Bupropion Hydrochloride

Product NDC

0378-2009

11-digit product format

003782009

Labeler code

0378

Product ID

0378-2009_116e58a5-3927-4360-b0be-bf08fc47c5d1

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

bupropion hydrochloride

Dosage form

TABLET, FILM COATED, EXTENDED RELEASE

Route

ORAL

Labeler

Mylan Pharmaceuticals Inc.

Application

ANDA090942

Marketing category

ANDA

Marketing start

2010-09-28

Marketing end

2019-11-30

Substance

BUPROPION HYDROCHLORIDE

Active strength

300 mg/1

Pharmacologic classes

Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record