Bupropion hydrochloride

Product NDC

0378-3411

11-digit product format

003783411

Labeler code

0378

Product ID

0378-3411_ba049508-c8db-4a58-985c-40e4e15b30b0

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Bupropion hydrochloride

Dosage form

TABLET, FILM COATED, EXTENDED RELEASE

Route

ORAL

Labeler

Mylan Pharmaceuticals Inc.

Application

ANDA090325

Marketing category

ANDA

Marketing start

2010-04-09

Marketing end

2019-12-31

Substance

BUPROPION HYDROCHLORIDE

Active strength

100 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