NDC 70518-2547

Quetiapine fumarate

Quetiapine Fumarate

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

Product ID70518-2547_9c9df3b7-4fe0-f0df-e053-2995a90a8f06
NDC70518-2547
Product TypeHuman Prescription Drug
Proprietary NameQuetiapine fumarate
Generic NameQuetiapine Fumarate
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2020-01-19
Marketing CategoryANDA / ANDA
Application NumberANDA203359
Labeler NameREMEDYREPACK INC.
Substance NameQUETIAPINE FUMARATE
Active Ingredient Strength200 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 70518-2547-0

30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2547-0)
Marketing Start Date2020-01-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-2547-1 [70518254701]

Quetiapine fumarate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA203359
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-01-23

NDC 70518-2547-0 [70518254700]

Quetiapine fumarate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA203359
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-01-19

Drug Details

Active Ingredients

IngredientStrength
QUETIAPINE FUMARATE200 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.