BUPROPION HCl ER (XL)

Product NDC
70756-830
11-digit product format
707560830
Labeler code
70756
Product ID
70756-830_ee47c513-8459-4292-b727-111b0bd1dbcc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUPROPION HCl ER
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Lifestar Pharma LLC
Application
NDA022497
Marketing category
NDA
Marketing start
2026-05-01
Substance
BUPROPION HYDROCHLORIDE
Active strength
450 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
BUPROPION HCl ER (XL)
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPROPION HYDROCHLORIDE450 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZG7E5POY8O
Rxcui1232585

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70756-830-16BUPROPION HCl ER (XL)16000 in 1 BOXTABLET, EXTENDED RELEASE160001
70756-830-30BUPROPION HCl ER (XL)30 in 1 BOTTLETABLET, EXTENDED RELEASE301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1232585buPROPion HCl 450 MG 24HR Extended Release Oral TabletPSNdf959e1b-3f6d-42cf-8521-fe03b5a4ceb81
123258524 HR bupropion hydrochloride 450 MG Extended Release Oral TabletSCDdf959e1b-3f6d-42cf-8521-fe03b5a4ceb81
1232585bupropion hydrochloride 450 MG 24 HR Extended Release Oral TabletSYdf959e1b-3f6d-42cf-8521-fe03b5a4ceb81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70756-830-167075608301616000 TABLET, EXTENDED RELEASE in 1 BOX (70756-830-16) 2026-05-01NoNoCurrent
70756-830-307075608303030 TABLET, EXTENDED RELEASE in 1 BOTTLE (70756-830-30) 2026-05-01NoNoCurrent