Quetiapine

Product NDC
71205-402
11-digit product format
712050402
Labeler code
71205
Product ID
71205-402_6258bbaf-4ac0-4621-b95e-e6b032aa0518
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA077745
Marketing category
ANDA
Marketing start
2012-03-27
Substance
QUETIAPINE FUMARATE
Active strength
400 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
BGL0JSY5SIQUETIAPINE111974-69-7Quetiapine

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71205-402-307120504023030 TABLET, FILM COATED in 1 BOTTLE (71205-402-30) 2020-02-13NoNoHistorical
71205-402-607120504026060 TABLET, FILM COATED in 1 BOTTLE (71205-402-60) 2020-02-13NoNoHistorical
71205-402-907120504029090 TABLET, FILM COATED in 1 BOTTLE (71205-402-90) 2020-02-13NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
QuetiapineProficient Rx LP2020-02-01HUMAN PRESCRIPTION DRUG LABEL1