FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
50090-1150
11-digit product format
500901150
Labeler code
50090
Product ID
50090-1150_f3c02405-f0db-47fe-b943-fa20fdc1f432
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA079094
Marketing category
ANDA
Marketing start
2009-06-11
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
Brand name suffix
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1150-0Bupropion HydrochlorideSR60 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE6018
50090-1150-1Bupropion HydrochlorideSR30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE3018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1150-0EA - Each50090-115096c3cd20-2c27-43ed-92af-ec3c8f99cbab12018-11-06
50090-1150-1EA - Each50090-1150f354b0d4-44b9-49d2-bea2-b22817e7689712018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1150BUPROPION HYDROCHLORIDE SR (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]18Current NDC, Legacy NDC, 2 package rows20231210_dfb45438-1116-48f2-9bfe-776ebbf1e119.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1801289buPROPion HCl 150 MG Smoking Cessation 12HR Extended Release Oral TabletPSNdfb45438-1116-48f2-9bfe-776ebbf1e11918
1801289Smoking Cessation 12 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDdfb45438-1116-48f2-9bfe-776ebbf1e11918
1801289bupropion HCl 150 MG Smoking Cessation 12 HR Extended Release Oral TabletSYdfb45438-1116-48f2-9bfe-776ebbf1e11918

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-1150-05009011500060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50090-1150-0) 2014-11-280000-00-00NoNoCurrent
50090-1150-15009011500130 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-1150-1) 2014-11-280000-00-00NoNoCurrent