QUETIAPINE FUMARATE

Product NDC
50090-5442
11-digit product format
500905442
Labeler code
50090
Product ID
50090-5442_6a0bc8f8-d8f8-44e2-b714-ce0c0be32916
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
QUETIAPINE FUMARATE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090681
Marketing category
ANDA
Marketing start
2019-01-01
Marketing end
0000-00-00
Substance
QUETIAPINE FUMARATE
Active strength
300 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
2S3PL1B6UJQUETIAPINE FUMARATE111974-72-2QUETIAPINE FUMARATE

Packages

Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5442-05009054420060 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-5442-0) 2021-01-210000-00-00NoNoCurrent

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
QUETIAPINE FUMARATEA-S Medication Solutions2021-03-03HUMAN PRESCRIPTION DRUG LABEL1