FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
50436-1570
11-digit product format
504361570
Labeler code
50436
Product ID
50436-1570_79eb179f-9391-444b-b4c3-ca3524c98192
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unit Dose Services
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
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
50436-1570-12021-01-29C16284748780-1ba0f9c33-2bcc-a910-e053-dadaa90a0b85These 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
50436-1570-1Bupropion Hydrochloride30 in 1 BOTTLETABLET, FILM COATED304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-1570BUPROPION HYDROCHLORIDE TABLET, FILM COATED [UNIT DOSE SERVICES]4Legacy NDC, 1 package rows20190921_234f83b2-2ab5-4ac1-966b-e300b68d2f2e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993687buPROPion HCl 100 MG Oral TabletPSN234f83b2-2ab5-4ac1-966b-e300b68d2f2e4
993691buPROPion HCl 75 MG Oral TabletPSN234f83b2-2ab5-4ac1-966b-e300b68d2f2e4
993687bupropion hydrochloride 100 MG Oral TabletSCD234f83b2-2ab5-4ac1-966b-e300b68d2f2e4
993691bupropion hydrochloride 75 MG Oral TabletSCD234f83b2-2ab5-4ac1-966b-e300b68d2f2e4
993691bupropion HCl 75 MG Oral TabletSY234f83b2-2ab5-4ac1-966b-e300b68d2f2e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-1570-15043615700130 in 1 BOTTLEHistorical