FDA.reportPublic FDA data

BUPROPION HYDROCHLORIDE

Product NDC
50090-5163
11-digit product format
500905163
Labeler code
50090
Product ID
50090-5163_6f3ebf11-0131-4add-860d-3c3fe243d5ee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUPROPION HYDROCHLORIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA210497
Marketing category
ANDA
Marketing start
2018-11-08
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
Listing expiration
2026-12-31

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
2e254488-9fcb-41b3-a7c3-e2c9a3941b29Product name120200603
b4ff0805-126a-406d-9cae-fc34fd8e8889Product name120190711
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
50090-5163-0BUPROPION HYDROCHLORIDE90 in 1 BOTTLETABLET, EXTENDED RELEASE909
50090-5163-1BUPROPION HYDROCHLORIDE30 in 1 BOTTLETABLET, EXTENDED RELEASE309
50090-5163-2BUPROPION HYDROCHLORIDE60 in 1 BOTTLETABLET, EXTENDED RELEASE609

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5163-0EA - Each50090-51632982299a-27f1-4b82-8ba6-96a52cb2065812022-01-06
50090-5163-1EA - Each50090-516324178dae-1224-4725-8633-740f173ae3d212022-10-06
50090-5163-2EA - Each50090-516317807bc8-ecbb-46b3-9b07-aecbbaa7798612022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5163BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]9Current NDC, Legacy NDC, 3 package rows20240522_77b78d35-40f5-4713-8468-aa09a6c2925d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN77b78d35-40f5-4713-8468-aa09a6c2925d9
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD77b78d35-40f5-4713-8468-aa09a6c2925d9
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY77b78d35-40f5-4713-8468-aa09a6c2925d9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5163-05009051630090 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-5163-0) 2020-09-230000-00-00NoNoCurrent
50090-5163-15009051630130 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-5163-1) 2020-09-230000-00-00NoNoCurrent
50090-5163-25009051630260 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-5163-2) 2020-09-230000-00-00NoNoCurrent