FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
50090-5334
11-digit product format
500905334
Labeler code
50090
Product ID
50090-5334_c799e3b4-7b1b-440e-ad0a-02eee6a2d8df
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA210081
Marketing category
ANDA
Marketing start
2018-08-30
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
Brand name suffix
(XL)
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5334-02023-06-29C16284748780-1f386c64a-1df0-0266-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 USP (XL), for oral use Initial U.S. Approval: 1985
50090-5334-12023-06-29C16284748780-1f386c64a-1df0-0266-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 USP (XL), for oral use Initial U.S. Approval: 1985
50090-5334-02023-01-30C16284748780-1f386c64a-1df0-0266-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 USP (XL), for oral use Initial U.S. Approval: 1985
50090-5334-12023-01-30C16284748780-1f386c64a-1df0-0266-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 USP (XL), for oral use Initial U.S. Approval: 1985

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5334-0Bupropion Hydrochloride(XL)30 in 1 BOTTLETABLET, EXTENDED RELEASE303
50090-5334-1Bupropion Hydrochloride(XL)90 in 1 BOTTLETABLET, EXTENDED RELEASE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5334-0EA - Each50090-533413004834-457a-43c5-a813-3d52f906f7e712023-08-08
50090-5334-1EA - Each50090-533498cc7f4d-8d94-4863-8ebd-fd7a8727677512023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5334BUPROPION HYDROCHLORIDE (XL) (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]3Current NDC, Legacy NDC, 2 package rows20230630_ef8ef9ba-ab2a-4af9-ac11-12dd1b603a4a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSNef8ef9ba-ab2a-4af9-ac11-12dd1b603a4a3
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCDef8ef9ba-ab2a-4af9-ac11-12dd1b603a4a3
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSYef8ef9ba-ab2a-4af9-ac11-12dd1b603a4a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5334-05009053340030 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-5334-0) 2020-11-030000-00-00NoNoCurrent
50090-5334-15009053340190 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-5334-1) 2020-11-030000-00-00NoNoCurrent