Bupropion Hydrochloride

Product NDC
50268-141
11-digit product format
502680141
Labeler code
50268
Product ID
50268-141_d5ce8ebd-372c-3da7-e053-2a95a90a0997
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion Hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
AvPAK
Application
ANDA077284
Marketing category
ANDA
Marketing start
2016-10-14
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50268-141-152022-01-31C16284748780-1d6a99b39-b872-a426-e053-dadaa90af4c2b1ddb021-51ff-6b78-b2ba-9ff6bce3d00d
50268-141-152022-01-28C16284748780-1d6a99b39-b872-a426-e053-dadaa90af4c2b1ddb021-51ff-6b78-b2ba-9ff6bce3d00d

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-141-11EA - Each50268-141dbf1f8a3-c6a8-4a48-ac0a-0ecbeda893d412016-12-07
50268-141-15EA - Each50268-141216690b4-38e8-4884-b921-2324c3cd7e9c12016-12-07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-141-155026801411550 BLISTER PACK in 1 BOX (50268-141-15) > 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (50268-141-11) 50 blister pack2016-10-140000-00-00NoNoCurrent