FDA.reportPublic FDA data

Bupropion hydrochloride (XL)

Product NDC
71335-1542
11-digit product format
713351542
Labeler code
71335
Product ID
71335-1542_cacdf07a-142b-400b-bac5-bddc457cb8a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA208652
Marketing category
ANDA
Marketing start
2018-01-08
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1542-1Bupropion hydrochloride (XL)30 in 1 BOTTLETABLET, EXTENDED RELEASE306
71335-1542-2Bupropion hydrochloride (XL)60 in 1 BOTTLETABLET, EXTENDED RELEASE606
71335-1542-3Bupropion hydrochloride (XL)90 in 1 BOTTLETABLET, EXTENDED RELEASE906
71335-1542-4Bupropion hydrochloride (XL)120 in 1 BOTTLETABLET, EXTENDED RELEASE1206

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1542BUPROPION HYDROCHLORIDE (XL) (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]6Legacy NDC, 4 package rows20200919_7e8ffc37-4bc2-4844-adb5-c7bbc318c623.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN7e8ffc37-4bc2-4844-adb5-c7bbc318c6236
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSN7e8ffc37-4bc2-4844-adb5-c7bbc318c6236
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD7e8ffc37-4bc2-4844-adb5-c7bbc318c6236
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCD7e8ffc37-4bc2-4844-adb5-c7bbc318c6236
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY7e8ffc37-4bc2-4844-adb5-c7bbc318c6236
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSY7e8ffc37-4bc2-4844-adb5-c7bbc318c6236

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1542-17133515420130 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1542-1) 2020-03-270000-00-00NoNoCurrent
71335-1542-27133515420260 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1542-2) 2020-03-270000-00-00NoNoCurrent
71335-1542-37133515420390 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1542-3) 2020-03-270000-00-00NoNoCurrent
71335-1542-471335154204120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1542-4) 2020-03-270000-00-00NoNoCurrent