NDC 0310-0282

SEROQUEL XR

Quetiapine Fumarate

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

Product ID0310-0282_130a4121-4ea4-463e-8ba3-e30f35455f1d
NDC0310-0282
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 NameAstraZeneca Pharmaceuticals LP
Substance NameQUETIAPINE FUMARATE
Active Ingredient Strength200 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0310-0282-60

60 TABLET, EXTENDED RELEASE in 1 BOTTLE (0310-0282-60)
Marketing Start Date2007-07-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0310-0282-94 [00310028294]

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

NDC 0310-0282-50 [00310028250]

SEROQUEL XR TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA022047
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-07-16
Marketing End Date2011-03-23

NDC 0310-0282-60 [00310028260]

SEROQUEL XR TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA022047
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-07-16

NDC 0310-0282-39 [00310028239]

SEROQUEL XR TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA022047
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-07-16
Marketing End Date2019-10-31

Drug Details

Active Ingredients

IngredientStrength
QUETIAPINE FUMARATE200 mg/1

OpenFDA Data

SPL SET ID:473a3ac4-67f4-4782-baa9-7f9bdd8761f4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 895671
  • 895670
  • 1648646
  • 853201
  • 853202
  • 1648647
  • 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
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.