NDC 70518-1823

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 ID70518-1823_840333e5-0693-3d23-e053-2a91aa0a79f5
NDC70518-1823
Product TypeHuman Prescription Drug
Proprietary NameQuetiapine Extended Release
Generic NameQuetiapine
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2019-01-24
Marketing CategoryANDA / ANDA
Application NumberANDA209635
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 70518-1823-0

30 POUCH in 1 BOX, UNIT-DOSE (70518-1823-0) > 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 POUCH (70518-1823-1)
Marketing Start Date2019-01-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-1823-0 [70518182300]

Quetiapine Extended Release TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA209635
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-01-24

NDC 70518-1823-1 [70518182301]

Quetiapine Extended Release TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA209635
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-01-24

Drug Details

Active Ingredients

IngredientStrength
QUETIAPINE FUMARATE300 mg/1

OpenFDA Data

SPL SET ID:ca10f65e-cd04-4627-8a85-00c115e4c664
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 721794

    • Pharmacological Class

    • Atypical Antipsychotic [EPC]
    • 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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