FDA.reportPublic FDA data

BUPROPION HYDROCHLORIDE (SR)

Product NDC
50090-5101
11-digit product format
500905101
Labeler code
50090
Product ID
50090-5101_65817f64-2d82-4dc7-8a8a-cab01892826a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA206122
Marketing category
ANDA
Marketing start
2016-08-17
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
BUPROPION HYDROCHLORIDE (SR)
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPROPION HYDROCHLORIDE150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZG7E5POY8O
Rxcui1801289

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
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5101-0BUPROPION HYDROCHLORIDE (SR)60 in 1 BOTTLETABLET, EXTENDED RELEASE6012
50090-5101-1BUPROPION HYDROCHLORIDE (SR)30 in 1 BOTTLETABLET, EXTENDED RELEASE3012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5101-0EA - Each50090-510115e4cde8-3045-4352-a07d-39bb1bc03e8712024-12-10
50090-5101-1EA - Each50090-5101072d847b-c18a-4c71-8c88-1271fa61f97812024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5101BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]9Current NDC, Legacy NDC, 2 package rows20231216_994229b0-e190-49e3-83ce-6a2063f7335a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1801289buPROPion HCl 150 MG Smoking Cessation 12HR Extended Release Oral TabletPSN994229b0-e190-49e3-83ce-6a2063f7335a12
1801289Smoking Cessation 12 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD994229b0-e190-49e3-83ce-6a2063f7335a12
1801289bupropion HCl 150 MG Smoking Cessation 12 HR Extended Release Oral TabletSY994229b0-e190-49e3-83ce-6a2063f7335a12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5101-05009051010060 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-5101-0) 2020-07-130000-00-00NoNoCurrent
50090-5101-15009051010130 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-5101-1) 2020-07-130000-00-00NoNoCurrent