BUPROPION HYDROCHLORIDE

Product NDC
64679-830
11-digit product format
646790830
Labeler code
64679
Product ID
64679-830_a73acc01-a46f-4bd9-93bc-a0651059014e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Wockhardt USA LLC.
Application
NDA022497
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2018-08-09
Marketing end
0000-00-00
Substance
BUPROPION HYDROCHLORIDE
Active strength
450 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
64679-830-022020-01-31C16284748780-19d75b9d0-0a9f-f424-e053-dadaa90a57ceb5d04313-790c-44a1-a5ca-4003491337b2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64679-830-01EA - Each64679-8301395a804-d04a-4088-816e-4b77cab0060312018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64679-830BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC.]5Legacy NDC20240701_2e3f36e9-1cb7-4987-92c9-2d9fc519c694.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
64679-830-016467908300130 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (64679-830-01) 2018-08-090000-00-00NoNoCurrent