bupropion hydrochloride

Product NDC
70518-4591
11-digit product format
705184591
Labeler code
70518
Product ID
70518-4591_4d745c86-fea0-8d0a-e063-6294a90aea6a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA202304
Marketing category
ANDA
Marketing start
2026-03-20
Substance
BUPROPION HYDROCHLORIDE
Active strength
100 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
2027-12-31
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
70518-4591-07051845910030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (70518-4591-0) 2026-03-20NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
bupropion hydrochloride SRREMEDYREPACK INC.2026-03-20HUMAN PRESCRIPTION DRUG LABEL1