NDC 43547-523

QUETIAPINE

Quetiapine

QUETIAPINE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Solco Healthcare Us, Llc. The primary component is Quetiapine Fumarate.

Product ID43547-523_61b1230e-c0dc-46c6-a577-7d5dd2515eb7
NDC43547-523
Product TypeHuman Prescription Drug
Proprietary NameQUETIAPINE
Generic NameQuetiapine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2022-04-12
Marketing CategoryANDA /
Application NumberANDA206954
Labeler NameSolco Healthcare US, LLC
Substance NameQUETIAPINE FUMARATE
Active Ingredient Strength400 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 43547-523-10

100 TABLET in 1 BOTTLE (43547-523-10)
Marketing Start Date2022-04-12
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "QUETIAPINE" or generic name "Quetiapine"

NDCBrand NameGeneric Name
0093-2063QuetiapineQuetiapine
0093-8162QuetiapineQuetiapine
0093-8163QuetiapineQuetiapine
0093-8164QuetiapineQuetiapine
0093-8165QuetiapineQuetiapine
0093-8166QuetiapineQuetiapine
68071-2038QuetiapineQuetiapine
68071-4161QuetiapineQuetiapine
68788-7185QuetiapineQuetiapine
68788-7184QuetiapineQuetiapine
68788-7186QuetiapineQuetiapine
68788-7412QuetiapineQuetiapine
70518-0229QuetiapineQuetiapine
70518-0239QuetiapineQuetiapine
70518-0289QuetiapineQuetiapine
70518-0345QuetiapineQuetiapine
70518-0432QuetiapineQuetiapine
70518-0889QuetiapineQuetiapine
70518-0808QuetiapineQuetiapine
70518-0825QuetiapineQuetiapine
70518-0570QuetiapineQuetiapine
70518-0752QuetiapineQuetiapine
70518-1477QuetiapineQuetiapine
70518-1569QuetiapineQuetiapine
71205-026QuetiapineQuetiapine
71335-0432QuetiapineQuetiapine
0615-7987QuetiapineQuetiapine
0615-7988QuetiapineQuetiapine
0615-7986QuetiapineQuetiapine
0615-8119QuetiapineQuetiapine
16714-452QuetiapineQuetiapine
16729-145QuetiapineQuetiapine
16714-455QuetiapineQuetiapine
16729-147QuetiapineQuetiapine
16714-456QuetiapineQuetiapine
16714-453QuetiapineQuetiapine
16714-457QuetiapineQuetiapine
16729-146QuetiapineQuetiapine
16729-149QuetiapineQuetiapine
16714-454QuetiapineQuetiapine
16729-150QuetiapineQuetiapine
16729-148QuetiapineQuetiapine
33342-135QUETIAPINEQUETIAPINE
33342-137QUETIAPINEQUETIAPINE
33342-134QUETIAPINEQUETIAPINE
33342-136QUETIAPINEQUETIAPINE
50090-2831QuetiapineQuetiapine
50090-2307QuetiapineQuetiapine
50090-2690QuetiapineQuetiapine
50090-2830QuetiapineQuetiapine

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