NDC 68788-7412

Quetiapine

Quetiapine

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

Product ID68788-7412_3b275fd9-0087-42c3-9d51-316c108e72b1
NDC68788-7412
Product TypeHuman Prescription Drug
Proprietary NameQuetiapine
Generic NameQuetiapine
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2018-06-07
Marketing CategoryANDA / ANDA
Application NumberANDA202152
Labeler NamePreferred Pharmaceuticals Inc.
Substance NameQUETIAPINE FUMARATE
Active Ingredient Strength100 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 68788-7412-1

100 TABLET, FILM COATED in 1 BOTTLE (68788-7412-1)
Marketing Start Date2018-06-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68788-7412-9 [68788741209]

Quetiapine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA202152
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-06-07

NDC 68788-7412-6 [68788741206]

Quetiapine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA202152
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-06-07

NDC 68788-7412-8 [68788741208]

Quetiapine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA202152
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-06-07

NDC 68788-7412-3 [68788741203]

Quetiapine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA202152
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-06-07

NDC 68788-7412-1 [68788741201]

Quetiapine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA202152
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-06-07

Drug Details

Active Ingredients

IngredientStrength
QUETIAPINE FUMARATE100 mg/1

OpenFDA Data

SPL SET ID:2c2e852b-2894-4c37-b48f-53b8e9e65a02
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 312743
  • Pharmacological Class

    • Atypical Antipsychotic [EPC]
    • 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.