Guanfacine Hydrochloride

Product NDC

0378-1065

11-digit product format

003781065

Labeler code

0378

Product ID

0378-1065_9c685c1b-b62c-4bc9-b105-609fb0df7ef6

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

guanfacine

Dosage form

TABLET, FILM COATED, EXTENDED RELEASE

Route

ORAL

Labeler

Mylan Pharmaceuticals Inc.

Application

ANDA202578

Marketing category

ANDA

Marketing start

2015-06-02

Marketing end

2019-11-30

Substance

GUANFACINE HYDROCHLORIDE

Active strength

4 mg/1

Pharmacologic classes

Central alpha-2 Adrenergic Agonist [EPC],Adrenergic alpha2-Agonists [MoA]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record