NDC 71335-1462

Quetiapine Fumarate

Quetiapine Fumarate

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

Product ID71335-1462_19dad4f3-0f38-4ceb-bae0-7b9784e844dc
NDC71335-1462
Product TypeHuman Prescription Drug
Proprietary NameQuetiapine Fumarate
Generic NameQuetiapine Fumarate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2013-03-01
Marketing CategoryANDA / ANDA
Application NumberANDA201504
Labeler NameBryant Ranch Prepack
Substance NameQUETIAPINE FUMARATE
Active Ingredient Strength100 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 71335-1462-1

100 TABLET in 1 BOTTLE (71335-1462-1)
Marketing Start Date2022-09-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71335-1462-3 [71335146203]

Quetiapine Fumarate TABLET
Marketing CategoryANDA
Application NumberANDA201504
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-05-13

NDC 71335-1462-6 [71335146206]

Quetiapine Fumarate TABLET
Marketing CategoryANDA
Application NumberANDA201504
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-05-13

NDC 71335-1462-5 [71335146205]

Quetiapine Fumarate TABLET
Marketing CategoryANDA
Application NumberANDA201504
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-05-13

NDC 71335-1462-4 [71335146204]

Quetiapine Fumarate TABLET
Marketing CategoryANDA
Application NumberANDA201504
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-05-13

NDC 71335-1462-2 [71335146202]

Quetiapine Fumarate TABLET
Marketing CategoryANDA
Application NumberANDA201504
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-05-13

NDC 71335-1462-1 [71335146201]

Quetiapine Fumarate TABLET
Marketing CategoryANDA
Application NumberANDA201504
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-05-13

Drug Details

Active Ingredients

IngredientStrength
QUETIAPINE FUMARATE100 mg/1

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.