Bupropion hydrochloride

Product NDC
59746-314
11-digit product format
597460314
Labeler code
59746
Product ID
59746-314_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
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
2020-12-31
Current FDA listing
Historical FDA.report record