NDC 51991-750

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 Breckenridge Pharmaceutical, Inc.. The primary component is Duloxetine Hydrochloride.

Product ID51991-750_3deaf871-63e4-4dfc-aa43-015595082a95
NDC51991-750
Product TypeHuman Prescription Drug
Proprietary NameDuloxetine Delayed-Release
Generic NameDuloxetine Hydrochloride
Dosage FormCapsule, Delayed Release Pellets
Route of AdministrationORAL
Marketing Start Date2018-05-21
Marketing CategoryANDA / ANDA
Application NumberANDA203088
Labeler NameBreckenridge Pharmaceutical, Inc.
Substance NameDULOXETINE HYDROCHLORIDE
Active Ingredient Strength40 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 51991-750-05

500 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (51991-750-05)
Marketing Start Date2018-05-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51991-750-05 [51991075005]

Duloxetine Delayed-Release CAPSULE, DELAYED RELEASE PELLETS
Marketing CategoryANDA
Application NumberANDA203088
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-05-21

NDC 51991-750-10 [51991075010]

Duloxetine Delayed-Release CAPSULE, DELAYED RELEASE PELLETS
Marketing CategoryANDA
Application NumberANDA203088
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-05-21

NDC 51991-750-90 [51991075090]

Duloxetine Delayed-Release CAPSULE, DELAYED RELEASE PELLETS
Marketing CategoryANDA
Application NumberANDA203088
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-05-21

NDC 51991-750-33 [51991075033]

Duloxetine Delayed-Release CAPSULE, DELAYED RELEASE PELLETS
Marketing CategoryANDA
Application NumberANDA203088
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-05-21

Drug Details

Active Ingredients

IngredientStrength
DULOXETINE HYDROCHLORIDE40 mg/1

OpenFDA Data

SPL SET ID:caef6f50-1571-4ec7-8f8c-42b924d323ee
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 596930
  • 616402
  • 596934
  • 596926
    • UPC Code
  • 0351991750338
  • 0351991746904

    • Pharmacological Class

    • Norepinephrine Uptake Inhibitors [MoA]
    • Serotonin and Norepinephrine Reuptake Inhibitor [EPC]
    • Serotonin Uptake Inhibitors [MoA]

    Medicade Reported Pricing

    51991075033 DULOXETINE HCL DR 40 MG CAP

    Pricing Unit: EA | Drug Type:

    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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