BUPROPION HYDROCHLORIDE

Product NDC
61919-063
11-digit product format
619190063
Labeler code
61919
Product ID
61919-063_9c5b0a2c-cf1e-85e5-e053-2995a90a783b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUPROPION HYDROCHLORIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA075932
Marketing category
ANDA
Marketing start
2019-07-29
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
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
61919-063-722020-01-31C16284748780-19d75b9d0-27f4-f424-e053-dadaa90a57ceBUPROPION HYDROCHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-063-72BUPROPION HYDROCHLORIDE120 in 1 BOTTLETABLET, EXTENDED RELEASE1201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-063BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [DIRECT RX]1Legacy NDC, 1 package rows20170216_48a7e42b-9360-4ec6-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSN48a7e42b-9360-4ec6-e054-00144ff88e881
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD48a7e42b-9360-4ec6-e054-00144ff88e881
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSY48a7e42b-9360-4ec6-e054-00144ff88e881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-063-306191900633030 TABLET, EXTENDED RELEASE in 1 BOTTLE (61919-063-30) 2019-07-290000-00-00NoNoCurrent
61919-063-7261919006372120 in 1 BOTTLEHistorical