NDC 70518-1744

Quetiapine Extended Release

Quetiapine

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

Product ID70518-1744_7f124d6a-62ae-68c4-e053-2991aa0a56c6
NDC70518-1744
Product TypeHuman Prescription Drug
Proprietary NameQuetiapine Extended Release
Generic NameQuetiapine
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2018-12-19
Marketing CategoryANDA / ANDA
Application NumberANDA209635
Labeler NameREMEDYREPACK INC.
Substance NameQUETIAPINE FUMARATE
Active Ingredient Strength400 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70518-1744-0

1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOX, UNIT-DOSE (70518-1744-0)
Marketing Start Date2018-12-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-1744-1 [70518174401]

Quetiapine Extended Release TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA209635
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-01-23

NDC 70518-1744-0 [70518174400]

Quetiapine Extended Release TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA209635
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-12-19

NDC 70518-1744-2 [70518174402]

Quetiapine Extended Release TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA209635
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-01-23

Drug Details

Active Ingredients

IngredientStrength
QUETIAPINE FUMARATE400 mg/1

OpenFDA Data

SPL SET ID:63d05070-f07b-43d0-8276-1ccea762e1a2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 721796

    • Pharmacological Class

    • Atypical Antipsychotic [EPC]

    NDC Crossover Matching brand name "Quetiapine Extended Release" or generic name "Quetiapine"

    NDCBrand NameGeneric Name
    70518-1744Quetiapine Extended ReleaseQuetiapine Extended Release
    70518-1823Quetiapine Extended ReleaseQuetiapine Extended Release
    71093-139Quetiapine Extended ReleaseQuetiapine Extended Release
    71093-136Quetiapine Extended ReleaseQuetiapine Extended Release
    71093-135Quetiapine Extended ReleaseQuetiapine Extended Release
    71093-138Quetiapine Extended ReleaseQuetiapine Extended Release
    71093-137Quetiapine Extended ReleaseQuetiapine Extended Release
    10135-657Quetiapine Extended ReleaseQuetiapine Extended Release
    10135-658Quetiapine Extended ReleaseQuetiapine Extended Release
    10135-659Quetiapine Extended ReleaseQuetiapine Extended Release
    10135-656Quetiapine Extended ReleaseQuetiapine Extended Release
    50228-382Quetiapine Extended ReleaseQuetiapine Extended Release
    50228-383Quetiapine Extended ReleaseQuetiapine Extended Release
    50228-380Quetiapine Extended ReleaseQuetiapine Extended Release
    50228-384Quetiapine Extended ReleaseQuetiapine Extended Release
    50228-381Quetiapine Extended ReleaseQuetiapine Extended Release
    0093-2063QuetiapineQuetiapine
    0093-8162QuetiapineQuetiapine
    0093-8163QuetiapineQuetiapine
    0093-8164QuetiapineQuetiapine
    0093-8165QuetiapineQuetiapine
    0093-8166QuetiapineQuetiapine
    0310-0271SEROQUELquetiapine
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