BUPROPION HYDROCHLORIDE

Product NDC
50090-5245
11-digit product format
500905245
Labeler code
50090
Product ID
50090-5245_276e4e7b-c793-46ae-b05c-9b268b236b6b
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
2019-03-25
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5245-02023-02-07C16284748780-1f386c649-ae97-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (XL) safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (XL). BUPROPION HYDROCHLORIDE extended-release tablets (XL), for oral use Initial U.S. Approval: 1985
50090-5245-12023-02-07C16284748780-1f386c649-ae97-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (XL) safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (XL). BUPROPION HYDROCHLORIDE extended-release tablets (XL), for oral use Initial U.S. Approval: 1985
50090-5245-02023-01-30C16284748780-1f386c649-ae97-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (XL) safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (XL). BUPROPION HYDROCHLORIDE extended-release tablets (XL), for oral use Initial U.S. Approval: 1985
50090-5245-12023-01-30C16284748780-1f386c649-ae97-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (XL) safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (XL). BUPROPION HYDROCHLORIDE extended-release tablets (XL), for oral use Initial U.S. Approval: 1985

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5245-0BUPROPION HYDROCHLORIDE30 in 1 BOTTLETABLET, EXTENDED RELEASE306
50090-5245-1BUPROPION HYDROCHLORIDE90 in 1 BOTTLETABLET, EXTENDED RELEASE906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5245-0EA - Each50090-5245f209fb41-cb46-46c8-acb6-8e90a896950a12023-06-06
50090-5245-1EA - Each50090-52452d4fc290-c5d8-4fd8-8448-66d31575435912023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5245BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]6Current NDC, Legacy NDC, 2 package rows20240517_a18b5460-fcbb-42dd-8b87-197d11a08928.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSNa18b5460-fcbb-42dd-8b87-197d11a089286
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCDa18b5460-fcbb-42dd-8b87-197d11a089286
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSYa18b5460-fcbb-42dd-8b87-197d11a089286

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5245-05009052450030 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-5245-0) 2020-10-120000-00-00NoNoCurrent
50090-5245-15009052450190 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-5245-1) 2020-10-120000-00-00NoNoCurrent