Quetiapine Fumarate

Product NDC

0310-8280

11-digit product format

003108280

Labeler code

0310

Product ID

0310-8280_c01bffdc-89ff-47a0-a3e1-1868c9002ee2

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Quetiapine fumarate

Dosage form

TABLET, FILM COATED, EXTENDED RELEASE

Route

ORAL

Labeler

AstraZeneca Pharmaceuticals LP

Application

NDA022047

Marketing category

NDA AUTHORIZED GENERIC

Marketing start

2017-05-01

Marketing end

2020-05-31

Substance

QUETIAPINE FUMARATE

Active strength

50 mg/1

Pharmacologic classes

Atypical Antipsychotic [EPC]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record