FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
67544-464
11-digit product format
675440464
Labeler code
67544
Product ID
67544-464_e7ff7ec1-7773-4156-b2c4-f1b3d3ca8d07
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
2003-11-25
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
2019-12-31
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
67544-464-512020-01-31C16284748780-19d75b9cf-ecab-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use BuPROPion HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR) safely and effectively. See full prescribing information for BuPROPion HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR) . BuPROPion HYDROCHLORIDE extended-release tablets (SR), for oral use . Initial U.S. Approval: 1985
67544-464-532020-01-31C16284748780-19d75b9cf-ecab-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use BuPROPion HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR) safely and effectively. See full prescribing information for BuPROPion HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR) . BuPROPion HYDROCHLORIDE extended-release tablets (SR), for oral use . Initial U.S. Approval: 1985
67544-464-822020-01-31C16284748780-19d75b9cf-ecab-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use BuPROPion HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR) safely and effectively. See full prescribing information for BuPROPion HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR) . BuPROPion HYDROCHLORIDE extended-release tablets (SR), for oral use . Initial U.S. Approval: 1985

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67544-464-51Bupropion Hydrochloride6000 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE60002
67544-464-53Bupropion Hydrochloride60 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE602
67544-464-82Bupropion Hydrochloride1200 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE12002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67544-464BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Legacy NDC, 3 package rows20171223_f7364c33-09f8-4113-8cdb-fb8f2aec71de.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993503buPROPion HCl 100 MG 12HR Extended Release Oral TabletPSNf7364c33-09f8-4113-8cdb-fb8f2aec71de2
99350312 HR bupropion hydrochloride 100 MG Extended Release Oral TabletSCDf7364c33-09f8-4113-8cdb-fb8f2aec71de2
993503bupropion HCl 100 MG 12 HR Extended Release Oral TabletSYf7364c33-09f8-4113-8cdb-fb8f2aec71de2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67544-464-51675440464516000 in 1 BOTTLE, PLASTICHistorical
67544-464-536754404645360 in 1 BOTTLE, PLASTICHistorical
67544-464-82675440464821200 in 1 BOTTLE, PLASTICHistorical