FDA.reportPublic FDA data

Bupropion hydrochloride

Product NDC
67046-1648
11-digit product format
670461648
Labeler code
67046
Product ID
67046-1648_48726fc1-9885-0f7e-e063-6394a90a8905
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Coupler LLC
Application
ANDA215568
Marketing category
ANDA
Marketing start
2026-01-15
Substance
BUPROPION HYDROCHLORIDE
Active strength
300 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 HYDROCHLORIDE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZG7E5POY8O
Rxcui993557

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4eceb285-f3c7-4092-a21a-4c9f3169f20cProduct name520260220
548ba7fd-fd0c-4a21-b2b0-d01bf93143b8Product name320240209
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
67046-1648-3Bupropion hydrochloride30 in 1 BLISTER PACKTABLET, EXTENDED RELEASE301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSN487271f1-c956-086a-e063-6394a90a2dc71
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCD487271f1-c956-086a-e063-6394a90a2dc71
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSY487271f1-c956-086a-e063-6394a90a2dc71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
67046-1648-36704616480330 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (67046-1648-3) 2026-01-15NoNoHistorical