Bupropion Hydrochloride

Product NDC
43353-189
11-digit product format
433530189
Labeler code
43353
Product ID
43353-189_280a37d9-a4b4-4aef-95d8-10776c4dc31e
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
2005-06-22
Marketing end
0000-00-00
Substance
BUPROPION HYDROCHLORIDE
Active strength
200 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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-189-83Bupropion Hydrochloride3600 in 1 BOTTLETABLET, EXTENDED RELEASE36004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-189BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]4Legacy NDC, 1 package rows20191219_32ce3963-6ad7-4e5b-9364-4c3282bc921f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993536buPROPion HCl 200 MG 12HR Extended Release Oral TabletPSN32ce3963-6ad7-4e5b-9364-4c3282bc921f4
99353612 HR bupropion hydrochloride 200 MG Extended Release Oral TabletSCD32ce3963-6ad7-4e5b-9364-4c3282bc921f4
993536bupropion hydrochloride 200 MG 12 HR Extended Release Oral TabletSY32ce3963-6ad7-4e5b-9364-4c3282bc921f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43353-189-83433530189833600 TABLET, EXTENDED RELEASE in 1 BOTTLE (43353-189-83) 2016-06-200000-00-00NoNoCurrent