Bupropion Hydrochloride

Product NDC
72789-377
11-digit product format
727890377
Labeler code
72789
Product ID
72789-377_31f65e02-c804-9e8b-e063-6294a90a1815
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA210015
Marketing category
ANDA
Marketing start
2023-04-30
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
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
72789-377-907278903779090 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-377-90) 2024-01-30NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Bupropion Hydrochloride XLPD-Rx Pharmaceuticals, Inc.2025-04-04HUMAN PRESCRIPTION DRUG LABEL6