BUPROPION HYDROCHLORIDE

Product NDC
72189-124
11-digit product format
721890124
Labeler code
72189
Product ID
72189-124_2c4ea3ff-7a39-c7f4-e063-6294a90a5746
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUPROPION HYDROCHLORIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
DIRECT RX
Application
ANDA210497
Marketing category
ANDA
Marketing start
2020-08-14
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
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 formatDescriptionMarketing startSampleExclude flagStatus
72189-124-307218901243030 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-124-30) 2020-08-14NoNoHistorical
72189-124-7272189012472120 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-124-72) 2020-08-14NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
BUPROPIONDIRECT RX2025-01-22HUMAN PRESCRIPTION DRUG LABEL18