NDC 63629-3291

SEROQUEL

Quetiapine

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

Product ID63629-3291_0890b8e2-4987-4e32-b329-ace49177aad8
NDC63629-3291
Product TypeHuman Prescription Drug
Proprietary NameSEROQUEL
Generic NameQuetiapine
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date1997-10-01
Marketing CategoryNDA / NDA
Application NumberNDA020639
Labeler NameBryant Ranch Prepack
Substance NameQUETIAPINE FUMARATE
Active Ingredient Strength100 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 63629-3291-1

100 TABLET, FILM COATED in 1 BOTTLE (63629-3291-1)
Marketing Start Date2009-03-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63629-3291-1 [63629329101]

SEROQUEL TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA020639
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1997-10-01
Inactivation Date2019-11-27

NDC 63629-3291-2 [63629329102]

SEROQUEL TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA020639
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1997-10-01
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
QUETIAPINE FUMARATE100 mg/1

OpenFDA Data

SPL SET ID:8263025b-d82d-4ec4-b70f-8b9742c2ea4b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 312743
  • 153639
  • Pharmacological Class

    • Atypical Antipsychotic [EPC]

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

    NDCBrand NameGeneric Name
    0310-0271SEROQUELQuetiapine fumarate
    21695-119SEROQUELSEROQUEL
    21695-117SEROQUELSEROQUEL
    21695-118SEROQUELSEROQUEL
    21695-120SEROQUELSEROQUEL
    55289-447SEROQUELSEROQUEL
    55289-187SEROQUELSEROQUEL
    55289-872SEROQUELSEROQUEL
    0310-0274SEROQUELSEROQUEL
    0310-0278SEROQUELSEROQUEL
    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
    0093-2063QuetiapineQuetiapine
    0093-8162QuetiapineQuetiapine
    0093-8163QuetiapineQuetiapine
    0093-8164QuetiapineQuetiapine
    0093-8165QuetiapineQuetiapine
    0093-8166QuetiapineQuetiapine

    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.