NDC 0310-8281

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 Astrazeneca Pharmaceuticals Lp. The primary component is Quetiapine Fumarate.

Product ID0310-8281_2d82279e-fa55-47a5-9549-fcb1ed842818
NDC0310-8281
Product TypeHuman Prescription Drug
Proprietary NameQuetiapine Fumarate Extended Release
Generic NameQuetiapine Fumarate
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2017-05-01
Marketing End Date2020-07-31
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA022047
Labeler NameAstraZeneca Pharmaceuticals LP
Substance NameQUETIAPINE FUMARATE
Active Ingredient Strength150 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN

Packaging

NDC 0310-8281-60

60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0310-8281-60)
Marketing Start Date2017-05-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0310-8281-60 [00310828160]

Quetiapine Fumarate Extended Release TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryNDA authorized generic
Application NumberNDA022047
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-05-01
Marketing End Date2020-07-31

Drug Details

Active Ingredients

IngredientStrength
QUETIAPINE FUMARATE150 mg/1

OpenFDA Data

SPL SET ID:7283b14f-023d-466f-a7eb-4356803d7c65
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 721796
  • 853201
  • 721794
  • 895670
  • 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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.