FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
50090-4049
11-digit product format
500904049
Labeler code
50090
Product ID
50090-4049_1b5f8619-c60e-4e63-857b-3cb582b64276
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion Hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA077715
Marketing category
ANDA
Marketing start
2008-11-26
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
Brand name suffix
XL
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
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
50090-4049-02023-08-09C16284748780-1f386c649-afc5-0266-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
50090-4049-02023-01-30C16284748780-1f386c649-afc5-0266-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
50090-4049-0Bupropion HydrochlorideXL90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE904
50090-4049-1Bupropion HydrochlorideXL30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE304
50090-4049-2Bupropion HydrochlorideXL60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4049-0EA - Each50090-404915241165-31ba-4a87-b802-e9cfd3bbe41312023-09-05
50090-4049-1EA - Each50090-404963cc627c-91da-4a1b-a06e-57a4109ec57612023-09-05
50090-4049-2EA - Each50090-404908fe4463-1f51-4d4f-ae85-66644e0daafe12023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4049BUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]4Current NDC, Legacy NDC, 3 package rows20230810_9d08b4ae-077d-4cd8-9ca4-8d5cd63f400b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN9d08b4ae-077d-4cd8-9ca4-8d5cd63f400b4
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD9d08b4ae-077d-4cd8-9ca4-8d5cd63f400b4
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY9d08b4ae-077d-4cd8-9ca4-8d5cd63f400b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4049-05009040490090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-4049-0) 2019-01-110000-00-00NoNoCurrent
50090-4049-15009040490130 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-4049-1) 2019-01-11NoNoHistorical
50090-4049-25009040490260 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-4049-2) 2019-01-11NoNoHistorical