NDC 0310-0274

SEROQUEL

Quetiapine Fumarate

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

Product ID0310-0274_0ea67c30-9548-480f-99de-7678dc88a648
NDC0310-0274
Product TypeHuman Prescription Drug
Proprietary NameSEROQUEL
Generic NameQuetiapine Fumarate
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2000-11-13
Marketing CategoryNDA / NDA
Application NumberNDA020639
Labeler NameAstraZeneca Pharmaceuticals LP
Substance NameQUETIAPINE FUMARATE
Active Ingredient Strength300 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0310-0274-60

60 TABLET, FILM COATED in 1 BOTTLE (0310-0274-60)
Marketing Start Date2000-11-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0310-0274-60 [00310027460]

SEROQUEL TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA020639
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2000-11-13

NDC 0310-0274-39 [00310027439]

SEROQUEL TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA020639
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2000-11-13
Marketing End Date2016-03-31

Drug Details

Active Ingredients

IngredientStrength
QUETIAPINE FUMARATE300 mg/1

OpenFDA Data

SPL SET ID:0584dda8-bc3c-48fe-1a90-79608f78e8a0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 317174
  • 616489
  • 284509
  • 616485
  • 616483
  • 616487
  • 153640
  • 312743
  • 153638
  • 153639
  • 312745
  • 312744
  • Pharmacological Class

    • Atypical Antipsychotic [EPC]

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

    NDCBrand NameGeneric Name
    21695-119SEROQUELSEROQUEL
    21695-117SEROQUELSEROQUEL
    21695-118SEROQUELSEROQUEL
    21695-120SEROQUELSEROQUEL
    55289-447SEROQUELSEROQUEL
    55289-187SEROQUELSEROQUEL
    55289-872SEROQUELSEROQUEL
    0310-0274SEROQUELSEROQUEL
    0310-0278SEROQUELSEROQUEL
    0310-0271SEROQUELSEROQUEL
    0310-0272SEROQUELSEROQUEL
    0310-0279SEROQUELSEROQUEL
    0310-0275SEROQUELSEROQUEL
    63629-3378SEROQUELSEROQUEL
    63629-3291SEROQUELSEROQUEL
    63629-3380SEROQUELSEROQUEL
    63629-3319SEROQUELSEROQUEL
    67046-666SEROQUELSEROQUEL
    67046-662SEROQUELSEROQUEL
    67046-664SEROQUELSEROQUEL
    67046-661SEROQUELSEROQUEL
    67046-660SEROQUELSEROQUEL
    67046-663SEROQUELSEROQUEL
    70518-2166SEROQUELSEROQUEL
    70518-2424SEROQUELSEROQUEL
    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.