bupropion Hydrochloride

Product NDC
58118-0191
11-digit product format
581180191
Labeler code
58118
Product ID
58118-0191_b0160a1f-f637-c1f0-e053-2a95a90a7873
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Clinical Solutions Wholesale, LLC
Application
ANDA206975
Marketing category
ANDA
Marketing start
2016-08-19
Marketing end
0000-00-00
Substance
BUPROPION HYDROCHLORIDE
Active strength
75 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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58118-0191-82024-01-30C16284748780-11030e365-37f4-111a-e063-dadaa90a10e2b2711a32-37a1-44c4-9dee-2e299daff0ae

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58118-0191BUPROPION HYDROCHLORIDE TABLET [CLINICAL SOLUTIONS WHOLESALE, LLC]4Legacy NDC20200925_b2711a32-37a1-44c4-9dee-2e299daff0ae.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58118-0191-85811801910830 TABLET in 1 BLISTER PACK (58118-0191-8) 30 tablet2018-02-060000-00-00NoNoCurrent