Quetiapine Fumarate

Product NDC

70518-0646

11-digit product format

705180646

Labeler code

70518

Product ID

70518-0646_883fc875-b2b2-7999-e053-2a95a90aed44

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Quetiapine fumarate

Dosage form

TABLET, FILM COATED, EXTENDED RELEASE

Route

ORAL

Labeler

REMEDYREPACK INC.

Application

NDA022047

Marketing category

NDA AUTHORIZED GENERIC

Marketing start

2017-07-28

Marketing end

0000-00-00

Substance

QUETIAPINE FUMARATE

Active strength

200 mg/1

Pharmacologic classes

Atypical Antipsychotic [EPC]

NDC exclude flag

No

Listing certified through

2020-12-31

Current FDA listing

Historical FDA.report record