NDC 33342-137

QUETIAPINE

Quetiapine

QUETIAPINE is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Macleods Pharmaceuticals Limited. The primary component is Quetiapine Fumarate.

Product ID33342-137_0f3eef06-3012-4e5a-b104-d75a49acccce
NDC33342-137
Product TypeHuman Prescription Drug
Proprietary NameQUETIAPINE
Generic NameQuetiapine
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2017-11-01
Marketing CategoryANDA / ANDA
Application NumberANDA204253
Labeler NameMacleods Pharmaceuticals Limited
Substance NameQUETIAPINE FUMARATE
Active Ingredient Strength400 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 33342-137-09

60 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-137-09)
Marketing Start Date2017-11-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 33342-137-15 [33342013715]

QUETIAPINE TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA204253
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-11-01

NDC 33342-137-09 [33342013709]

QUETIAPINE TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA204253
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-11-01

Drug Details

Active Ingredients

IngredientStrength
QUETIAPINE FUMARATE400 mg/1

OpenFDA Data

SPL SET ID:d699b8c7-8a1c-44ed-85d8-c821a9c8c848
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 721796
  • 721794
  • 895670
  • 721791
  • UPC Code
  • 0333342137098
  • 0333342136091
  • 0333342135155
  • 0333342137159
  • Pharmacological Class

    • Atypical Antipsychotic [EPC]

    Medicade Reported Pricing

    33342013709 QUETIAPINE ER 400 MG TABLET

    Pricing Unit: EA | Drug Type: