NDC 13668-152

QUETIAPINE FUMARATE

Quetiapine Fumarate

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

Product ID13668-152_150ea789-0a04-4019-9231-9863b8807085
NDC13668-152
Product TypeHuman Prescription Drug
Proprietary NameQUETIAPINE FUMARATE
Generic NameQuetiapine Fumarate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2012-03-27
Marketing CategoryANDA / ANDA
Application NumberANDA200363
Labeler NameTORRENT PHARMACEUTICALS LIMITED
Substance NameQUETIAPINE FUMARATE
Active Ingredient Strength300 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 13668-152-01

100 TABLET in 1 BOTTLE (13668-152-01)
Marketing Start Date2012-03-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 13668-152-74 [13668015274]

QUETIAPINE FUMARATE TABLET
Marketing CategoryANDA
Application NumberANDA200363
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-03-27
Marketing End Date2012-03-27

NDC 13668-152-01 [13668015201]

QUETIAPINE FUMARATE TABLET
Marketing CategoryANDA
Application NumberANDA200363
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-03-27
Marketing End Date2012-03-27

NDC 13668-152-30 [13668015230]

QUETIAPINE FUMARATE TABLET
Marketing CategoryANDA
Application NumberANDA200363
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-03-27
Marketing End Date2012-03-27

NDC 13668-152-60 [13668015260]

QUETIAPINE FUMARATE TABLET
Marketing CategoryANDA
Application NumberANDA200363
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-03-27
Marketing End Date2012-03-27

NDC 13668-152-31 [13668015231]

QUETIAPINE FUMARATE TABLET
Marketing CategoryANDA
Application NumberANDA200363
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-03-27
Marketing End Date2012-03-27

NDC 13668-152-05 [13668015205]

QUETIAPINE FUMARATE TABLET
Marketing CategoryANDA
Application NumberANDA200363
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-03-27
Marketing End Date2012-03-27

Drug Details

Active Ingredients

IngredientStrength
QUETIAPINE FUMARATE300 mg/1

OpenFDA Data

SPL SET ID:47dc96cb-e586-44dd-a002-1b1d1bf48d3d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 616487
  • 616483
  • 312743
  • 317174
  • 312745
  • 312744
  • UPC Code
  • 0313668149050
  • 0313668148053
  • Pharmacological Class

    • 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

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