bupropion hydrochloride

Product NDC
70377-034
11-digit product format
703770034
Labeler code
70377
Product ID
70377-034_1976a35a-d4d0-4a6a-b406-1821aba2e6c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Biocon Pharma Inc.,
Application
ANDA211020
Marketing category
ANDA
Marketing start
2019-01-28
Marketing end
0000-00-00
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
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70377-034-11EA - Each70377-0349b5f224f-8b4c-4374-8350-882489cca23b12019-10-07
70377-034-12EA - Each70377-03462612aa8-8a60-4f08-9c01-ab12e5d0f1cb12019-10-07
70377-034-13EA - Each70377-03438e84baf-114d-44a7-9cbd-332865b1887412019-10-07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70377-034-117037700341130 TABLET, EXTENDED RELEASE in 1 BOTTLE (70377-034-11) 2019-01-280000-00-00NoNoCurrent
70377-034-127037700341290 TABLET, EXTENDED RELEASE in 1 BOTTLE (70377-034-12) 2019-01-280000-00-00NoNoCurrent
70377-034-1370377003413500 TABLET, EXTENDED RELEASE in 1 BOTTLE (70377-034-13) 2019-01-280000-00-00NoNoCurrent