Bupropion hydrochloride

Product NDC
58657-712
11-digit product format
586570712
Labeler code
58657
Product ID
58657-712_edb47931-e2a7-4ee7-e053-2995a90a40b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Method Pharmaceuticals, LLC
Application
ANDA211020
Marketing category
ANDA
Marketing start
2019-01-28
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
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
58657-712-305865707123030 TABLET, EXTENDED RELEASE in 1 BOTTLE (58657-712-30) 2019-01-280000-00-00NoNoCurrent
58657-712-5058657071250500 TABLET, EXTENDED RELEASE in 1 BOTTLE (58657-712-50) 2019-01-280000-00-00NoNoCurrent
58657-712-905865707129090 TABLET, EXTENDED RELEASE in 1 BOTTLE (58657-712-90) 2019-01-280000-00-00NoNoCurrent