BUPROPION HYDROCHLORIDE

Product NDC
0615-8582
11-digit product format
006158582
Labeler code
0615
Product ID
0615-8582_4f5269c7-b48c-4855-8a4b-6852522d3aea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUPROPION HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
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
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, 993691

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
0615-8582-39BUPROPION HYDROCHLORIDE30 in 1 BLISTER PACKTABLET, FILM COATED301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993687buPROPion HCl 100 MG Oral TabletPSN4fbe64aa-f8f4-45fa-88ae-e844997703ae1
993691buPROPion HCl 75 MG Oral TabletPSN4fbe64aa-f8f4-45fa-88ae-e844997703ae1
993687bupropion hydrochloride 100 MG Oral TabletSCD4fbe64aa-f8f4-45fa-88ae-e844997703ae1
993691bupropion hydrochloride 75 MG Oral TabletSCD4fbe64aa-f8f4-45fa-88ae-e844997703ae1
993691bupropion HCl 75 MG Oral TabletSY4fbe64aa-f8f4-45fa-88ae-e844997703ae1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0615-8582-390061585823930 TABLET, FILM COATED in 1 BLISTER PACK (0615-8582-39) 2025-07-18NoNoHistorical