NDC 68788-6380

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 ID68788-6380_d7784571-64c3-4b19-b838-32b644756ad4
NDC68788-6380
Product TypeHuman Prescription Drug
Proprietary NameDULOXETINE DELAYED-RELEASE
Generic NameDuloxetine Hydrochloride
Dosage FormCapsule, Delayed Release Pellets
Route of AdministrationORAL
Marketing Start Date2016-05-04
Marketing CategoryANDA / ANDA
Application NumberANDA203088
Labeler NamePreferred Pharmaceuticals Inc.
Substance NameDULOXETINE HYDROCHLORIDE
Active Ingredient Strength20 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 68788-6380-1

10 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68788-6380-1)
Marketing Start Date2016-05-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68788-6380-3 [68788638003]

DULOXETINE DELAYED-RELEASE CAPSULE, DELAYED RELEASE PELLETS
Marketing CategoryANDA
Application NumberANDA203088
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-05-04

NDC 68788-6380-6 [68788638006]

DULOXETINE DELAYED-RELEASE CAPSULE, DELAYED RELEASE PELLETS
Marketing CategoryANDA
Application NumberANDA203088
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-05-04

NDC 68788-6380-1 [68788638001]

DULOXETINE DELAYED-RELEASE CAPSULE, DELAYED RELEASE PELLETS
Marketing CategoryANDA
Application NumberANDA203088
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-05-04

NDC 68788-6380-0 [68788638000]

DULOXETINE DELAYED-RELEASE CAPSULE, DELAYED RELEASE PELLETS
Marketing CategoryANDA
Application NumberANDA203088
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-05-04

NDC 68788-6380-9 [68788638009]

DULOXETINE DELAYED-RELEASE CAPSULE, DELAYED RELEASE PELLETS
Marketing CategoryANDA
Application NumberANDA203088
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-05-04

NDC 68788-6380-2 [68788638002]

DULOXETINE DELAYED-RELEASE CAPSULE, DELAYED RELEASE PELLETS
Marketing CategoryANDA
Application NumberANDA203088
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-05-04

Drug Details

Active Ingredients

IngredientStrength
DULOXETINE HYDROCHLORIDE20 mg/1

OpenFDA Data

SPL SET ID:7000c48f-77f3-4447-b223-fde99886ed30
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.