FDA.reportPublic FDA data

bupropion

Product NDC
50436-0289
11-digit product format
504360289
Labeler code
50436
Product ID
50436-0289_cec7d664-178c-4ef1-87d8-8eeaf782b9d9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA202304
Marketing category
ANDA
Marketing start
2014-11-01
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
50436-0289-12021-01-29C16284748780-1ba0f9c33-5787-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use Bupropion Hydrochloride Extended-release (SR) tablets safely and effectively. See full prescribing information for Bupropion Hydrochloride Extended-release (SR) tablets. BUPROPION hydrochloride extended-release tablets USP (SR) for oral use Initial U.S. Approval: 1985
50436-0289-22021-01-29C16284748780-1ba0f9c33-5787-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use Bupropion Hydrochloride Extended-release (SR) tablets safely and effectively. See full prescribing information for Bupropion Hydrochloride Extended-release (SR) tablets. BUPROPION hydrochloride extended-release tablets USP (SR) for oral use Initial U.S. Approval: 1985

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-0289-1bupropion57 in 1 BOTTLETABLET, EXTENDED RELEASE572
50436-0289-2bupropion60 in 1 BOTTLETABLET, EXTENDED RELEASE602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0289BUPROPION (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [UNIT DOSE SERVICES]2Legacy NDC, 2 package rows20190222_25e92816-5015-45be-9b6c-17277ab16515.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSN25e92816-5015-45be-9b6c-17277ab165152
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD25e92816-5015-45be-9b6c-17277ab165152
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSY25e92816-5015-45be-9b6c-17277ab165152

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-0289-15043602890157 in 1 BOTTLEHistorical
50436-0289-25043602890260 in 1 BOTTLEHistorical