Bupropion Hydrochloride

Product NDC
50268-140
11-digit product format
502680140
Labeler code
50268
Product ID
50268-140_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
2018-11-21
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50268-140-132022-01-31C16284748780-1d6a99b39-b872-a426-e053-dadaa90af4c2b1ddb021-51ff-6b78-b2ba-9ff6bce3d00d
50268-140-132022-01-28C16284748780-1d6a99b39-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
50268-140-11EA - Each50268-1404f52f6f6-d8d6-4be7-a3fb-cc483d68b53412019-02-13
50268-140-13EA - Each50268-140509fdfe9-3928-4f82-a6d6-d6090b79998112019-02-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-140-135026801401330 BLISTER PACK in 1 BOX (50268-140-13) > 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (50268-140-11) 30 blister pack2018-11-210000-00-00NoNoCurrent