NDC 0615-7987

Quetiapine

Quetiapine

Quetiapine is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Ncs Healthcare Of Ky, Inc Dba Vangard Labs. The primary component is Quetiapine Fumarate.

Product ID0615-7987_087b49e9-6968-4472-8a97-fa2d71f8a001
NDC0615-7987
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 NameNCS HealthCare of KY, Inc dba Vangard Labs
Substance NameQUETIAPINE FUMARATE
Active Ingredient Strength50 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0615-7987-05

15 TABLET, FILM COATED in 1 BLISTER PACK (0615-7987-05)
Marketing Start Date2016-05-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0615-7987-05 [00615798705]

Quetiapine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA202152
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-05-06

NDC 0615-7987-39 [00615798739]

Quetiapine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA202152
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-05-06

NDC 0615-7987-30 [00615798730]

Quetiapine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA202152
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-05-13

Drug Details

Active Ingredients

IngredientStrength
QUETIAPINE FUMARATE50 mg/1

OpenFDA Data

SPL SET ID:bb5a14a3-0283-4eb2-88e4-8e53375394a2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 312743
  • 616487
  • 312744
  • 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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