FDA.reportPublic FDA data

BUPROPION HYDROCHLORIDE

Product NDC
50090-7511
11-digit product format
500907511
Labeler code
50090
Product ID
50090-7511_50dbf53d-e998-4b27-98de-df9c41df3687
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUPROPION HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA075491
Marketing category
ANDA
Marketing start
2024-04-25
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
BUPROPION HYDROCHLORIDE
Listing expiration
2027-12-31

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-7511-0BUPROPION HYDROCHLORIDE60 in 1 BOTTLETABLET, FILM COATED603
50090-7511-3BUPROPION HYDROCHLORIDE90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7511-0EA - Each50090-751135624653-8ee5-4218-b006-246585ec746812025-05-14
50090-7511-3EA - Each50090-75115dbc08ad-9dcb-48b6-8bd6-d77bd470aee012025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7511BUPROPION HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]1Current NDC, 2 package rows20250227_d86e26e0-6e10-4d59-8cc8-94b551774b86.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993687buPROPion HCl 100 MG Oral TabletPSNd86e26e0-6e10-4d59-8cc8-94b551774b863
993687bupropion hydrochloride 100 MG Oral TabletSCDd86e26e0-6e10-4d59-8cc8-94b551774b863

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7511-05009075110060 TABLET, FILM COATED in 1 BOTTLE (50090-7511-0) 2025-02-20NoNoHistorical
50090-7511-35009075110390 TABLET, FILM COATED in 1 BOTTLE (50090-7511-3) 2025-02-20NoNoHistorical