Bupropion hydrochloride

Product NDC

59746-758

11-digit product format

597460758

Labeler code

59746

Product ID

59746-758_719cb70d-ca1a-42a2-b12f-689485c5cf2f

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Bupropion hydrochloride extended-release tablets (XL)

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

Labeler

Jubilant Cadista Pharmaceuticals Inc.

Application

ANDA207459

Marketing category

ANDA

Marketing start

2017-06-30

Marketing end

0000-00-00

Substance

BUPROPION HYDROCHLORIDE

Active strength

150 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

2020-12-31

Current FDA listing

Historical FDA.report record