Bupropion Hydrochloride

Product NDC
43353-575
11-digit product format
433530575
Labeler code
43353
Product ID
43353-575_c9fe3f15-c0b9-47e7-9930-4536b88ffaf9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA075491
Marketing category
ANDA
Marketing start
2010-02-01
Marketing end
0000-00-00
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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-575-53EA - Each43353-575bcd7455a-26ba-43d4-bb36-87a36953648612017-12-14
43353-575-60EA - Each43353-5754dd56e73-7ffe-4ce5-9cb8-640323db937012017-12-14
43353-575-70EA - Each43353-575a6766eef-476a-4b02-9499-ac00f38d83cc12017-12-14
43353-575-80EA - Each43353-575b2fb5a9d-f606-4bac-9bf6-0fa3b178cd4612017-12-14
43353-575-92EA - Each43353-5757c498c00-cc46-447d-905c-ce5dfac61bf412017-12-14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43353-575-534335305755360 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-575-53) 2010-02-030000-00-00NoNoCurrent
43353-575-604335305756090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-575-60) 2010-02-030000-00-00NoNoCurrent
43353-575-7043353057570120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-575-70) 2011-08-160000-00-00NoNoCurrent
43353-575-8043353057580180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-575-80) 2011-08-160000-00-00NoNoCurrent
43353-575-9243353057592270 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-575-92) 2011-08-160000-00-00NoNoCurrent