Bupropion hydrochloride

Product NDC
58657-710
11-digit product format
586570710
Labeler code
58657
Product ID
58657-710_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
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
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
58657-710-30EA - Each58657-710b7d74edc-04ae-459f-ad80-c74998486a3d12022-02-07
58657-710-50EA - Each58657-7106d878ee2-3c31-49e8-8567-72c704c1817212022-02-07
58657-710-90EA - Each58657-710bb846f03-e02d-4d2d-a70e-6e4ea4bc7df912022-02-07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
58657-710-305865707103030 TABLET, EXTENDED RELEASE in 1 BOTTLE (58657-710-30) 2019-01-280000-00-00NoNoCurrent
58657-710-5058657071050500 TABLET, EXTENDED RELEASE in 1 BOTTLE (58657-710-50) 2019-01-280000-00-00NoNoCurrent
58657-710-905865707109090 TABLET, EXTENDED RELEASE in 1 BOTTLE (58657-710-90) 2019-01-280000-00-00NoNoCurrent