NDC 27808-188

Quetiapine Fumarate Extended-Release

Quetiapine Fumarate

Quetiapine Fumarate Extended-Release is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Tris Pharma Inc.. The primary component is Quetiapine Fumarate.

Product ID27808-188_d9f3913d-6b98-437f-b8c5-73a277a2638b
NDC27808-188
Product TypeHuman Prescription Drug
Proprietary NameQuetiapine Fumarate Extended-Release
Generic NameQuetiapine Fumarate
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2019-11-15
Marketing CategoryANDA / ANDA
Application NumberANDA202939
Labeler NameTris Pharma Inc.
Substance NameQUETIAPINE FUMARATE
Active Ingredient Strength300 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 27808-188-01

60 TABLET, EXTENDED RELEASE in 1 BOTTLE (27808-188-01)
Marketing Start Date2019-11-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 27808-188-01 [27808018801]

Quetiapine Fumarate Extended-Release TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA202939
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-11-15
Marketing End Date2020-04-15

Drug Details

Active Ingredients

IngredientStrength
QUETIAPINE FUMARATE300 mg/1

Pharmacological Class

  • Atypical Antipsychotic [EPC]

NDC Crossover Matching brand name "Quetiapine Fumarate Extended-Release" or generic name "Quetiapine Fumarate"

NDCBrand NameGeneric Name
0406-1180Quetiapine Fumarate Extended-ReleaseQuetiapine Fumarate Extended-Release
0406-1181Quetiapine Fumarate Extended-ReleaseQuetiapine Fumarate Extended-Release
0406-1183Quetiapine Fumarate Extended-ReleaseQuetiapine Fumarate Extended-Release
0406-1182Quetiapine Fumarate Extended-ReleaseQuetiapine Fumarate Extended-Release
0406-1184Quetiapine Fumarate Extended-ReleaseQuetiapine Fumarate Extended-Release
27808-187Quetiapine Fumarate Extended-ReleaseQuetiapine Fumarate Extended-Release
27808-189Quetiapine Fumarate Extended-ReleaseQuetiapine Fumarate Extended-Release
27808-186Quetiapine Fumarate Extended-ReleaseQuetiapine Fumarate Extended-Release
27808-188Quetiapine Fumarate Extended-ReleaseQuetiapine Fumarate Extended-Release
27808-185Quetiapine Fumarate Extended-ReleaseQuetiapine Fumarate Extended-Release
0054-0220Quetiapine FumarateQuetiapine Fumarate
0054-0221Quetiapine FumarateQuetiapine Fumarate
0054-0222Quetiapine FumarateQuetiapine Fumarate
0054-0223Quetiapine FumarateQuetiapine Fumarate
0054-0229Quetiapine FumarateQuetiapine Fumarate
0054-0230Quetiapine FumarateQuetiapine Fumarate
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