FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
50090-1059
11-digit product format
500901059
Labeler code
50090
Product ID
50090-1059_ea23f324-2686-4c97-953b-7bdabb05b1d2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion Hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA077284
Marketing category
ANDA
Marketing start
2007-06-12
Marketing end
0000-00-00
Substance
BUPROPION HYDROCHLORIDE
Active strength
300 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
2022-12-31
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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-1059-02023-01-30C16284748780-1f386c64a-2f8e-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (XL) safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (XL). BuPROPion Hydrochloride Extended-Release Tablets, USP for oral use Initial U.S. Approval: 1985
50090-1059-12023-01-30C16284748780-1f386c64a-2f8e-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (XL) safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (XL). BuPROPion Hydrochloride Extended-Release Tablets, USP for oral use Initial U.S. Approval: 1985

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1059-0Bupropion Hydrochloride30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE3018
50090-1059-1Bupropion Hydrochloride90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE9018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1059-0EA - Each50090-1059e77bcad6-2fa2-4c7f-affe-7ccc9325576712018-11-06
50090-1059-1EA - Each50090-105931dea25d-e1d1-46ce-850f-b052ebeffc4f12018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1059BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]18Legacy NDC, 2 package rows20210223_49b86092-60a9-486e-98ca-ecd77e38c5dc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSN49b86092-60a9-486e-98ca-ecd77e38c5dc18
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCD49b86092-60a9-486e-98ca-ecd77e38c5dc18
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSY49b86092-60a9-486e-98ca-ecd77e38c5dc18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-1059-05009010590030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-1059-0) 2014-11-280000-00-00NoNoCurrent
50090-1059-15009010590190 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-1059-1) 2014-11-280000-00-00NoNoCurrent