NDC 16729-095

QUETIAPINE FUMARATE

Quetiapine Fumarate

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

Product ID16729-095_84ea872c-dcfb-1f50-e053-2991aa0a5871
NDC16729-095
Product TypeHuman Prescription Drug
Proprietary NameQUETIAPINE FUMARATE
Generic NameQuetiapine Fumarate
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2017-05-22
Marketing CategoryANDA / ANDA
Application NumberANDA090681
Labeler NameAccord Healthcare Inc.
Substance NameQUETIAPINE FUMARATE
Active Ingredient Strength200 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 16729-095-12

60 TABLET, EXTENDED RELEASE in 1 BOTTLE (16729-095-12)
Marketing Start Date2019-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 16729-095-12 [16729009512]

QUETIAPINE FUMARATE TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA090681
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-05-22

Drug Details

Active Ingredients

IngredientStrength
QUETIAPINE FUMARATE200 mg/1

OpenFDA Data

SPL SET ID:3ffe0294-3959-2755-e054-00144ff8d46c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 721796
  • 721794
  • 895670
  • 721791
  • Pharmacological Class

    • Atypical Antipsychotic [EPC]
    • Atypical Antipsychotic [EPC]

    Medicade Reported Pricing

    16729009512 QUETIAPINE ER 200 MG TABLET

    Pricing Unit: EA | Drug Type:

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

    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.