NDC 35356-491

Pristiq Extended-Release

Desvenlafaxine Succinate

Pristiq Extended-Release is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc. The primary component is Desvenlafaxine Succinate.

Product ID35356-491_521b234d-3eda-4c65-9d0e-38deb126d1c4
NDC35356-491
Product TypeHuman Prescription Drug
Proprietary NamePristiq Extended-Release
Generic NameDesvenlafaxine Succinate
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2012-04-16
Marketing CategoryNDA / NDA
Application NumberNDA021992
Labeler NameLake Erie Medical & Surgical Supply DBA Quality Care Products LLC
Substance NameDESVENLAFAXINE SUCCINATE
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 Through2019-12-31

Packaging

NDC 35356-491-30

30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (35356-491-30)
Marketing Start Date2012-04-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 35356-491-30 [35356049130]

Pristiq Extended-Release TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA021992
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-04-16
Marketing End Date2019-10-11

Drug Details

Active Ingredients

IngredientStrength
DESVENLAFAXINE SUCCINATE50 mg/1

OpenFDA Data

SPL SET ID:4d5d349b-94a2-45a6-a33b-777ee8cfb8b0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1874559
  • 790290

    • 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 "Pristiq Extended-Release" or generic name "Desvenlafaxine Succinate"

    NDCBrand NameGeneric Name
    46708-540DesvenlafaxineDesvenlafaxine Succinate
    46708-541DesvenlafaxineDesvenlafaxine Succinate
    46708-542DesvenlafaxineDesvenlafaxine Succinate
    50090-5274DesvenlafaxineDesvenlafaxine Succinate
    50090-5293DesvenlafaxineDesvenlafaxine Succinate
    51991-006DesvenlafaxineDesvenlafaxine Succinate
    51991-311DesvenlafaxineDesvenlafaxine Succinate
    51991-312DesvenlafaxineDesvenlafaxine Succinate
    55700-577DesvenlafaxineDesvenlafaxine Succinate
    50090-4069Desvenlafaxine Succinatedesvenlafaxine succinate
    59762-1210Desvenlafaxine Succinatedesvenlafaxine succinate
    0008-1210Pristiqdesvenlafaxine succinate
    0008-1211Pristiqdesvenlafaxine succinate
    0008-1222Pristiqdesvenlafaxine succinate
    35356-491Pristiqdesvenlafaxine succinate
    43063-262Pristiqdesvenlafaxine succinate
    55154-4230Pristiqdesvenlafaxine succinate
    55154-4235Pristiqdesvenlafaxine succinate

    Trademark Results [Pristiq]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    PRISTIQ
    PRISTIQ
    88308904 5828994 Live/Registered
    Wyeth LLC
    2019-02-20
    PRISTIQ
    PRISTIQ
    78541902 3477940 Live/Registered
    WYETH LLC
    2005-01-04
    PRISTIQ
    PRISTIQ
    77200228 3521683 Live/Registered
    WYETH LLC
    2007-06-07
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.