Quetiapine Fumarate

Product NDC
60760-764
11-digit product format
607600764
Labeler code
60760
Product ID
60760-764_3624c9e6-3300-a325-e063-6394a90ae610
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine Fumarate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
ST. MARY'S MEDICAL PARK PHARMACY
Application
ANDA204316
Marketing category
ANDA
Marketing start
2022-06-16
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 formatDescriptionMarketing startSampleExclude flagStatus
60760-764-306076007643030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-764-30) 2025-05-21NoNoHistorical

Related DailyMed Labels

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