NDC 57297-449

Quetiapine fumarate

Quetiapine Fumarate

Quetiapine fumarate is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Lupin Limited. The primary component is Quetiapine Fumarate.

Product ID57297-449_28b08037-0fdb-4dd9-a3e4-e9bba5ca8948
NDC57297-449
Product TypeHuman Prescription Drug
Proprietary NameQuetiapine fumarate
Generic NameQuetiapine Fumarate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2012-03-27
Marketing CategoryANDA / ANDA
Application NumberANDA201109
Labeler NameLUPIN LIMITED
Substance NameQUETIAPINE FUMARATE
Active Ingredient Strength300 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 57297-449-02

500 TABLET in 1 BOTTLE (57297-449-02)
Marketing Start Date2012-03-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 57297-449-03 [57297044903]

Quetiapine fumarate TABLET
Marketing CategoryANDA
Application NumberANDA201109
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-03-27
Inactivation Date2020-01-31

NDC 57297-449-07 [57297044907]

Quetiapine fumarate TABLET
Marketing CategoryANDA
Application NumberANDA201109
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-03-27
Inactivation Date2020-01-31

NDC 57297-449-13 [57297044913]

Quetiapine fumarate TABLET
Marketing CategoryANDA
Application NumberANDA201109
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-03-27
Inactivation Date2020-01-31

NDC 57297-449-02 [57297044902]

Quetiapine fumarate TABLET
Marketing CategoryANDA
Application NumberANDA201109
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-03-27
Inactivation Date2020-01-31

NDC 57297-449-01 [57297044901]

Quetiapine fumarate TABLET
Marketing CategoryANDA
Application NumberANDA201109
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-03-27
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
QUETIAPINE FUMARATE300 mg/1

OpenFDA Data

SPL SET ID:b519b924-2348-46ac-b9a2-c9c198257ea4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 616487
  • 616483
  • 312743
  • 317174
  • 312745
  • 312744

    • 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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