Quetiapine fumarate

Product NDC
60760-763
11-digit product format
607600763
Labeler code
60760
Product ID
60760-763_36248794-6b87-3631-e063-6294a90ab54c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
quetiapine fumarate
Dosage form
TABLET
Route
ORAL
Labeler
ST. MARY'S MEDICAL PARK PHARMACY
Application
ANDA201109
Marketing category
ANDA
Marketing start
2012-03-27
Substance
QUETIAPINE FUMARATE
Active strength
200 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
60760-763-306076007633030 TABLET in 1 BOTTLE, PLASTIC (60760-763-30) 30 tablet2025-05-21NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Quetiapine fumarateST. MARY'S MEDICAL PARK PHARMACY2025-05-27HUMAN PRESCRIPTION DRUG LABEL1