NDC 71335-0367

Duloxetine

Duloxetine Hydrochloride

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

Product ID71335-0367_fe99d219-4cba-4545-8417-95b0c7c5b12a
NDC71335-0367
Product TypeHuman Prescription Drug
Proprietary NameDuloxetine
Generic NameDuloxetine Hydrochloride
Dosage FormCapsule, Delayed Release
Route of AdministrationORAL
Marketing Start Date2013-12-11
Marketing CategoryANDA / ANDA
Application NumberANDA090778
Labeler NameBryant Ranch Prepack
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 71335-0367-2

60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0367-2)
Marketing Start Date2014-09-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71335-0367-2 [71335036702]

Duloxetine CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA090778
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-09-26
Marketing End Date2018-08-31

NDC 71335-0367-4 [71335036704]

Duloxetine CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA090778
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-09-26
Marketing End Date2018-08-31

NDC 71335-0367-6 [71335036706]

Duloxetine CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA090778
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-09-26
Marketing End Date2018-08-31

NDC 71335-0367-3 [71335036703]

Duloxetine CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA090778
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-09-26
Marketing End Date2018-08-31

NDC 71335-0367-7 [71335036707]

Duloxetine CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA090778
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-09-26
Marketing End Date2018-08-31

NDC 71335-0367-5 [71335036705]

Duloxetine CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA090778
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-09-26
Marketing End Date2018-08-31

NDC 71335-0367-1 [71335036701]

Duloxetine CAPSULE, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA090778
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-09-26
Marketing End Date2018-08-31

Drug Details

Active Ingredients

IngredientStrength
DULOXETINE HYDROCHLORIDE30 mg/1

OpenFDA Data

SPL SET ID:09f86d20-da47-4016-8404-875fafe52865
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 Hydrochloride"

    NDCBrand NameGeneric Name
    0093-7542DuloxetineDuloxetine
    0093-7543DuloxetineDuloxetine
    0093-7544DuloxetineDuloxetine
    0228-2890DuloxetineDuloxetine
    0228-2891DuloxetineDuloxetine
    0228-2892DuloxetineDuloxetine
    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
    70518-1137DuloxetineDuloxetine
    70518-1765DuloxetineDuloxetine
    70710-1537DuloxetineDuloxetine
    70518-1891DuloxetineDuloxetine
    70710-1538DuloxetineDuloxetine
    70771-1344DuloxetineDuloxetine
    70710-1539DuloxetineDuloxetine
    70771-1346DuloxetineDuloxetine
    70771-1345DuloxetineDuloxetine
    71205-005DuloxetineDuloxetine
    71335-0367DuloxetineDuloxetine
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