NDC 50742-639

Quetiapine Fumarate

Quetiapine Fumarate

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

Product ID50742-639_addc6221-3d67-4f93-88e0-b8054c14ace9
NDC50742-639
Product TypeHuman Prescription Drug
Proprietary NameQuetiapine Fumarate
Generic NameQuetiapine Fumarate
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2017-08-31
Marketing CategoryANDA / ANDA
Application NumberANDA208947
Labeler NameIngenus Pharmaceuticals, LLC
Substance NameQUETIAPINE FUMARATE
Active Ingredient Strength400 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 50742-639-10

1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-639-10)
Marketing Start Date2017-08-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50742-639-10 [50742063910]

Quetiapine Fumarate TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA208947
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-08-31

NDC 50742-639-90 [50742063990]

Quetiapine Fumarate TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA208947
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-08-31

NDC 50742-639-60 [50742063960]

Quetiapine Fumarate TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA208947
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-08-31

NDC 50742-639-30 [50742063930]

Quetiapine Fumarate TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA208947
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-08-31

Drug Details

Active Ingredients

IngredientStrength
QUETIAPINE FUMARATE400 mg/1

OpenFDA Data

SPL SET ID:8923c441-c9aa-4b30-89d7-dbaaa7f66656
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 721796
  • 853201
  • 721794
  • 895670
  • 721791
    • UPC Code
  • 0350742635603

    • Pharmacological Class

    • Atypical Antipsychotic [EPC]

    Medicade Reported Pricing

    50742063960 QUETIAPINE ER 400 MG TABLET

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Quetiapine Fumarate" or generic name "Quetiapine Fumarate"

    NDCBrand NameGeneric Name
    0054-0220Quetiapine FumarateQuetiapine Fumarate
    0054-0221Quetiapine FumarateQuetiapine Fumarate
    0054-0222Quetiapine FumarateQuetiapine Fumarate
    0054-0223Quetiapine FumarateQuetiapine Fumarate
    0054-0229Quetiapine FumarateQuetiapine Fumarate
    0054-0230Quetiapine FumarateQuetiapine Fumarate
    67877-242Quetiapine FumarateQuetiapine Fumarate
    67877-249Quetiapine FumarateQuetiapine Fumarate
    67877-250Quetiapine FumarateQuetiapine Fumarate
    67877-246Quetiapine FumarateQuetiapine Fumarate
    67877-248Quetiapine FumarateQuetiapine Fumarate
    67877-245Quetiapine FumarateQuetiapine Fumarate
    67877-247Quetiapine FumarateQuetiapine Fumarate
    68001-183Quetiapine fumarateQuetiapine fumarate
    68001-182Quetiapine fumarateQuetiapine fumarate
    68001-184Quetiapine fumarateQuetiapine fumarate
    68001-180Quetiapine fumarateQuetiapine fumarate
    68001-185Quetiapine fumarateQuetiapine fumarate
    68001-181Quetiapine fumarateQuetiapine fumarate
    68071-1892Quetiapine FumarateQuetiapine Fumarate
    68180-450Quetiapine fumarateQuetiapine fumarate
    68180-447Quetiapine fumarateQuetiapine fumarate
    68180-448Quetiapine fumarateQuetiapine fumarate
    68151-5225Quetiapine FumarateQuetiapine Fumarate
    68180-614Quetiapine fumarateQuetiapine fumarate
    68180-613Quetiapine fumarateQuetiapine fumarate
    68180-615Quetiapine fumarateQuetiapine fumarate
    68180-616Quetiapine fumarateQuetiapine fumarate
    68180-445Quetiapine fumarateQuetiapine fumarate
    68180-446Quetiapine fumarateQuetiapine fumarate
    68180-612Quetiapine fumarateQuetiapine fumarate
    68180-449Quetiapine fumarateQuetiapine fumarate
    68788-7195Quetiapine fumarateQuetiapine fumarate
    68788-9487Quetiapine fumarateQuetiapine fumarate
    68788-9490Quetiapine FumarateQuetiapine Fumarate
    69189-0495Quetiapine FumarateQuetiapine Fumarate
    69189-0580Quetiapine FumarateQuetiapine Fumarate
    70518-0753quetiapine fumaratequetiapine fumarate
    70518-0767Quetiapine fumarateQuetiapine fumarate
    70518-0556Quetiapine fumarateQuetiapine fumarate
    70518-0638Quetiapine FumarateQuetiapine Fumarate
    70518-0594Quetiapine fumarateQuetiapine fumarate
    70518-0645Quetiapine FumarateQuetiapine Fumarate
    70518-0974Quetiapine FumarateQuetiapine Fumarate
    70518-1018Quetiapine FumarateQuetiapine Fumarate
    70518-1029quetiapine fumaratequetiapine fumarate
    70518-0975Quetiapine FumarateQuetiapine Fumarate
    70518-0989Quetiapine FumarateQuetiapine Fumarate
    70518-0723Quetiapine FumarateQuetiapine Fumarate
    70518-0988Quetiapine fumarateQuetiapine fumarate
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.