FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
50090-4749
11-digit product format
500904749
Labeler code
50090
Product ID
50090-4749_8848d8d9-7ef9-49e9-9f04-44458b16c5b4
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
300 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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPROPION HYDROCHLORIDE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZG7E5POY8O
Rxcui993557

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
50090-4749-0Bupropion Hydrochloride30 in 1 BOTTLETABLET, EXTENDED RELEASE309
50090-4749-1Bupropion Hydrochloride90 in 1 BOTTLETABLET, EXTENDED RELEASE909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4749-0EA - Each50090-474984a4c5e1-57ca-403c-b863-fd019c0c609212021-08-05
50090-4749-1EA - Each50090-47498eb429c9-be82-4a69-a0ee-bd6cf2f72b9e12022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4749BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]7Current NDC, Legacy NDC, 2 package rows20230510_a0fdfc21-165a-43fa-9b3c-e48f3b892250.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSNa0fdfc21-165a-43fa-9b3c-e48f3b8922509
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCDa0fdfc21-165a-43fa-9b3c-e48f3b8922509
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSYa0fdfc21-165a-43fa-9b3c-e48f3b8922509

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4749-05009047490030 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-4749-0) 2019-11-220000-00-00NoNoCurrent
50090-4749-15009047490190 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-4749-1) 2019-11-220000-00-00NoNoCurrent