FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
71610-346
11-digit product format
716100346
Labeler code
71610
Product ID
71610-346_2c125891-ab03-4c4f-844e-c0f8de1d370c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA210081
Marketing category
ANDA
Marketing start
2018-08-30
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
71610-346-602023-01-30C16284748780-1f386c649-e5b8-0266-e053-dadaa90a7c1aBUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (XL) These 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 (XL), for oral use Initial U.S. Approval: 1985

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-346-60Bupropion Hydrochloride(XL)90 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-346-60EA - Each71610-3466c3ed56a-94ab-4fb4-8332-c5eef0e1d93712019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-346BUPROPION HYDROCHLORIDE (XL) (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 1 package rows20191017_38aecc00-de96-4479-aa9b-5d09a1529642.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN38aecc00-de96-4479-aa9b-5d09a15296421
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD38aecc00-de96-4479-aa9b-5d09a15296421
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY38aecc00-de96-4479-aa9b-5d09a15296421

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-346-607161003466090 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-346-60) 2019-09-270000-00-00NoNoCurrent