Bupropion hydrochloride

Product NDC
58657-711
11-digit product format
586570711
Labeler code
58657
Product ID
58657-711_eda14047-eca7-59c5-e053-2a95a90ab9f0
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
58657-711-30EA - Each58657-711ff322d23-154b-405a-8d99-b5a037e464c312022-02-07
58657-711-50EA - Each58657-71167fe3743-1f40-4be7-a455-8f7501d5a6f112022-02-07
58657-711-90EA - Each58657-7119030560d-cb8e-4c15-82b6-ca5a184befbc12022-02-07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
58657-711-305865707113030 TABLET, EXTENDED RELEASE in 1 BOTTLE (58657-711-30) 2019-01-280000-00-00NoNoCurrent
58657-711-5058657071150500 TABLET, EXTENDED RELEASE in 1 BOTTLE (58657-711-50) 2019-01-280000-00-00NoNoCurrent
58657-711-905865707119090 TABLET, EXTENDED RELEASE in 1 BOTTLE (58657-711-90) 2019-01-280000-00-00NoNoCurrent