Bupropion Hydrochloride

Product NDC
58118-0415
11-digit product format
581180415
Labeler code
58118
Product ID
58118-0415_b0236193-ca99-2941-e053-2a95a90a03e6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Clinical Solutions Wholesale, LLC
Application
ANDA075932
Marketing category
ANDA
Marketing start
2019-03-06
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
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58118-0415-82024-01-30C16284748780-11030e365-0acc-111a-e063-dadaa90a10e200f9395d-2fe4-4b0c-890a-6873f56fb10a

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58118-0415BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [CLINICAL SOLUTIONS WHOLESALE, LLC]3Legacy NDC20200926_00f9395d-2fe4-4b0c-890a-6873f56fb10a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
58118-0415-85811804150830 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (58118-0415-8) 2019-03-060000-00-00NoNoCurrent