NDC 71335-0509

DULOXETINE DELAYED-RELEASE

Duloxetine Hydrochloride

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

Product ID71335-0509_61697b4c-6f7b-4032-a10e-05e78a0d8506
NDC71335-0509
Product TypeHuman Prescription Drug
Proprietary NameDULOXETINE DELAYED-RELEASE
Generic NameDuloxetine Hydrochloride
Dosage FormCapsule, Delayed Release Pellets
Route of AdministrationORAL
Marketing Start Date2014-06-11
Marketing CategoryANDA / ANDA
Application NumberANDA203088
Labeler NameBryant Ranch Prepack
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 Through2019-12-31

Packaging

NDC 71335-0509-1

30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-0509-1)
Marketing Start Date2022-02-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71335-0509-4 [71335050904]

DULOXETINE DELAYED-RELEASE CAPSULE, DELAYED RELEASE PELLETS
Marketing CategoryANDA
Application NumberANDA203088
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-06-11
Marketing End Date2019-02-28

NDC 71335-0509-2 [71335050902]

DULOXETINE DELAYED-RELEASE CAPSULE, DELAYED RELEASE PELLETS
Marketing CategoryANDA
Application NumberANDA203088
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-06-11
Marketing End Date2019-02-28

NDC 71335-0509-6 [71335050906]

DULOXETINE DELAYED-RELEASE CAPSULE, DELAYED RELEASE PELLETS
Marketing CategoryANDA
Application NumberANDA203088
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-06-11
Marketing End Date2019-02-28

NDC 71335-0509-5 [71335050905]

DULOXETINE DELAYED-RELEASE CAPSULE, DELAYED RELEASE PELLETS
Marketing CategoryANDA
Application NumberANDA203088
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-06-11
Marketing End Date2019-02-28

NDC 71335-0509-1 [71335050901]

DULOXETINE DELAYED-RELEASE CAPSULE, DELAYED RELEASE PELLETS
Marketing CategoryANDA
Application NumberANDA203088
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-06-11
Marketing End Date2019-02-28

NDC 71335-0509-3 [71335050903]

DULOXETINE DELAYED-RELEASE CAPSULE, DELAYED RELEASE PELLETS
Marketing CategoryANDA
Application NumberANDA203088
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-06-11
Marketing End Date2019-02-28

Drug Details

Active Ingredients

IngredientStrength
DULOXETINE HYDROCHLORIDE60 mg/1

OpenFDA Data

SPL SET ID:a891f20f-83ff-4960-81ef-9e74d01a452e
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]

    NDC Crossover Matching brand name "DULOXETINE DELAYED-RELEASE" or generic name "Duloxetine Hydrochloride"

    NDCBrand NameGeneric Name
    68001-368Duloxetine Delayed-ReleaseDuloxetine Delayed-Release
    68788-6380DULOXETINE DELAYED-RELEASEDULOXETINE DELAYED-RELEASE
    68788-7399DULOXETINE DELAYED-RELEASEDULOXETINE DELAYED-RELEASE
    68788-9301DULOXETINE DELAYED-RELEASEDULOXETINE DELAYED-RELEASE
    70518-0122Duloxetine Delayed-ReleaseDuloxetine Delayed-Release
    70518-0343Duloxetine Delayed-ReleaseDuloxetine Delayed-Release
    70518-1802Duloxetine Delayed-ReleaseDuloxetine Delayed-Release
    71335-0509DULOXETINE DELAYED-RELEASEDULOXETINE DELAYED-RELEASE
    71335-0165DULOXETINE DELAYED-RELEASEDULOXETINE DELAYED-RELEASE
    71335-0392DULOXETINE DELAYED-RELEASEDULOXETINE DELAYED-RELEASE
    71610-218Duloxetine Delayed-ReleaseDuloxetine Delayed-Release
    43353-025DULOXETINE DELAYED-RELEASEDULOXETINE DELAYED-RELEASE
    43353-106DULOXETINE DELAYED-RELEASEDULOXETINE DELAYED-RELEASE
    43353-960DULOXETINE DELAYED-RELEASEDULOXETINE DELAYED-RELEASE
    45865-815Duloxetine Delayed-ReleaseDuloxetine Delayed-Release
    50090-3205Duloxetine Delayed-ReleaseDuloxetine Delayed-Release
    50090-3028Duloxetine Delayed-ReleaseDuloxetine Delayed-Release
    51991-750Duloxetine Delayed-ReleaseDuloxetine Delayed-Release
    51991-746Duloxetine Delayed-ReleaseDuloxetine Delayed-Release
    51991-747Duloxetine Delayed-ReleaseDuloxetine Delayed-Release
    51991-748Duloxetine Delayed-ReleaseDuloxetine Delayed-Release
    55700-505DULOXETINE DELAYED-RELEASEDULOXETINE DELAYED-RELEASE
    60429-164DULOXETINE DELAYED-RELEASEDULOXETINE DELAYED-RELEASE
    60429-166DULOXETINE DELAYED-RELEASEDULOXETINE DELAYED-RELEASE
    60429-165DULOXETINE DELAYED-RELEASEDULOXETINE DELAYED-RELEASE
    62034-021DULOXETINE DELAYED-RELEASEDULOXETINE DELAYED-RELEASE
    62034-029DULOXETINE DELAYED-RELEASEDULOXETINE DELAYED-RELEASE
    63187-702DULOXETINE DELAYED-RELEASEDULOXETINE DELAYED-RELEASE
    63187-720DULOXETINE DELAYED-RELEASEDULOXETINE DELAYED-RELEASE
    63187-735DULOXETINE DELAYED-RELEASEDULOXETINE DELAYED-RELEASE
    64725-0747DULOXETINE DELAYED-RELEASEDULOXETINE DELAYED-RELEASE
    50090-2226Duloxetine Delayed-ReleaseDuloxetine Delayed-Release
    68071-5104Duloxetine Delayed-ReleaseDuloxetine Delayed-Release
    0002-3235CymbaltaDuloxetine hydrochloride
    0002-3240CymbaltaDuloxetine hydrochloride
    0002-3270CymbaltaDuloxetine hydrochloride
    21695-145CymbaltaDuloxetine hydrochloride
    21695-146CymbaltaDuloxetine hydrochloride
    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
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