NDC 70518-0646

Quetiapine Fumarate Extended Release

Quetiapine Fumarate

Quetiapine Fumarate 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 ID70518-0646_55a5a95a-eeb1-6eb9-e054-00144ff8d46c
NDC70518-0646
Product TypeHuman Prescription Drug
Proprietary NameQuetiapine Fumarate Extended Release
Generic NameQuetiapine Fumarate
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2017-07-28
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA022047
Labeler NameREMEDYREPACK INC.
Substance NameQUETIAPINE FUMARATE
Active Ingredient Strength200 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 70518-0646-0

30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (70518-0646-0)
Marketing Start Date2017-07-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-0646-0 [70518064600]

Quetiapine Fumarate Extended Release TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryNDA authorized generic
Application NumberNDA022047
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-07-28
Marketing End Date2020-03-30

Drug Details

Active Ingredients

IngredientStrength
QUETIAPINE FUMARATE200 mg/1

OpenFDA Data

SPL SET ID:569344c0-bf2c-49f2-97fd-4af1000d4758
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 721791

    • Pharmacological Class

    • Atypical Antipsychotic [EPC]

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

    NDCBrand NameGeneric Name
    70518-0646Quetiapine Fumarate Extended ReleaseQuetiapine Fumarate Extended Release
    49884-807Quetiapine Fumarate Extended ReleaseQuetiapine Fumarate Extended Release
    49884-805Quetiapine Fumarate Extended ReleaseQuetiapine Fumarate Extended Release
    49884-808Quetiapine Fumarate Extended ReleaseQuetiapine Fumarate Extended Release
    49884-806Quetiapine Fumarate Extended ReleaseQuetiapine Fumarate Extended Release
    0310-8280Quetiapine Fumarate Extended ReleaseQuetiapine Fumarate Extended Release
    0310-8282Quetiapine Fumarate Extended ReleaseQuetiapine Fumarate Extended Release
    0310-8283Quetiapine Fumarate Extended ReleaseQuetiapine Fumarate Extended Release
    0310-8284Quetiapine Fumarate Extended ReleaseQuetiapine Fumarate Extended Release
    0310-8281Quetiapine Fumarate Extended ReleaseQuetiapine Fumarate Extended Release
    0054-0220Quetiapine FumarateQuetiapine Fumarate
    0054-0221Quetiapine FumarateQuetiapine Fumarate
    0054-0222Quetiapine FumarateQuetiapine Fumarate
    0054-0223Quetiapine FumarateQuetiapine Fumarate
    0054-0229Quetiapine FumarateQuetiapine Fumarate
    0054-0230Quetiapine FumarateQuetiapine Fumarate
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.