetine
    70518-1244DuloxetineDuloxetine
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