NDC 69189-0484

SEROQUEL XR

Quetiapine Fumarate

SEROQUEL XR is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Avera Mckennan Hospital. The primary component is Quetiapine Fumarate.

Product ID69189-0484_adff3967-150b-47c7-b047-03458ee7a47d
NDC69189-0484
Product TypeHuman Prescription Drug
Proprietary NameSEROQUEL XR
Generic NameQuetiapine Fumarate
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2016-01-13
Marketing CategoryNDA / NDA
Application NumberNDA022047
Labeler NameAvera McKennan Hospital
Substance NameQUETIAPINE FUMARATE
Active Ingredient Strength300 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 69189-0484-1

1 TABLET, EXTENDED RELEASE in 1 DOSE PACK (69189-0484-1)
Marketing Start Date2016-01-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69189-0484-1 [69189048401]

SEROQUEL XR TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA022047
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-01-13
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
QUETIAPINE FUMARATE300 mg/1

OpenFDA Data

SPL SET ID:63cf6e35-4d68-4316-8579-823419f386de
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 721794
  • 721795

    • Pharmacological Class

    • Atypical Antipsychotic [EPC]

    NDC Crossover Matching brand name "SEROQUEL XR" or generic name "Quetiapine Fumarate"

    NDCBrand NameGeneric Name
    69189-0484SEROQUEL XRSEROQUEL XR
    0310-0281SEROQUEL XRSEROQUEL XR
    0310-0284SEROQUEL XRSEROQUEL XR
    0310-0282SEROQUEL XRSEROQUEL XR
    0310-0297SEROQUEL XRSEROQUEL XR
    0310-0280SEROQUEL XRSEROQUEL XR
    0310-0283SEROQUEL XRSEROQUEL XR
    64725-0281SEROQUEL XRSEROQUEL XR
    64725-0282SEROQUEL XRSEROQUEL XR
    64725-0280SEROQUEL XRSEROQUEL XR
    64725-0284SEROQUEL XRSEROQUEL XR
    64725-0283SEROQUEL XRSEROQUEL XR
    0054-0220Quetiapine FumarateQuetiapine Fumarate
    0054-0221Quetiapine FumarateQuetiapine Fumarate
    0054-0222Quetiapine FumarateQuetiapine Fumarate
    0054-0223Quetiapine FumarateQuetiapine Fumarate
    0054-0229Quetiapine FumarateQuetiapine Fumarate
    0054-0230Quetiapine FumarateQuetiapine Fumarate

    Trademark Results [SEROQUEL]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    SEROQUEL
    SEROQUEL
    73724400 1517746 Live/Registered
    IMPERIAL CHEMICAL INDUSTRIES PLC
    1988-04-25
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