Bupropion Hydrochloride

Product NDC
68071-3594
11-digit product format
680713594
Labeler code
68071
Product ID
68071-3594_15ad1da5-913c-665c-e063-6394a90a9056
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
NuCare Pharmacueticals, 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
68071-3594-36807135940330 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (68071-3594-3) 2024-04-09NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Bupropion Hydrochloride XLNuCare Pharmacueticals, Inc. | NuCare Phamacueticals, Inc2024-04-09HUMAN PRESCRIPTION DRUG LABEL1