NDC 49884-808

Quetiapine Fumarate Extended Release

Quetiapine Fumarate

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

Product ID49884-808_3d8d897b-1740-421d-9352-aa5ffae55179
NDC49884-808
Product TypeHuman Prescription Drug
Proprietary NameQuetiapine Fumarate Extended Release
Generic NameQuetiapine Fumarate
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2016-11-01
Marketing End Date2019-08-31
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA022047
Labeler NamePar Pharmaceutical Inc.
Substance NameQUETIAPINE FUMARATE
Active Ingredient Strength300 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN

Packaging

NDC 49884-808-02

60 TABLET, EXTENDED RELEASE in 1 BOTTLE (49884-808-02)
Marketing Start Date2016-11-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49884-808-02 [49884080802]

Quetiapine Fumarate Extended Release TABLET, EXTENDED RELEASE
Marketing CategoryNDA authorized generic
Application NumberNDA022047
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-11-01
Marketing End Date2019-08-31

Drug Details

Active Ingredients

IngredientStrength
QUETIAPINE FUMARATE300 mg/1

OpenFDA Data

SPL SET ID:6fb9a3e0-5ba1-4092-b9ca-3f3b5d666e0e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 853201
  • 721794
  • 895670
  • 721791
    • UPC Code
  • 0349884806026
  • 0349884805029
  • 0349884808020
  • 0349884807023

    • Pharmacological Class

    • Atypical Antipsychotic [EPC]

    Medicade Reported Pricing

    49884080802 QUETIAPINE ER 300 MG TABLET

    Pricing Unit: EA | Drug Type:

    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
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