Quetiapine Fumarate

Product NDC

0615-7728

11-digit product format

006157728

Labeler code

0615

Product ID

0615-7728_7fe8a652-3689-4f34-857c-fedb58123b03

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Quetiapine Fumarate

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

NCS HealthCare of KY, Inc dba Vangard Labs

Application

ANDA077745

Marketing category

ANDA

Marketing start

2012-03-27

Marketing end

0000-00-00

Substance

QUETIAPINE FUMARATE

Active strength

400 mg/1

Pharmacologic classes

Atypical Antipsychotic [EPC]

NDC exclude flag

E

Listing certified through

2017-12-31

Current FDA listing

Historical FDA.report record