Bupropion Hydrochloride

Product NDC
82804-013
11-digit product format
828040013
Labeler code
82804
Product ID
82804-013_80f4a4ef-8190-458d-af2e-5daaf32abc01
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA206556
Marketing category
ANDA
Marketing start
2016-08-29
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 formatDescriptionMarketing startSampleExclude flagStatus
82804-013-308280400133030 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (82804-013-30) 2023-09-21NoNoHistorical
82804-013-608280400136060 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (82804-013-60) 2023-09-21NoNoHistorical
82804-013-908280400139090 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (82804-013-90) 2023-09-21NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Bupropion Hydrochloride (XL)Proficient Rx LP2023-09-01HUMAN PRESCRIPTION DRUG LABEL1