NDC 47335-906

Quetiapine fumarate

Quetiapine Fumarate

Quetiapine fumarate is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc.. The primary component is Quetiapine Fumarate.

Product ID47335-906_39d4d657-6952-4baf-8826-8bde5e0326cd
NDC47335-906
Product TypeHuman Prescription Drug
Proprietary NameQuetiapine fumarate
Generic NameQuetiapine Fumarate
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2012-03-28
Marketing CategoryANDA / ANDA
Application NumberANDA201190
Labeler NameSun Pharmaceutical Industries, Inc.
Substance NameQUETIAPINE FUMARATE
Active Ingredient Strength300 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 47335-906-18

1000 TABLET, FILM COATED in 1 BOTTLE (47335-906-18)
Marketing Start Date2012-03-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 47335-906-83 [47335090683]

Quetiapine fumarate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA201190
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-03-28

NDC 47335-906-61 [47335090661]

Quetiapine fumarate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA201190
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-03-28

NDC 47335-906-88 [47335090688]

Quetiapine fumarate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA201190
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-03-28

NDC 47335-906-18 [47335090618]

Quetiapine fumarate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA201190
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-03-28

NDC 47335-906-86 [47335090686]

Quetiapine fumarate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA201190
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-03-28

Drug Details

Active Ingredients

IngredientStrength
QUETIAPINE FUMARATE300 mg/1

OpenFDA Data

SPL SET ID:ffe52b98-9872-48c1-90fd-8fcd37c3432f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 616487
  • 616483
  • 312743
  • 317174
  • 312745
  • 312744
  • UPC Code
  • 0347335906837
  • 0347335902839
  • 0347335907834
  • 0347335905830
  • Pharmacological Class

    • Atypical Antipsychotic [EPC]

    Medicade Reported Pricing

    47335090688 QUETIAPINE FUMARATE 300 MG TAB

    Pricing Unit: EA | Drug Type:

    47335090686 QUETIAPINE FUMARATE 300 MG TAB

    Pricing Unit: EA | Drug Type:

    47335090618 QUETIAPINE FUMARATE 300 MG TAB

    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.