NDC 71205-026

Quetiapine

Quetiapine

Quetiapine is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Proficient Rx Lp. The primary component is Quetiapine Fumarate.

Product ID71205-026_0f113fcf-a38c-4838-8a08-3f1f14d313f9
NDC71205-026
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 NameProficient Rx LP
Substance NameQUETIAPINE FUMARATE
Active Ingredient Strength300 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 71205-026-03

3 TABLET, FILM COATED in 1 BOTTLE (71205-026-03)
Marketing Start Date2018-05-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71205-026-30 [71205002630]

Quetiapine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077745
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-05-01

NDC 71205-026-60 [71205002660]

Quetiapine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077745
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-05-01

NDC 71205-026-90 [71205002690]

Quetiapine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077745
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-05-01

NDC 71205-026-03 [71205002603]

Quetiapine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077745
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-05-01

Drug Details

Active Ingredients

IngredientStrength
QUETIAPINE FUMARATE300 mg/1

OpenFDA Data

SPL SET ID:dd6b6088-943e-413b-9886-88dd9c622be4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 312745

    • 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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