buPROpion Hydrochloride

Product NDC
52817-346
11-digit product format
528170346
Labeler code
52817
Product ID
52817-346_f0d4825a-95dd-48f8-e053-2a95a90aeeb0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
TruPharma LLC
Application
ANDA211200
Marketing category
ANDA
Marketing start
2022-01-27
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52817-346-50EA - Each52817-34672c0ad17-877e-4785-a6b6-90fe6146202912022-02-07
52817-346-90EA - Each52817-346da60ef82-3c61-43d9-a3c4-417aa66c0c3c12022-02-07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
52817-346-305281703463030 TABLET, EXTENDED RELEASE in 1 BOTTLE (52817-346-30) 2022-01-270000-00-00NoNoCurrent
52817-346-5052817034650500 TABLET, EXTENDED RELEASE in 1 BOTTLE (52817-346-50) 2022-01-270000-00-00NoNoCurrent
52817-346-905281703469090 TABLET, EXTENDED RELEASE in 1 BOTTLE (52817-346-90) 2022-01-270000-00-00NoNoCurrent