NDC 67046-632

Quetiapine fumarate

Quetiapine Fumarate

Quetiapine fumarate is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Contract Pharmacy Services-pa. The primary component is Quetiapine Fumarate.

Product ID67046-632_5abd1db3-4f3b-2359-e053-2a91aa0a1a43
NDC67046-632
Product TypeHuman Prescription Drug
Proprietary NameQuetiapine fumarate
Generic NameQuetiapine Fumarate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2017-10-04
Marketing CategoryANDA / ANDA
Application NumberANDA201109
Labeler NameContract Pharmacy Services-PA
Substance NameQUETIAPINE FUMARATE
Active Ingredient Strength100 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 67046-632-07

7 TABLET in 1 BLISTER PACK (67046-632-07)
Marketing Start Date2017-10-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67046-632-07 [67046063207]

Quetiapine fumarate TABLET
Marketing CategoryANDA
Application NumberANDA201109
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-10-04

NDC 67046-632-21 [67046063221]

Quetiapine fumarate TABLET
Marketing CategoryANDA
Application NumberANDA201109
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-10-04

NDC 67046-632-20 [67046063220]

Quetiapine fumarate TABLET
Marketing CategoryANDA
Application NumberANDA201109
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-10-04

NDC 67046-632-60 [67046063260]

Quetiapine fumarate TABLET
Marketing CategoryANDA
Application NumberANDA201109
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-10-04

NDC 67046-632-30 [67046063230]

Quetiapine fumarate TABLET
Marketing CategoryANDA
Application NumberANDA201109
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-10-04

NDC 67046-632-28 [67046063228]

Quetiapine fumarate TABLET
Marketing CategoryANDA
Application NumberANDA201109
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-10-04

NDC 67046-632-14 [67046063214]

Quetiapine fumarate TABLET
Marketing CategoryANDA
Application NumberANDA201109
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-10-04

NDC 67046-632-15 [67046063215]

Quetiapine fumarate TABLET
Marketing CategoryANDA
Application NumberANDA201109
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-10-04

Drug Details

Active Ingredients

IngredientStrength
QUETIAPINE FUMARATE100 mg/1

OpenFDA Data

SPL SET ID:5abdd41c-cfe1-d17e-e053-2a91aa0ab9ed
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 312743
  • UPC Code
  • 0368180447016
  • 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.