Bupropion Hydrochloride

Product NDC
67544-299
11-digit product format
675440299
Labeler code
67544
Product ID
67544-299_16d1151d-57e4-40ba-96a6-b5c0bc1f1d46
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA075932
Marketing category
ANDA
Marketing start
2004-03-22
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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4eceb285-f3c7-4092-a21a-4c9f3169f20cProduct name520260220
548ba7fd-fd0c-4a21-b2b0-d01bf93143b8Product name320240209
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
b8ee525f-67fb-39fb-91da-7e47ac54581dProduct name520200611
98e65af1-f5d0-75d5-c930-f8a4ce4c3284Product name920190211
e4d463bc-c674-43cb-be06-82786f310d01Product name120150326
0916dcfb-331f-89b1-8eac-6f7dc76d82daProduct name120140508
d7fc3d53-5a6c-de82-2808-1780f175f17eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67544-299-302023-01-30C16284748780-1f386c64a-31ac-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use BuPROPion HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR) safely and effectively. See full prescribing information for BuPROPion HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR) . BuPROPion HYDROCHLORIDE extended-release tablets (SR), for oral use . Initial U.S. Approval: 1985
67544-299-532023-01-30C16284748780-1f386c64a-31ac-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use BuPROPion HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR) safely and effectively. See full prescribing information for BuPROPion HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR) . BuPROPion HYDROCHLORIDE extended-release tablets (SR), for oral use . Initial U.S. Approval: 1985
67544-299-602023-01-30C16284748780-1f386c64a-31ac-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use BuPROPion HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR) safely and effectively. See full prescribing information for BuPROPion HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR) . BuPROPion HYDROCHLORIDE extended-release tablets (SR), for oral use . Initial U.S. Approval: 1985
67544-299-802023-01-30C16284748780-1f386c64a-31ac-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use BuPROPion HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR) safely and effectively. See full prescribing information for BuPROPion HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR) . BuPROPion HYDROCHLORIDE extended-release tablets (SR), for oral use . Initial U.S. Approval: 1985

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67544-299-30Bupropion Hydrochloride30 in 1 BOTTLETABLET, EXTENDED RELEASE302
67544-299-53Bupropion Hydrochloride60 in 1 BOTTLETABLET, EXTENDED RELEASE602
67544-299-60Bupropion Hydrochloride90 in 1 BOTTLETABLET, EXTENDED RELEASE902
67544-299-80Bupropion Hydrochloride180 in 1 BOTTLETABLET, EXTENDED RELEASE1802

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67544-299BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Legacy NDC, 4 package rows20191224_8cf8931a-0891-4adb-aeb6-1c91ed9b7de1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSN8cf8931a-0891-4adb-aeb6-1c91ed9b7de12
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD8cf8931a-0891-4adb-aeb6-1c91ed9b7de12
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSY8cf8931a-0891-4adb-aeb6-1c91ed9b7de12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67544-299-306754402993030 TABLET, EXTENDED RELEASE in 1 BOTTLE (67544-299-30) 2014-06-100000-00-00NoNoCurrent
67544-299-536754402995360 TABLET, EXTENDED RELEASE in 1 BOTTLE (67544-299-53) 2014-06-100000-00-00NoNoCurrent
67544-299-606754402996090 TABLET, EXTENDED RELEASE in 1 BOTTLE (67544-299-60) 2016-06-020000-00-00NoNoCurrent
67544-299-8067544029980180 TABLET, EXTENDED RELEASE in 1 BOTTLE (67544-299-80) 2014-06-130000-00-00NoNoCurrent