FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
50090-1869
11-digit product format
500901869
Labeler code
50090
Product ID
50090-1869_aa89dc60-57fd-465a-9c47-8aa53221bd91
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA076143
Marketing category
ANDA
Marketing start
2006-01-17
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
50090-1869-02023-02-07C16284748780-1f386c649-dbfc-0266-e053-dadaa90a7c1aThese 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
50090-1869-32023-02-07C16284748780-1f386c649-dbfc-0266-e053-dadaa90a7c1aThese 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
50090-1869-02023-01-30C16284748780-1f386c649-dbfc-0266-e053-dadaa90a7c1aThese 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
50090-1869-32023-01-30C16284748780-1f386c649-dbfc-0266-e053-dadaa90a7c1aThese 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
50090-1869-0Bupropion Hydrochloride60 in 1 BOTTLETABLET, FILM COATED6016
50090-1869-3Bupropion Hydrochloride90 in 1 BOTTLETABLET, FILM COATED9016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1869-0EA - Each50090-1869dd0fda70-462a-485c-93e7-a92f63114dac12018-11-06
50090-1869-3EA - Each50090-186972c70e47-cf79-4a15-b72e-b8c5302b444a12018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1869BUPROPION HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]16Current NDC, Legacy NDC, 2 package rows20240601_78ef709a-f835-4b03-92dd-16a4c82af0c1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993687buPROPion HCl 100 MG Oral TabletPSN78ef709a-f835-4b03-92dd-16a4c82af0c116
993687bupropion hydrochloride 100 MG Oral TabletSCD78ef709a-f835-4b03-92dd-16a4c82af0c116

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-1869-05009018690060 TABLET, FILM COATED in 1 BOTTLE (50090-1869-0) 2015-06-100000-00-00NoNoCurrent
50090-1869-35009018690390 TABLET, FILM COATED in 1 BOTTLE (50090-1869-3) 2015-06-100000-00-00NoNoCurrent