FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
71335-1551
11-digit product format
713351551
Labeler code
71335
Product ID
71335-1551_a40f6960-de12-452e-a112-f7a83d604011
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA203013
Marketing category
ANDA
Marketing start
2018-06-18
Marketing end
0000-00-00
Substance
BUPROPION HYDROCHLORIDE
Active strength
75 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1551-1Bupropion Hydrochloride30 in 1 BOTTLETABLET, FILM COATED301
71335-1551-2Bupropion Hydrochloride60 in 1 BOTTLETABLET, FILM COATED601
71335-1551-3Bupropion Hydrochloride90 in 1 BOTTLETABLET, FILM COATED901
71335-1551-4Bupropion Hydrochloride7 in 1 BOTTLETABLET, FILM COATED71
71335-1551-5Bupropion Hydrochloride14 in 1 BOTTLETABLET, FILM COATED141
71335-1551-6Bupropion Hydrochloride120 in 1 BOTTLETABLET, FILM COATED1201
71335-1551-7Bupropion Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1551BUPROPION HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1Legacy NDC, 7 package rows20200523_6a300adb-b1c2-4250-bd15-272b04699edd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993691buPROPion HCl 75 MG Oral TabletPSN6a300adb-b1c2-4250-bd15-272b04699edd1
993691bupropion hydrochloride 75 MG Oral TabletSCD6a300adb-b1c2-4250-bd15-272b04699edd1
993691bupropion HCl 75 MG Oral TabletSY6a300adb-b1c2-4250-bd15-272b04699edd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1551-17133515510130 TABLET, FILM COATED in 1 BOTTLE (71335-1551-1) 2020-03-300000-00-00NoNoCurrent
71335-1551-27133515510260 TABLET, FILM COATED in 1 BOTTLE (71335-1551-2) 2020-03-300000-00-00NoNoCurrent
71335-1551-37133515510390 TABLET, FILM COATED in 1 BOTTLE (71335-1551-3) 2020-03-300000-00-00NoNoCurrent
71335-1551-4713351551047 TABLET, FILM COATED in 1 BOTTLE (71335-1551-4) 2020-03-300000-00-00NoNoCurrent
71335-1551-57133515510514 TABLET, FILM COATED in 1 BOTTLE (71335-1551-5) 2020-03-300000-00-00NoNoCurrent
71335-1551-671335155106120 TABLET, FILM COATED in 1 BOTTLE (71335-1551-6) 2020-03-300000-00-00NoNoCurrent
71335-1551-771335155107100 TABLET, FILM COATED in 1 BOTTLE (71335-1551-7) 2020-03-300000-00-00NoNoCurrent