Quetiapine

Product NDC
71205-401
11-digit product format
712050401
Labeler code
71205
Product ID
71205-401_fbe8f179-fe43-43a4-b592-a31f2ec6aede
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA202152
Marketing category
ANDA
Marketing start
2012-03-28
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
BGL0JSY5SIQUETIAPINE111974-69-7Quetiapine

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71205-401-307120504013030 TABLET, FILM COATED in 1 BOTTLE (71205-401-30) 2020-02-13NoNoHistorical
71205-401-607120504016060 TABLET, FILM COATED in 1 BOTTLE (71205-401-60) 2020-02-13NoNoHistorical
71205-401-907120504019090 TABLET, FILM COATED in 1 BOTTLE (71205-401-90) 2020-02-13NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
QuetiapineProficient Rx LP2022-11-01HUMAN PRESCRIPTION DRUG LABEL2