NDC 64725-0282

SEROQUEL XR

Quetiapine Fumarate

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

Product ID64725-0282_09f9c7b9-7622-4089-b6b9-8e5be366a398
NDC64725-0282
Product TypeHuman Prescription Drug
Proprietary NameSEROQUEL XR
Generic NameQuetiapine Fumarate
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2007-07-16
Marketing CategoryNDA / NDA
Application NumberNDA022047
Labeler NameTYA Pharmaceuticals
Substance NameQUETIAPINE FUMARATE
Active Ingredient Strength200 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 64725-0282-1

60 TABLET, EXTENDED RELEASE in 1 BOTTLE (64725-0282-1)
Marketing Start Date2007-07-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 64725-0282-1 [64725028201]

SEROQUEL XR TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA022047
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-07-16
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
QUETIAPINE FUMARATE200 mg/1

OpenFDA Data

SPL SET ID:51927f2e-3d56-4644-a6a8-40e0b9a5b579
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 895671
  • 895670
  • 853201
  • 853202
  • 721796
  • 721797
  • 721794
  • 721795
  • 721793
  • 721791

    • 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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.