NDC 71093-135

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 Aci Healthcare Usa, Inc.. The primary component is Quetiapine Fumarate.

Product ID71093-135_25f9ecdc-2698-4fd8-b4a3-42f37bec8f5b
NDC71093-135
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 NameACI Healthcare USA, Inc.
Substance NameQUETIAPINE FUMARATE
Active Ingredient Strength50 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 71093-135-02

60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71093-135-02)
Marketing Start Date2019-01-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71093-135-02 [71093013502]

Quetiapine Extended Release TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA209635
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-01-30

Drug Details

Active Ingredients

IngredientStrength
QUETIAPINE FUMARATE50 mg/1

OpenFDA Data

SPL SET ID:07e4f3f4-42cb-4b22-bf8d-8c3279d26e97
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 721796
  • 853201
  • 721794
  • 895670
  • 721791
    • UPC Code
  • 0371093136021
  • 0371093138025
  • 0371093135024
  • 0371093137028

    • 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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