FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
71610-570
11-digit product format
716100570
Labeler code
71610
Product ID
71610-570_4b54424e-e3c5-40d0-bf13-65e689d7123a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA205794
Marketing category
ANDA
Marketing start
2018-05-15
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
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
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
b8ee525f-67fb-39fb-91da-7e47ac54581dProduct name520200611
2e254488-9fcb-41b3-a7c3-e2c9a3941b29Product name120200603
b4ff0805-126a-406d-9cae-fc34fd8e8889Product name120190711
98e65af1-f5d0-75d5-c930-f8a4ce4c3284Product name920190211
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
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
71610-570-602023-01-30C16284748780-1f386c649-bdd7-0266-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
71610-570-802023-01-30C16284748780-1f386c649-bdd7-0266-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
71610-570-60Bupropion Hydrochloride SR90 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE901
71610-570-80Bupropion Hydrochloride SR180 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-570-60EA - Each71610-57058e3390a-0512-4236-83d5-89d544fbf3a112021-09-07
71610-570-80EA - Each71610-570151f23b6-b9e7-4dcd-b06a-7698831cb4ae12021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-570BUPROPION HYDROCHLORIDE SR (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 2 package rows20210803_0d231c6d-539c-4d02-a1ec-bbd799ccfee7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSN0d231c6d-539c-4d02-a1ec-bbd799ccfee71
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD0d231c6d-539c-4d02-a1ec-bbd799ccfee71
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSY0d231c6d-539c-4d02-a1ec-bbd799ccfee71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-570-607161005706090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-570-60) 2021-06-150000-00-00NoNoCurrent
71610-570-8071610057080180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-570-80) 2021-06-150000-00-00NoNoCurrent