Bupropion Hydrochloride

Product NDC
71610-990
11-digit product format
716100990
Labeler code
71610
Product ID
71610-990_4bd451d7-4e0c-3227-e063-6394a90aad6e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA205794
Marketing category
ANDA
Marketing start
2018-04-20
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
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
71610-990-307161009903030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-990-30) 2026-02-27NoNoHistorical
71610-990-537161009905360 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-990-53) 2026-02-27NoNoHistorical
71610-990-607161009906090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-990-60) 2026-02-27NoNoHistorical
71610-990-8071610099080180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-990-80) 2026-02-27NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Bupropion Hydrochloride SRAphena Pharma Solutions - Tennessee, LLC2026-02-27HUMAN PRESCRIPTION DRUG LABEL1