Quetiapine Fumarate

Product NDC
71335-2333
11-digit product format
713352333
Labeler code
71335
Product ID
71335-2333_ad2422ca-1603-44ff-b245-8ecc515c20c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine Fumarate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA091388
Marketing category
ANDA
Marketing start
2012-03-27
Substance
QUETIAPINE FUMARATE
Active strength
100 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
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
71335-2333-171335233301100 TABLET, FILM COATED in 1 BOTTLE (71335-2333-1) 2024-07-16NoNoHistorical
71335-2333-27133523330230 TABLET, FILM COATED in 1 BOTTLE (71335-2333-2) 2024-01-25NoNoHistorical
71335-2333-371335233303120 TABLET, FILM COATED in 1 BOTTLE (71335-2333-3) 2024-07-16NoNoHistorical
71335-2333-47133523330460 TABLET, FILM COATED in 1 BOTTLE (71335-2333-4) 2024-07-16NoNoHistorical
71335-2333-57133523330590 TABLET, FILM COATED in 1 BOTTLE (71335-2333-5) 2024-07-16NoNoHistorical
71335-2333-67133523330615 TABLET, FILM COATED in 1 BOTTLE (71335-2333-6) 2024-07-16NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Quetiapine FumarateBryant Ranch Prepack2026-05-15HUMAN PRESCRIPTION DRUG LABEL102