FDA.reportPublic FDA data

bupropion Hydrochloride

Product NDC
71335-0877
11-digit product format
713350877
Labeler code
71335
Product ID
71335-0877_7a02762a-5d8d-4874-9fc2-b4d74458eee7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA207389
Marketing category
ANDA
Marketing start
2018-05-26
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
bupropion Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPROPION HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZG7E5POY8O
Rxcui993687

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
71335-0877-12024-05-16C16284748780-11030e365-189e-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE TABLETS. BUPROPION HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1985
71335-0877-22024-05-16C16284748780-11030e365-189e-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE TABLETS. BUPROPION HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1985
71335-0877-32024-05-16C16284748780-11030e365-189e-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE TABLETS. BUPROPION HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1985
71335-0877-42024-05-16C16284748780-11030e365-189e-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE TABLETS. BUPROPION HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1985
71335-0877-52024-05-16C16284748780-11030e365-189e-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE TABLETS. BUPROPION HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1985
71335-0877-62024-05-16C16284748780-11030e365-189e-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE TABLETS. BUPROPION HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1985
71335-0877-72024-05-16C16284748780-11030e365-189e-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE TABLETS. BUPROPION HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1985
71335-0877-12024-01-30C16284748780-11030e365-189e-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE TABLETS. BUPROPION HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1985
71335-0877-22024-01-30C16284748780-11030e365-189e-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE TABLETS. BUPROPION HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1985
71335-0877-32024-01-30C16284748780-11030e365-189e-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE TABLETS. BUPROPION HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1985
71335-0877-42024-01-30C16284748780-11030e365-189e-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE TABLETS. BUPROPION HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1985
71335-0877-52024-01-30C16284748780-11030e365-189e-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE TABLETS. BUPROPION HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1985
71335-0877-62024-01-30C16284748780-11030e365-189e-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE TABLETS. BUPROPION HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1985
71335-0877-72024-01-30C16284748780-11030e365-189e-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE TABLETS. BUPROPION HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1985

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0877-1bupropion Hydrochloride60 in 1 BOTTLETABLET608
71335-0877-2bupropion Hydrochloride30 in 1 BOTTLETABLET308
71335-0877-3bupropion Hydrochloride100 in 1 BOTTLETABLET1008
71335-0877-4bupropion Hydrochloride90 in 1 BOTTLETABLET908
71335-0877-5bupropion Hydrochloride120 in 1 BOTTLETABLET1208
71335-0877-6bupropion Hydrochloride15 in 1 BOTTLETABLET158
71335-0877-7bupropion Hydrochloride21 in 1 BOTTLETABLET218

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0877BUPROPION HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]8Current NDC, Legacy NDC, 7 package rows20240517_c1fa6fce-272b-4497-a958-177f0bafdfc7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993687buPROPion HCl 100 MG Oral TabletPSNc1fa6fce-272b-4497-a958-177f0bafdfc78
993687bupropion hydrochloride 100 MG Oral TabletSCDc1fa6fce-272b-4497-a958-177f0bafdfc78

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0877-17133508770160 TABLET in 1 BOTTLE (71335-0877-1) 60 tablet2018-09-070000-00-00NoNoCurrent
71335-0877-27133508770230 TABLET in 1 BOTTLE (71335-0877-2) 30 tablet2018-06-210000-00-00NoNoCurrent
71335-0877-371335087703100 TABLET in 1 BOTTLE (71335-0877-3) 100 tablet2021-12-270000-00-00NoNoCurrent
71335-0877-47133508770490 TABLET in 1 BOTTLE (71335-0877-4) 90 tablet2018-09-130000-00-00NoNoCurrent
71335-0877-571335087705120 TABLET in 1 BOTTLE (71335-0877-5) 120 tablet2021-12-270000-00-00NoNoCurrent
71335-0877-67133508770615 TABLET in 1 BOTTLE (71335-0877-6) 15 tablet2021-12-270000-00-00NoNoCurrent
71335-0877-77133508770721 TABLET in 1 BOTTLE (71335-0877-7) 21 tablet2021-12-270000-00-00NoNoCurrent