NDC 65224-880

KHEDEZLA Extended-release

Desvenlafaxine

KHEDEZLA Extended-release is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Pernix Therapeutics. The primary component is Desvenlafaxine.

Product ID65224-880_158a198b-948b-4ad9-a578-277ccc47d41c
NDC65224-880
Product TypeHuman Prescription Drug
Proprietary NameKHEDEZLA Extended-release
Generic NameDesvenlafaxine
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2013-07-10
Marketing CategoryNDA / NDA
Application NumberNDA204683
Labeler NamePernix Therapeutics
Substance NameDESVENLAFAXINE
Active Ingredient Strength50 mg/1
Pharm ClassesNorepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 65224-880-31

30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (65224-880-31)
Marketing Start Date2013-07-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65224-880-90 [65224088090]

KHEDEZLA Extended-release TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA204683
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-07-10
Marketing End Date2020-01-31

NDC 65224-880-31 [65224088031]

KHEDEZLA Extended-release TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA204683
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-07-10
Marketing End Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
DESVENLAFAXINE50 mg/1

OpenFDA Data

SPL SET ID:130b1f08-7b46-4f72-b3ff-03812687d8ce
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 790288
  • 1435480
  • 790264
  • 1435483
  • Pharmacological Class

    • Norepinephrine Uptake Inhibitors [MoA]
    • Serotonin and Norepinephrine Reuptake Inhibitor [EPC]
    • Serotonin Uptake Inhibitors [MoA]
    • Cytochrome P450 2D6 Inhibitors [MoA]

    NDC Crossover Matching brand name "KHEDEZLA Extended-release" or generic name "Desvenlafaxine"

    NDCBrand NameGeneric Name
    65224-880KHEDEZLA Extended-releaseKHEDEZLA Extended-release
    65224-890KHEDEZLA Extended-releaseKHEDEZLA Extended-release
    0054-0400DesvenlafaxineDesvenlafaxine
    0054-0401DesvenlafaxineDesvenlafaxine
    0054-0603DesvenlafaxineDesvenlafaxine
    0378-4230Desvenlafaxinedesvenlafaxine
    0378-4231Desvenlafaxinedesvenlafaxine
    0591-3659DesvenlafaxineDesvenlafaxine
    0591-3660DesvenlafaxineDesvenlafaxine
    0591-4060DesvenlafaxineDesvenlafaxine
    35208-009DesvenlafaxineDesvenlafaxine
    35208-010DesvenlafaxineDesvenlafaxine
    44183-880Desvenlafaxinedesvenlafaxine
    44183-890Desvenlafaxinedesvenlafaxine
    46708-152DesvenlafaxineDesvenlafaxine
    46708-153DesvenlafaxineDesvenlafaxine
    50090-4388DesvenlafaxineDesvenlafaxine
    50090-4806DesvenlafaxineDesvenlafaxine
    51407-021DesvenlafaxineDesvenlafaxine
    51407-022DesvenlafaxineDesvenlafaxine

    Trademark Results [KHEDEZLA]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    KHEDEZLA
    KHEDEZLA
    85814727 4692875 Live/Registered
    OSMOTICA COMMERCIAL AND SERVICES
    2013-01-03

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