NDC 0093-8165

Quetiapine

Quetiapine

Quetiapine is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Teva Pharmaceuticals Usa, Inc.. The primary component is Quetiapine Fumarate.

Product ID0093-8165_07ad3467-87bf-42bb-aad0-5dc5ccad7fd9
NDC0093-8165
Product TypeHuman Prescription Drug
Proprietary NameQuetiapine
Generic NameQuetiapine
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2012-03-27
Marketing CategoryANDA / ANDA
Application NumberANDA077745
Labeler NameTeva Pharmaceuticals USA, Inc.
Substance NameQUETIAPINE FUMARATE
Active Ingredient Strength400 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0093-8165-01

100 TABLET, FILM COATED in 1 BOTTLE (0093-8165-01)
Marketing Start Date2012-03-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0093-8165-10 [00093816510]

Quetiapine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077745
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-03-27
Marketing End Date2018-06-30

NDC 0093-8165-01 [00093816501]

Quetiapine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077745
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-03-27

Drug Details

Active Ingredients

IngredientStrength
QUETIAPINE FUMARATE400 mg/1

OpenFDA Data

SPL SET ID:c1d4ef59-bf58-44fe-9b46-1af42e2f7f8b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 616487
  • 616483
  • 312743
  • 317174
  • 312745
  • 312744
    • UPC Code
  • 0300932063013
  • 0300938164011
  • 0300938163014
  • 0300938166015
  • 0300938165018
  • 0300938162017

    • Pharmacological Class

    • Atypical Antipsychotic [EPC]

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

    NDCBrand NameGeneric Name
    0093-2063QuetiapineQuetiapine
    0093-8162QuetiapineQuetiapine
    0093-8163QuetiapineQuetiapine
    0093-8164QuetiapineQuetiapine
    0093-8165QuetiapineQuetiapine
    0093-8166QuetiapineQuetiapine
    68071-2038QuetiapineQuetiapine
    68071-4161QuetiapineQuetiapine
    68788-7185QuetiapineQuetiapine
    68788-7184QuetiapineQuetiapine
    68788-7186QuetiapineQuetiapine
    68788-7412QuetiapineQuetiapine
    70518-0229QuetiapineQuetiapine
    70518-0239QuetiapineQuetiapine
    70518-0289QuetiapineQuetiapine
    70518-0345QuetiapineQuetiapine
    70518-0432QuetiapineQuetiapine
    70518-0889QuetiapineQuetiapine
    70518-0808QuetiapineQuetiapine
    70518-0825QuetiapineQuetiapine
    70518-0570QuetiapineQuetiapine
    70518-0752QuetiapineQuetiapine
    70518-1477QuetiapineQuetiapine
    70518-1569QuetiapineQuetiapine
    71205-026QuetiapineQuetiapine
    71335-0432QuetiapineQuetiapine
    0615-7987QuetiapineQuetiapine
    0615-7988QuetiapineQuetiapine
    0615-7986QuetiapineQuetiapine
    0615-8119QuetiapineQuetiapine
    16714-452QuetiapineQuetiapine
    16729-145QuetiapineQuetiapine
    16714-455QuetiapineQuetiapine
    16729-147QuetiapineQuetiapine
    16714-456QuetiapineQuetiapine
    16714-453QuetiapineQuetiapine
    16714-457QuetiapineQuetiapine
    16729-146QuetiapineQuetiapine
    16729-149QuetiapineQuetiapine
    16714-454QuetiapineQuetiapine
    16729-150QuetiapineQuetiapine
    16729-148QuetiapineQuetiapine
    33342-135QUETIAPINEQUETIAPINE
    33342-137QUETIAPINEQUETIAPINE
    33342-134QUETIAPINEQUETIAPINE
    33342-136QUETIAPINEQUETIAPINE
    50090-2831QuetiapineQuetiapine
    50090-2307QuetiapineQuetiapine
    50090-2690QuetiapineQuetiapine
    50090-2830QuetiapineQuetiapine
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