bupropion hydrochloride

Product NDC
70377-035
11-digit product format
703770035
Labeler code
70377
Product ID
70377-035_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
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
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
70377-035-11EA - Each70377-0352ec396b2-fc55-4fe0-a15d-2bc685dec1ce12019-10-07
70377-035-12EA - Each70377-035c02ff87c-51dc-4d0f-87bd-7765a7fb313012019-10-07
70377-035-13EA - Each70377-035d090ca32-d861-4d9b-8e8e-6eabc00d83e412019-10-07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70377-035-117037700351130 TABLET, EXTENDED RELEASE in 1 BOTTLE (70377-035-11) 2019-01-280000-00-00NoNoCurrent
70377-035-127037700351290 TABLET, EXTENDED RELEASE in 1 BOTTLE (70377-035-12) 2019-01-280000-00-00NoNoCurrent
70377-035-1370377003513500 TABLET, EXTENDED RELEASE in 1 BOTTLE (70377-035-13) 2019-01-280000-00-00NoNoCurrent