Quetiapine Fumarate

Product NDC

49884-805

11-digit product format

498840805

Labeler code

49884

Product ID

49884-805_440f6694-a119-4982-b5ee-fd7a00d0c77a

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Quetiapine fumarate

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

Labeler

Par Pharmaceutical Inc.

Application

NDA022047

Marketing category

NDA AUTHORIZED GENERIC

Marketing start

2016-11-01

Marketing end

2019-10-31

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