Bupropion Hydrochloride

Product NDC
70518-3058
11-digit product format
705183058
Labeler code
70518
Product ID
70518-3058_ebdf2ebd-50c6-ab45-e053-2995a90ab08f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA211347
Marketing category
ANDA
Marketing start
2021-03-26
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-3058-07051830580030 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-3058-0) 2021-03-260000-00-00NoNoCurrent