NDC 70518-2166

SEROQUEL

Quetiapine Fumarate

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

Product ID70518-2166_8cc3cd50-6162-392c-e053-2a95a90a1419
NDC70518-2166
Product TypeHuman Prescription Drug
Proprietary NameSEROQUEL
Generic NameQuetiapine Fumarate
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-06-28
Marketing CategoryNDA / NDA
Application NumberNDA020639
Labeler NameREMEDYREPACK INC.
Substance NameQUETIAPINE FUMARATE
Active Ingredient Strength300 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70518-2166-0

30 TABLET, FILM COATED in 1 BLISTER PACK (70518-2166-0)
Marketing Start Date2019-06-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-2166-0 [70518216600]

SEROQUEL TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA020639
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-06-28

Drug Details

Active Ingredients

IngredientStrength
QUETIAPINE FUMARATE300 mg/1

OpenFDA Data

SPL SET ID:a294b81f-be97-437b-89fb-ac8ec8fd17b3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 284509
  • 312745
  • 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

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