NDC 68071-2038

Quetiapine

Quetiapine

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

Product ID68071-2038_63262a47-d38d-ff7f-e053-2a91aa0af278
NDC68071-2038
Product TypeHuman Prescription Drug
Proprietary NameQuetiapine
Generic NameQuetiapine
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2012-03-28
Marketing CategoryANDA / ANDA
Application NumberANDA202152
Labeler NameNuCare Pharmaceuticals,Inc.
Substance NameQUETIAPINE FUMARATE
Active Ingredient Strength50 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 68071-2038-3

30 TABLET, FILM COATED in 1 BOTTLE (68071-2038-3)
Marketing Start Date2018-01-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68071-2038-3 [68071203803]

Quetiapine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA202152
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-01-19
Marketing End Date2019-12-31
Inactivation Date2020-01-31
Reactivation Date2020-04-14

Drug Details

Active Ingredients

IngredientStrength
QUETIAPINE FUMARATE50 mg/1

OpenFDA Data

SPL SET ID:63262a47-d38c-ff7f-e053-2a91aa0af278
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 616487
  • 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

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