FDA.reportPublic FDA data

BUPROPION HYDROCHLORIDE (SR)

Product NDC
50090-3453
11-digit product format
500903453
Labeler code
50090
Product ID
50090-3453_71f3e11f-be60-4982-9577-4da32e31cbcf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA206674
Marketing category
ANDA
Marketing start
2016-07-25
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
2020-12-31
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
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
50090-3453-02023-01-30C16284748780-1f386c649-c9b2-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR) safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR). BUPROPION HYDROCHLORIDE extended-release tablets (SR), for oral use Initial U.S. Approval: 1985

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3453-0BUPROPION HYDROCHLORIDE (SR)29 in 1 BOTTLETABLET, EXTENDED RELEASE291

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3453-0EA - Each50090-3453e933d216-c7f7-442f-9e44-a4296500911112019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3453BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]1Legacy NDC, 1 package rows20190205_51720017-e33f-4e3c-8986-a68291ae4879.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSN51720017-e33f-4e3c-8986-a68291ae48791
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD51720017-e33f-4e3c-8986-a68291ae48791
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSY51720017-e33f-4e3c-8986-a68291ae48791

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3453-05009034530029 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-3453-0) 2018-05-100000-00-00NoNoCurrent