NDC 10135-659

Quetiapine Extended Release

Quetiapine

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

Product ID10135-659_6fd3392c-0934-402e-8b1a-75b2b9ca9d95
NDC10135-659
Product TypeHuman Prescription Drug
Proprietary NameQuetiapine Extended Release
Generic NameQuetiapine
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2018-05-01
Marketing CategoryANDA / ANDA
Application NumberANDA209635
Labeler NameMarlex Pharmaceuticals Inc
Substance NameQUETIAPINE FUMARATE
Active Ingredient Strength400 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 10135-659-60

60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10135-659-60)
Marketing Start Date2018-05-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 10135-659-60 [10135065960]

Quetiapine Extended Release TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA209635
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-05-01
Inactivation Date2020-01-31
Reactivation Date2020-02-20

Drug Details

Active Ingredients

IngredientStrength
QUETIAPINE FUMARATE400 mg/1

OpenFDA Data

SPL SET ID:a70d857a-50d3-4e69-828c-a72fd6b98c99
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 721796
  • 721794
  • 895670
  • 721791
  • UPC Code
  • 0310135657605
  • 0310135658602
  • 0310135659609
  • 0310135656608
  • Pharmacological Class

    • Atypical Antipsychotic [EPC]

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

    NDCBrand NameGeneric Name
    70518-1744Quetiapine Extended ReleaseQuetiapine Extended Release
    70518-1823Quetiapine Extended ReleaseQuetiapine Extended Release
    71093-139Quetiapine Extended ReleaseQuetiapine Extended Release
    71093-136Quetiapine Extended ReleaseQuetiapine Extended Release
    71093-135Quetiapine Extended ReleaseQuetiapine Extended Release
    71093-138Quetiapine Extended ReleaseQuetiapine Extended Release
    71093-137Quetiapine Extended ReleaseQuetiapine Extended Release
    10135-657Quetiapine Extended ReleaseQuetiapine Extended Release
    10135-658Quetiapine Extended ReleaseQuetiapine Extended Release
    10135-659Quetiapine Extended ReleaseQuetiapine Extended Release
    10135-656Quetiapine Extended ReleaseQuetiapine Extended Release
    50228-382Quetiapine Extended ReleaseQuetiapine Extended Release
    50228-383Quetiapine Extended ReleaseQuetiapine Extended Release
    50228-380Quetiapine Extended ReleaseQuetiapine Extended Release
    50228-384Quetiapine Extended ReleaseQuetiapine Extended Release
    50228-381Quetiapine Extended ReleaseQuetiapine Extended Release
    0093-2063QuetiapineQuetiapine
    0093-8162QuetiapineQuetiapine
    0093-8163QuetiapineQuetiapine
    0093-8164QuetiapineQuetiapine
    0093-8165QuetiapineQuetiapine
    0093-8166QuetiapineQuetiapine
    0310-0271SEROQUELquetiapine

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