NDC 70518-1802

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 Remedyrepack Inc.. The primary component is Duloxetine Hydrochloride.

Product ID70518-1802_7fb26264-f629-34ea-e053-2991aa0afe0f
NDC70518-1802
Product TypeHuman Prescription Drug
Proprietary NameDuloxetine Delayed-Release
Generic NameDuloxetine Hydrochloride
Dosage FormCapsule, Delayed Release Pellets
Route of AdministrationORAL
Marketing Start Date2019-01-17
Marketing CategoryANDA / ANDA
Application NumberANDA203088
Labeler NameREMEDYREPACK 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 Through2020-12-31

Packaging

NDC 70518-1802-1

30 POUCH in 1 BOX (70518-1802-1) > 1 CAPSULE, DELAYED RELEASE PELLETS in 1 POUCH (70518-1802-2)
Marketing Start Date2019-07-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-1802-2 [70518180202]

Duloxetine Delayed-Release CAPSULE, DELAYED RELEASE PELLETS
Marketing CategoryANDA
Application NumberANDA203088
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-09

NDC 70518-1802-0 [70518180200]

Duloxetine Delayed-Release CAPSULE, DELAYED RELEASE PELLETS
Marketing CategoryANDA
Application NumberANDA203088
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-01-17

NDC 70518-1802-1 [70518180201]

Duloxetine Delayed-Release CAPSULE, DELAYED RELEASE PELLETS
Marketing CategoryANDA
Application NumberANDA203088
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-09

Drug Details

Active Ingredients

IngredientStrength
DULOXETINE HYDROCHLORIDE30 mg/1

OpenFDA Data

SPL SET ID:6a92b01f-fd93-4100-b42f-ccd63bc54827
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 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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