Bupropion hydrochloride

Product NDC
70518-4415
11-digit product format
705184415
Labeler code
70518
Product ID
70518-4415_3b8bc854-86ca-2c46-e063-6294a90a8b1e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA215568
Marketing category
ANDA
Marketing start
2025-07-31
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 formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4415-07051844150030 TABLET in 1 BLISTER PACK (70518-4415-0) 30 tablet2025-07-31NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Bupropion hydrochlorideREMEDYREPACK INC.2025-08-04HUMAN PRESCRIPTION DRUG LABEL1