FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
67544-897
11-digit product format
675440897
Labeler code
67544
Product ID
67544-897_fab783ec-e767-4a9e-80d7-a2aa9e04b930
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA076143
Marketing category
ANDA
Marketing start
2006-01-17
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
2021-12-31
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
67544-897-532023-01-30C16284748780-1f386c64a-0da0-0266-e053-dadaa90a7c1aBUPROPION HYDROCHLORIDE TABLETS These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE TABLETS. BUPROPION HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1985
67544-897-602023-01-30C16284748780-1f386c64a-0da0-0266-e053-dadaa90a7c1aBUPROPION HYDROCHLORIDE TABLETS These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE TABLETS. BUPROPION HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1985
67544-897-802023-01-30C16284748780-1f386c64a-0da0-0266-e053-dadaa90a7c1aBUPROPION HYDROCHLORIDE TABLETS These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE TABLETS. BUPROPION HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1985
67544-897-832023-01-30C16284748780-1f386c64a-0da0-0266-e053-dadaa90a7c1aBUPROPION HYDROCHLORIDE TABLETS These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE TABLETS. BUPROPION HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1985

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67544-897-53Bupropion Hydrochloride60 in 1 BOTTLETABLET, FILM COATED601
67544-897-60Bupropion Hydrochloride90 in 1 BOTTLETABLET, FILM COATED901
67544-897-80Bupropion Hydrochloride180 in 1 BOTTLETABLET, FILM COATED1801
67544-897-83Bupropion Hydrochloride3600 in 1 BOTTLETABLET, FILM COATED36001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67544-897BUPROPION HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 4 package rows20200303_82b6e823-6b5d-4477-87c2-741cf4611015.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993687buPROPion HCl 100 MG Oral TabletPSN82b6e823-6b5d-4477-87c2-741cf46110151
993687bupropion hydrochloride 100 MG Oral TabletSCD82b6e823-6b5d-4477-87c2-741cf46110151

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67544-897-536754408975360 TABLET, FILM COATED in 1 BOTTLE (67544-897-53) 2019-12-120000-00-00NoNoCurrent
67544-897-606754408976090 TABLET, FILM COATED in 1 BOTTLE (67544-897-60) 2019-12-120000-00-00NoNoCurrent
67544-897-8067544089780180 TABLET, FILM COATED in 1 BOTTLE (67544-897-80) 2019-12-210000-00-00NoNoCurrent
67544-897-83675440897833600 TABLET, FILM COATED in 1 BOTTLE (67544-897-83) 2020-01-100000-00-00NoNoCurrent