FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
0185-1111
11-digit product format
001851111
Labeler code
0185
Product ID
0185-1111_93be4c14-9bab-40e5-884b-5d3cb377210f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Eon Labs, Inc.
Application
ANDA075932
Marketing category
ANDA
Marketing start
2005-06-22
Marketing end
2025-07-31
Substance
BUPROPION HYDROCHLORIDE
Active strength
200 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
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4eceb285-f3c7-4092-a21a-4c9f3169f20cProduct name520260220
548ba7fd-fd0c-4a21-b2b0-d01bf93143b8Product name320240209
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
b8ee525f-67fb-39fb-91da-7e47ac54581dProduct name520200611
98e65af1-f5d0-75d5-c930-f8a4ce4c3284Product name920190211
e4d463bc-c674-43cb-be06-82786f310d01Product name120150326
0916dcfb-331f-89b1-8eac-6f7dc76d82daProduct name120140508
d7fc3d53-5a6c-de82-2808-1780f175f17eProduct name120140508

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0185-1111BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [EON LABS, INC.]28Legacy NDC20220513_165475dd-a250-48bb-b4c8-65c189194a9b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993536buPROPion HCl 200 MG 12HR Extended Release Oral TabletPSN32ce3963-6ad7-4e5b-9364-4c3282bc921f4
99353612 HR bupropion hydrochloride 200 MG Extended Release Oral TabletSCD32ce3963-6ad7-4e5b-9364-4c3282bc921f4
993536bupropion hydrochloride 200 MG 12 HR Extended Release Oral TabletSY32ce3963-6ad7-4e5b-9364-4c3282bc921f4
993503buPROPion HCl 100 MG 12HR Extended Release Oral TabletPSN5036aa56-e21a-4971-a399-057a77377f4c2
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSN5036aa56-e21a-4971-a399-057a77377f4c2
993536buPROPion HCl 200 MG 12HR Extended Release Oral TabletPSN5036aa56-e21a-4971-a399-057a77377f4c2
99350312 HR bupropion hydrochloride 100 MG Extended Release Oral TabletSCD5036aa56-e21a-4971-a399-057a77377f4c2
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD5036aa56-e21a-4971-a399-057a77377f4c2
99353612 HR bupropion hydrochloride 200 MG Extended Release Oral TabletSCD5036aa56-e21a-4971-a399-057a77377f4c2
993503bupropion HCl 100 MG 12 HR Extended Release Oral TabletSY5036aa56-e21a-4971-a399-057a77377f4c2
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSY5036aa56-e21a-4971-a399-057a77377f4c2
993536bupropion hydrochloride 200 MG 12 HR Extended Release Oral TabletSY5036aa56-e21a-4971-a399-057a77377f4c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0185-1111-0100185111101100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0185-1111-01) 2005-06-220000-00-00NoNoCurrent
0185-1111-0500185111105500 TABLET, EXTENDED RELEASE in 1 BOTTLE (0185-1111-05) 2005-06-220000-00-00NoNoCurrent
0185-1111-10001851111101000 TABLET, EXTENDED RELEASE in 1 BOTTLE (0185-1111-10) 2005-06-220000-00-00NoNoCurrent
0185-1111-5200185111152250 TABLET, EXTENDED RELEASE in 1 BOTTLE (0185-1111-52) 2005-06-220000-00-00NoNoCurrent
0185-1111-600018511116060 TABLET, EXTENDED RELEASE in 1 BOTTLE (0185-1111-60) 2005-06-222025-03-31NoNoCurrent