NDC 50228-384

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 Sciegen Pharmaceuticals, Inc. The primary component is Quetiapine Fumarate.

Product ID50228-384_3009ba5b-d2cb-4eb5-aaef-c72f2f6b3c09
NDC50228-384
Product TypeHuman Prescription Drug
Proprietary NameQuetiapine Extended Release
Generic NameQuetiapine
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2017-11-29
Marketing CategoryANDA / ANDA
Application NumberANDA209635
Labeler NameScieGen Pharmaceuticals, Inc
Substance NameQUETIAPINE FUMARATE
Active Ingredient Strength400 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 50228-384-05

500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50228-384-05)
Marketing Start Date2017-11-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50228-384-60 [50228038460]

Quetiapine Extended Release TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA209635
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-11-29

NDC 50228-384-05 [50228038405]

Quetiapine Extended Release TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA209635
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-11-29

NDC 50228-384-30 [50228038430]

Quetiapine Extended Release TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA209635
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-11-29

Drug Details

Active Ingredients

IngredientStrength
QUETIAPINE FUMARATE400 mg/1

OpenFDA Data

SPL SET ID:5e4a84b1-fb8c-44d0-8213-51e43d71db69
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 721796
  • 853201
  • 721794
  • 895670
  • 721791
    • UPC Code
  • 0350228383608
  • 0350228382601
  • 0350228384605
  • 0350228380607
  • 0350228381604

    • 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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