Bupropion hydrochloride

Product NDC
58657-713
11-digit product format
586570713
Labeler code
58657
Product ID
58657-713_edb47931-e2a7-4ee7-e053-2995a90a40b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Method Pharmaceuticals, LLC
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
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
58657-713-30EA - Each58657-7136f203d4b-1e04-4e64-8bdd-45ae1ad371de12022-03-09
58657-713-50EA - Each58657-71349b399c5-0952-4d20-9712-f87a7b5774be12022-03-09
58657-713-90EA - Each58657-71315306fc1-a19f-428e-8f4c-00cc79cdb7d112022-03-09

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
58657-713-305865707133030 TABLET, EXTENDED RELEASE in 1 BOTTLE (58657-713-30) 2019-01-280000-00-00NoNoCurrent
58657-713-5058657071350500 TABLET, EXTENDED RELEASE in 1 BOTTLE (58657-713-50) 2019-01-280000-00-00NoNoCurrent
58657-713-905865707139090 TABLET, EXTENDED RELEASE in 1 BOTTLE (58657-713-90) 2019-01-280000-00-00NoNoCurrent