NDC 65862-874

Quetiapine Fumarate

Quetiapine

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

Product ID65862-874_16429227-b3bd-49bc-8a6a-63d0f53c9017
NDC65862-874
Product TypeHuman Prescription Drug
Proprietary NameQuetiapine Fumarate
Generic NameQuetiapine
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2017-11-29
Marketing CategoryANDA / ANDA
Application NumberANDA207655
Labeler NameAurobindo Pharma Limited
Substance NameQUETIAPINE FUMARATE
Active Ingredient Strength150 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 65862-874-01

100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-874-01)
Marketing Start Date2017-11-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65862-874-05 [65862087405]

Quetiapine Fumarate TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA207655
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-11-29

NDC 65862-874-60 [65862087460]

Quetiapine Fumarate TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA207655
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-11-29

NDC 65862-874-01 [65862087401]

Quetiapine Fumarate TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA207655
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-11-29

Drug Details

Active Ingredients

IngredientStrength
QUETIAPINE FUMARATE150 mg/1

OpenFDA Data

SPL SET ID:6562eb60-0d70-4909-bd07-88d5c9241516
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 721796
  • 853201
  • 721794
  • 895670
  • 721791
  • Pharmacological Class

    • Atypical Antipsychotic [EPC]

    Medicade Reported Pricing

    65862087460 QUETIAPINE ER 150 MG TABLET

    Pricing Unit: EA | Drug Type:

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

    NDCBrand NameGeneric Name
    0054-0220Quetiapine FumarateQuetiapine Fumarate
    0054-0221Quetiapine FumarateQuetiapine Fumarate
    0054-0222Quetiapine FumarateQuetiapine Fumarate
    0054-0223Quetiapine FumarateQuetiapine Fumarate
    0054-0229Quetiapine FumarateQuetiapine Fumarate
    0054-0230Quetiapine FumarateQuetiapine Fumarate
    67877-242Quetiapine FumarateQuetiapine Fumarate
    67877-249Quetiapine FumarateQuetiapine Fumarate
    67877-250Quetiapine FumarateQuetiapine Fumarate
    67877-246Quetiapine FumarateQuetiapine Fumarate
    67877-248Quetiapine FumarateQuetiapine Fumarate
    67877-245Quetiapine FumarateQuetiapine Fumarate
    67877-247Quetiapine FumarateQuetiapine Fumarate
    68001-183Quetiapine fumarateQuetiapine fumarate
    68001-182Quetiapine fumarateQuetiapine fumarate
    68001-184Quetiapine fumarateQuetiapine fumarate
    68001-180Quetiapine fumarateQuetiapine fumarate
    68001-185Quetiapine fumarateQuetiapine fumarate
    68001-181Quetiapine fumarateQuetiapine fumarate
    68071-1892Quetiapine FumarateQuetiapine Fumarate
    68180-450Quetiapine fumarateQuetiapine fumarate
    68180-447Quetiapine fumarateQuetiapine fumarate
    68180-448Quetiapine fumarateQuetiapine fumarate
    68151-5225Quetiapine FumarateQuetiapine Fumarate
    68180-614Quetiapine fumarateQuetiapine fumarate
    68180-613Quetiapine fumarateQuetiapine fumarate
    68180-615Quetiapine fumarateQuetiapine fumarate
    68180-616Quetiapine fumarateQuetiapine fumarate
    68180-445Quetiapine fumarateQuetiapine fumarate
    68180-446Quetiapine fumarateQuetiapine fumarate
    68180-612Quetiapine fumarateQuetiapine fumarate
    68180-449Quetiapine fumarateQuetiapine fumarate
    68788-7195Quetiapine fumarateQuetiapine fumarate
    68788-9487Quetiapine fumarateQuetiapine fumarate
    68788-9490Quetiapine FumarateQuetiapine Fumarate
    69189-0495Quetiapine FumarateQuetiapine Fumarate
    69189-0580Quetiapine FumarateQuetiapine Fumarate
    70518-0753quetiapine fumaratequetiapine fumarate
    70518-0767Quetiapine fumarateQuetiapine fumarate
    70518-0556Quetiapine fumarateQuetiapine fumarate
    70518-0638Quetiapine FumarateQuetiapine Fumarate
    70518-0594Quetiapine fumarateQuetiapine fumarate
    70518-0645Quetiapine FumarateQuetiapine Fumarate
    70518-0974Quetiapine FumarateQuetiapine Fumarate
    70518-1018Quetiapine FumarateQuetiapine Fumarate
    70518-1029quetiapine fumaratequetiapine fumarate
    70518-0975Quetiapine FumarateQuetiapine Fumarate
    70518-0989Quetiapine FumarateQuetiapine Fumarate
    70518-0723Quetiapine FumarateQuetiapine Fumarate
    70518-0988Quetiapine fumarateQuetiapine fumarate

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.