Bupropion Hydrochloride

Product NDC
67046-1587
11-digit product format
670461587
Labeler code
67046
Product ID
67046-1587_3eec6253-ab66-d5b0-e063-6394a90a522d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Coupler LLC
Application
ANDA206975
Marketing category
ANDA
Marketing start
2025-09-16
Substance
BUPROPION HYDROCHLORIDE
Active strength
75 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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
ZG7E5POY8OBUPROPION HYDROCHLORIDE31677-93-7BUPROPION HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67046-1587-36704615870330 TABLET in 1 BLISTER PACK (67046-1587-3) 30 tablet2025-09-16NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Bupropion HydrochlorideCoupler LLC2025-09-16HUMAN PRESCRIPTION DRUG LABEL1