FDA.reportPublic FDA data

BUPROPION HYDROCHLORIDE

Product NDC
61919-136
11-digit product format
619190136
Labeler code
61919
Product ID
61919-136_dd2b07ad-bd69-ee94-e053-2a95a90a0bb5
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
2017-07-17
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
2023-12-31
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
61919-136-302025-01-30C16284748780-12cef2736-6007-d83d-e063-dadaa90ab31fBUPROPION HCL ER (SR)
61919-136-602025-01-30C16284748780-12cef2736-6007-d83d-e063-dadaa90ab31fBUPROPION HCL ER (SR)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-136-30BUPROPION HYDROCHLORIDE30 in 1 BOTTLETABLET, EXTENDED RELEASE307
61919-136-60BUPROPION HYDROCHLORIDE60 in 1 BOTTLETABLET, EXTENDED RELEASE607

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-136-30EA - Each61919-136421be5bf-f1bb-4b65-a3f7-88117b7b285c12022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-136BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [DIRECT_RX]7Legacy NDC, 2 package rows20220422_54874d2d-2b13-20d9-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSN54874d2d-2b13-20d9-e054-00144ff8d46c7
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD54874d2d-2b13-20d9-e054-00144ff8d46c7
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSY54874d2d-2b13-20d9-e054-00144ff8d46c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-136-306191901363030 TABLET, EXTENDED RELEASE in 1 BOTTLE (61919-136-30) 2019-09-180000-00-00NoNoCurrent
61919-136-606191901366060 TABLET, EXTENDED RELEASE in 1 BOTTLE (61919-136-60) 2017-07-170000-00-00NoNoCurrent