bupropion hydrochloride

Product NDC
47781-637
11-digit product format
477810637
Labeler code
47781
Product ID
47781-637_ff963f16-8f76-66a6-25aa-fe2020be1fb0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Alvogen Inc.
Application
NDA022497
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2018-09-28
Marketing end
0000-00-00
Substance
BUPROPION HYDROCHLORIDE
Active strength
450 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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47781-637-30EA - Each47781-63796c8b0fe-5486-4b56-a77b-00f0fce1985012018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47781-637BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [ALVOGEN INC.]5Legacy NDC20240430_a032e7c8-33f2-5fdb-62d7-8517072d1d10.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
47781-637-304778106373030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47781-637-30) 2018-09-280000-00-00NoNoCurrent