FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
50090-6789
11-digit product format
500906789
Labeler code
50090
Product ID
50090-6789_8ab0c758-843a-4b62-8635-fb4f32918205
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090693
Marketing category
ANDA
Marketing start
2017-06-14
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Bupropion Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPROPION HYDROCHLORIDE150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZG7E5POY8O
Rxcui993541

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
50090-6789-0Bupropion Hydrochloride90 in 1 BOTTLETABLET, EXTENDED RELEASE907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6789-0EA - Each50090-678966e50f93-34f8-4e01-b7fd-c1f3db4c72cc12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6789BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]5Current NDC, 1 package rows20250131_039d4368-c764-463a-b0cd-1cac702b8fb2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN039d4368-c764-463a-b0cd-1cac702b8fb27
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD039d4368-c764-463a-b0cd-1cac702b8fb27
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY039d4368-c764-463a-b0cd-1cac702b8fb27

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-6789-05009067890090 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-6789-0) 2023-10-31NoNoHistorical