Quetiapine Fumarate

Product NDC
71205-826
11-digit product format
712050826
Labeler code
71205
Product ID
71205-826_85f973e0-93e6-4856-9266-62136acb2532
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine Fumarate
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA201504
Marketing category
ANDA
Marketing start
2013-03-01
Substance
QUETIAPINE FUMARATE
Active strength
25 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

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

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71205-826-307120508263030 TABLET in 1 BOTTLE (71205-826-30) 30 tablet2023-08-11NoNoHistorical
71205-826-607120508266060 TABLET in 1 BOTTLE (71205-826-60) 60 tablet2023-08-11NoNoHistorical
71205-826-907120508269090 TABLET in 1 BOTTLE (71205-826-90) 90 tablet2023-08-11NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Quetiapine FumarateProficient Rx LP2023-08-01HUMAN PRESCRIPTION DRUG LABEL1