NDC 69948-003

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 Alignscience Pharma Inc.. The primary component is Quetiapine Fumarate.

Product ID69948-003_7366858f-2734-4214-a5ba-66307182fd62
NDC69948-003
Product TypeHuman Prescription Drug
Proprietary NameQuetiapine Extended-Release
Generic NameQuetiapine
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2020-03-31
Marketing CategoryANDA / ANDA
Application NumberANDA209497
Labeler NameAlignScience Pharma Inc.
Substance NameQUETIAPINE FUMARATE
Active Ingredient Strength200 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 69948-003-03

60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69948-003-03)
Marketing Start Date2019-03-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69948-003-03 [69948000303]

Quetiapine Extended-Release TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA209497
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-03-31

NDC 69948-003-11 [69948000311]

Quetiapine Extended-Release TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA209497
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-03-31

Drug Details

Active Ingredients

IngredientStrength
QUETIAPINE FUMARATE200 mg/1

OpenFDA Data

SPL SET ID:db3ba268-21a2-4988-b5c1-353741bcaee5
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 895670
  • 721791
  • UPC Code
  • 0369948002119
  • 0369948002034
  • 0369948003116
  • 0369948003031
  • Pharmacological Class

    • Atypical Antipsychotic [EPC]

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

    NDCBrand NameGeneric Name
    69948-002Quetiapine Extended-ReleaseQuetiapine Extended-Release
    69948-003Quetiapine Extended-ReleaseQuetiapine Extended-Release
    0093-2063QuetiapineQuetiapine
    0093-8162QuetiapineQuetiapine
    0093-8163QuetiapineQuetiapine
    0093-8164QuetiapineQuetiapine
    0093-8165QuetiapineQuetiapine
    0093-8166QuetiapineQuetiapine
    0310-0271SEROQUELquetiapine

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