FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
67046-082
11-digit product format
670460082
Labeler code
67046
Product ID
67046-082_5a45c22c-dd14-5bd3-e053-2991aa0aaf92
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion Hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA077284
Marketing category
ANDA
Marketing start
2017-09-28
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
67046-082-072020-01-31C16284748780-19d75b9d1-1029-f424-e053-dadaa90a57ce082 Bupropion XL 150 mg These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (XL) safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (XL). BuPROPion Hydrochloride Extended-Release Tablets, USP for oral use Initial U.S. Approval: 1985
67046-082-142020-01-31C16284748780-19d75b9d1-1029-f424-e053-dadaa90a57ce082 Bupropion XL 150 mg These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (XL) safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (XL). BuPROPion Hydrochloride Extended-Release Tablets, USP for oral use Initial U.S. Approval: 1985
67046-082-152020-01-31C16284748780-19d75b9d1-1029-f424-e053-dadaa90a57ce082 Bupropion XL 150 mg These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (XL) safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (XL). BuPROPion Hydrochloride Extended-Release Tablets, USP for oral use Initial U.S. Approval: 1985
67046-082-202020-01-31C16284748780-19d75b9d1-1029-f424-e053-dadaa90a57ce082 Bupropion XL 150 mg These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (XL) safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (XL). BuPROPion Hydrochloride Extended-Release Tablets, USP for oral use Initial U.S. Approval: 1985
67046-082-212020-01-31C16284748780-19d75b9d1-1029-f424-e053-dadaa90a57ce082 Bupropion XL 150 mg These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (XL) safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (XL). BuPROPion Hydrochloride Extended-Release Tablets, USP for oral use Initial U.S. Approval: 1985
67046-082-282020-01-31C16284748780-19d75b9d1-1029-f424-e053-dadaa90a57ce082 Bupropion XL 150 mg These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (XL) safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (XL). BuPROPion Hydrochloride Extended-Release Tablets, USP for oral use Initial U.S. Approval: 1985
67046-082-302020-01-31C16284748780-19d75b9d1-1029-f424-e053-dadaa90a57ce082 Bupropion XL 150 mg These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (XL) safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (XL). BuPROPion Hydrochloride Extended-Release Tablets, USP for oral use Initial U.S. Approval: 1985
67046-082-602020-01-31C16284748780-19d75b9d1-1029-f424-e053-dadaa90a57ce082 Bupropion XL 150 mg These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (XL) safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (XL). BuPROPion Hydrochloride Extended-Release Tablets, USP for oral use Initial U.S. Approval: 1985

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-082-07Bupropion Hydrochloride7 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE71
67046-082-14Bupropion Hydrochloride14 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE141
67046-082-15Bupropion Hydrochloride15 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE151
67046-082-20Bupropion Hydrochloride20 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE201
67046-082-21Bupropion Hydrochloride21 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE211
67046-082-28Bupropion Hydrochloride28 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE281
67046-082-30Bupropion Hydrochloride30 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE301
67046-082-60Bupropion Hydrochloride60 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-082BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 8 package rows20170929_5a45c22c-dd13-5bd3-e053-2991aa0aaf92.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN5a45c22c-dd13-5bd3-e053-2991aa0aaf921
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD5a45c22c-dd13-5bd3-e053-2991aa0aaf921
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY5a45c22c-dd13-5bd3-e053-2991aa0aaf921

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67046-082-07670460082077 in 1 BLISTER PACKHistorical
67046-082-146704600821414 in 1 BLISTER PACKHistorical
67046-082-156704600821515 in 1 BLISTER PACKHistorical
67046-082-206704600822020 in 1 BLISTER PACKHistorical
67046-082-216704600822121 in 1 BLISTER PACKHistorical
67046-082-286704600822828 in 1 BLISTER PACKHistorical
67046-082-306704600823030 in 1 BLISTER PACKHistorical
67046-082-606704600826060 in 1 BLISTER PACKHistorical