Bupropion Hydrochloride

Product NDC
83008-082
11-digit product format
830080082
Labeler code
83008
Product ID
83008-082_2f1417b0-2b35-4e9c-a9c4-e17d3d51d8e7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA207479
Marketing category
ANDA
Marketing start
2024-08-28
Marketing end
2026-12-31
Substance
BUPROPION HYDROCHLORIDE
Active strength
150 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
Current FDA listing
Yes

Related Records

Related UNII Ingredients

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

Packages

Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
83008-082-308300800823030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (83008-082-30) 2024-08-282026-12-31NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Bupropion Hydrochloride (XL)Quality Care Products, LLC2024-12-19HUMAN PRESCRIPTION DRUG LABEL4