FDA.reportPublic FDA data

Bupropion hydrochloride (XL)

Product NDC
0781-5528
11-digit product format
007815528
Labeler code
0781
Product ID
0781-5528_a7fcc3be-3698-456b-ac4c-860ef32f153a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Sandoz Inc.
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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-5528-10EA - Each0781-5528d72f8c33-92bc-4482-8cd0-51e120737d8612018-03-08
0781-5528-31EA - Each0781-552855505d03-a4a6-43c8-9afc-239d08dbcc8b12018-03-08

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
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN922095b9-54ee-4a7f-91ad-40949f81c6424
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSNb4d20e09-2952-413d-b3f8-4abb4ddf2cbb4
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD922095b9-54ee-4a7f-91ad-40949f81c6424
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDb4d20e09-2952-413d-b3f8-4abb4ddf2cbb4
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY922095b9-54ee-4a7f-91ad-40949f81c6424
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSYb4d20e09-2952-413d-b3f8-4abb4ddf2cbb4
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSNaa0800f6-3234-4908-e053-2a95a90a3a771
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDaa0800f6-3234-4908-e053-2a95a90a3a771
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSYaa0800f6-3234-4908-e053-2a95a90a3a771

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0781-5528-10007815528101000 TABLET, EXTENDED RELEASE in 1 BOTTLE (0781-5528-10) 2018-01-080000-00-00NoNoCurrent
0781-5528-310078155283130 TABLET, EXTENDED RELEASE in 1 BOTTLE (0781-5528-31) 2018-01-080000-00-00NoNoCurrent