NDC 0781-5343

Quetiapine Fumarate

Quetiapine Fumarate

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

Product ID0781-5343_30f76a1c-c830-4cdb-b487-0f9ab806b9fb
NDC0781-5343
Product TypeHuman Prescription Drug
Proprietary NameQuetiapine Fumarate
Generic NameQuetiapine Fumarate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2013-04-05
Marketing CategoryANDA / ANDA
Application NumberANDA078679
Labeler NameSandoz Inc
Substance NameQUETIAPINE FUMARATE
Active Ingredient Strength25 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0781-5343-01

100 TABLET in 1 BOTTLE (0781-5343-01)
Marketing Start Date2013-04-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0781-5343-10 [00781534310]

Quetiapine Fumarate TABLET
Marketing CategoryANDA
Application NumberANDA078679
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-04-05

NDC 0781-5343-01 [00781534301]

Quetiapine Fumarate TABLET
Marketing CategoryANDA
Application NumberANDA078679
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-04-05

NDC 0781-5343-06 [00781534306]

Quetiapine Fumarate TABLET
Marketing CategoryANDA
Application NumberANDA078679
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-04-05

NDC 0781-5343-13 [00781534313]

Quetiapine Fumarate TABLET
Marketing CategoryANDA
Application NumberANDA078679
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-04-05

NDC 0781-5343-31 [00781534331]

Quetiapine Fumarate TABLET
Marketing CategoryANDA
Application NumberANDA078679
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-04-05

Drug Details

Active Ingredients

IngredientStrength
QUETIAPINE FUMARATE25 mg/1

OpenFDA Data

SPL SET ID:70871d87-4a85-420f-b4dd-176e1f8f3bc5
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 389201
  • 616487
  • 616483
  • 312743
  • 317174
  • 312745
  • 312744
  • UPC Code
  • 0307815346010
  • 0307815345310
  • 0307815347017
  • 0307815348014
  • 0307815344016
  • 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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