FDA.reportPublic FDA data

Bupropion hydrochloride (XL)

Product NDC
53002-1508
11-digit product format
530021508
Labeler code
53002
Product ID
53002-1508_2912de2a-80ce-4cf4-8be4-08140d68278f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA208652
Marketing category
ANDA
Marketing start
2018-01-08
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
2021-12-31
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
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
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
53002-1508-32023-01-30C16284748780-19d75b9d0-6496-f424-e053-dadaa90a57ceThese 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, for oral use Initial U.S. Approval: 1985
53002-1508-32020-12-15C16284748780-19d75b9d0-6496-f424-e053-dadaa90a57ceThese 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, for oral use Initial U.S. Approval: 1985
53002-1508-32020-01-31C16284748780-19d75b9d0-6496-f424-e053-dadaa90a57ceThese 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, for oral use Initial U.S. Approval: 1985

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-1508-3Bupropion hydrochloride (XL)30 in 1 BOTTLETABLET, EXTENDED RELEASE303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-1508BUPROPION HYDROCHLORIDE (XL) (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [RPK PHARMACEUTICALS, INC.]3Legacy NDC, 1 package rows20201217_fe1db54b-d9ef-40b4-bc89-1369be50936a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSNfe1db54b-d9ef-40b4-bc89-1369be50936a3
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCDfe1db54b-d9ef-40b4-bc89-1369be50936a3
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSYfe1db54b-d9ef-40b4-bc89-1369be50936a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53002-1508-35300215080330 TABLET, EXTENDED RELEASE in 1 BOTTLE (53002-1508-3) 2018-10-010000-00-00NoNoCurrent