NDC 59746-348

Quetiapine fumarate

Quetiapine Fumarate

Quetiapine fumarate is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Jubilant Cadista Pharmaceuticals Inc.. The primary component is Quetiapine Fumarate.

Product ID59746-348_d7460263-06fd-437d-a6df-dc0f3a613f67
NDC59746-348
Product TypeHuman Prescription Drug
Proprietary NameQuetiapine fumarate
Generic NameQuetiapine Fumarate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2013-11-27
Marketing CategoryANDA / ANDA
Application NumberANDA203150
Labeler NameJubilant Cadista Pharmaceuticals Inc.
Substance NameQUETIAPINE FUMARATE
Active Ingredient Strength25 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 59746-348-01

100 TABLET in 1 BOTTLE (59746-348-01)
Marketing Start Date2013-11-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 59746-348-03 [59746034803]

Quetiapine fumarate TABLET
Marketing CategoryANDA
Application NumberANDA203150
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-11-27

NDC 59746-348-01 [59746034801]

Quetiapine fumarate TABLET
Marketing CategoryANDA
Application NumberANDA203150
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-11-27

NDC 59746-348-60 [59746034860]

Quetiapine fumarate TABLET
Marketing CategoryANDA
Application NumberANDA203150
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-11-27

NDC 59746-348-10 [59746034810]

Quetiapine fumarate TABLET
Marketing CategoryANDA
Application NumberANDA203150
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-11-27

Drug Details

Active Ingredients

IngredientStrength
QUETIAPINE FUMARATE25 mg/1

OpenFDA Data

SPL SET ID:904f80af-44b6-d964-1680-ac9e6b61327b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 312744
  • UPC Code
  • 0359746348601
  • Pharmacological Class

    • Atypical Antipsychotic [EPC]
    • Atypical Antipsychotic [EPC]

    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.