NDC 68788-7399

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 Preferred Pharmaceuticals Inc.. The primary component is Duloxetine Hydrochloride.

Product ID68788-7399_8e7ad585-2786-4c1c-8f5b-538ca35cff05
NDC68788-7399
Product TypeHuman Prescription Drug
Proprietary NameDULOXETINE DELAYED-RELEASE
Generic NameDuloxetine Hydrochloride
Dosage FormCapsule, Delayed Release Pellets
Route of AdministrationORAL
Marketing Start Date2016-09-30
Marketing CategoryANDA / ANDA
Application NumberANDA203088
Labeler NamePreferred Pharmaceuticals Inc.
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 68788-7399-2

20 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68788-7399-2)
Marketing Start Date2016-09-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68788-7399-1 [68788739901]

DULOXETINE DELAYED-RELEASE CAPSULE, DELAYED RELEASE PELLETS
Marketing CategoryANDA
Application NumberANDA203088
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-09-30

NDC 68788-7399-0 [68788739900]

DULOXETINE DELAYED-RELEASE CAPSULE, DELAYED RELEASE PELLETS
Marketing CategoryANDA
Application NumberANDA203088
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-09-30

NDC 68788-7399-9 [68788739909]

DULOXETINE DELAYED-RELEASE CAPSULE, DELAYED RELEASE PELLETS
Marketing CategoryANDA
Application NumberANDA203088
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-09-30

NDC 68788-7399-8 [68788739908]

DULOXETINE DELAYED-RELEASE CAPSULE, DELAYED RELEASE PELLETS
Marketing CategoryANDA
Application NumberANDA203088
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-09-04

NDC 68788-7399-6 [68788739906]

DULOXETINE DELAYED-RELEASE CAPSULE, DELAYED RELEASE PELLETS
Marketing CategoryANDA
Application NumberANDA203088
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-09-30

NDC 68788-7399-3 [68788739903]

DULOXETINE DELAYED-RELEASE CAPSULE, DELAYED RELEASE PELLETS
Marketing CategoryANDA
Application NumberANDA203088
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-09-30

NDC 68788-7399-2 [68788739902]

DULOXETINE DELAYED-RELEASE CAPSULE, DELAYED RELEASE PELLETS
Marketing CategoryANDA
Application NumberANDA203088
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-09-30

Drug Details

Active Ingredients

IngredientStrength
DULOXETINE HYDROCHLORIDE60 mg/1

OpenFDA Data

SPL SET ID:25928f19-fb38-4830-b117-b7b85c33febe
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 596934

    • 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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