FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
45865-632
11-digit product format
458650632
Labeler code
45865
Product ID
45865-632_9ab34379-9dc6-7398-e053-2995a90a7336
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUPROPION HYDROCHLORIDE
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Medsource Pharmaceuticals
Application
ANDA077415
Marketing category
ANDA
Marketing start
2009-05-01
Marketing end
0000-00-00
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
2020-12-31
Current FDA listing
Historical FDA.report record

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
45865-632-302025-01-30C16284748780-12cef2736-88b5-d83d-e063-dadaa90ab31fThese 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
45865-632-602025-01-30C16284748780-12cef2736-88b5-d83d-e063-dadaa90ab31fThese 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
45865-632-30Bupropion Hydrochloride30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE302
45865-632-60Bupropion Hydrochloride60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE602

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUPROPION HYDROCHLORIDEACTIVE INGREDIENTZG7E5POY8OBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]1
BUPROPIONACTIVE MOIETY01ZG3TPX31BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOABUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ABUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]1
TRIACETININACTIVE INGREDIENTXHX3C3X673BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-632BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]2Legacy NDC, 2 package rows20191228_1f7fd914-0978-664e-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN1f7fd914-0978-664e-e054-00144ff88e882
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD1f7fd914-0978-664e-e054-00144ff88e882
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY1f7fd914-0978-664e-e054-00144ff88e882

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
45865-632-304586506323030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (45865-632-30) 2015-09-110000-00-00NoNoCurrent
45865-632-604586506326060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (45865-632-60) 2015-09-110000-00-00NoNoCurrent