Bupropion Hydrochloride

Product NDC
67046-079
11-digit product format
670460079
Labeler code
67046
Product ID
67046-079_598b0776-3cfd-3044-e053-2a91aa0a6b8d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA075932
Marketing category
ANDA
Marketing start
2004-03-22
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
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
67046-079-072020-01-31C16284748780-19d75b9d0-b8e1-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 . 079 Initial U.S. Approval: 1985
67046-079-142020-01-31C16284748780-19d75b9d0-b8e1-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 . 079 Initial U.S. Approval: 1985
67046-079-152020-01-31C16284748780-19d75b9d0-b8e1-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 . 079 Initial U.S. Approval: 1985
67046-079-212020-01-31C16284748780-19d75b9d0-b8e1-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 . 079 Initial U.S. Approval: 1985
67046-079-282020-01-31C16284748780-19d75b9d0-b8e1-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 . 079 Initial U.S. Approval: 1985
67046-079-302020-01-31C16284748780-19d75b9d0-b8e1-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 . 079 Initial U.S. Approval: 1985

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-079-07Bupropion Hydrochloride7 in 1 BLISTER PACKTABLET, EXTENDED RELEASE71
67046-079-14Bupropion Hydrochloride14 in 1 BLISTER PACKTABLET, EXTENDED RELEASE141
67046-079-15Bupropion Hydrochloride15 in 1 BLISTER PACKTABLET, EXTENDED RELEASE151
67046-079-21Bupropion Hydrochloride21 in 1 BLISTER PACKTABLET, EXTENDED RELEASE211
67046-079-28Bupropion Hydrochloride28 in 1 BLISTER PACKTABLET, EXTENDED RELEASE281
67046-079-30Bupropion Hydrochloride30 in 1 BLISTER PACKTABLET, EXTENDED RELEASE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-079BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 6 package rows20170919_598b0776-3cfc-3044-e053-2a91aa0a6b8d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSN598b0776-3cfc-3044-e053-2a91aa0a6b8d1
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD598b0776-3cfc-3044-e053-2a91aa0a6b8d1
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSY598b0776-3cfc-3044-e053-2a91aa0a6b8d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67046-079-07670460079077 in 1 BLISTER PACKHistorical
67046-079-146704600791414 in 1 BLISTER PACKHistorical
67046-079-156704600791515 in 1 BLISTER PACKHistorical
67046-079-216704600792121 in 1 BLISTER PACKHistorical
67046-079-286704600792828 in 1 BLISTER PACKHistorical
67046-079-306704600793030 in 1 BLISTER PACKHistorical