BuPROPion Hydrochloride

Product NDC
52959-806
11-digit product format
529590806
Labeler code
52959
Product ID
52959-806_6587b0ef-0ce7-4dca-96fb-b07fc0155fd2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BuPROPion Hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA079095
Marketing category
ANDA
Marketing start
2009-07-02
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
E
Listing certified through
2017-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-806-30BuPROPion Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE303
52959-806-60BuPROPion Hydrochloride60 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-806-30EA - Each52959-806700ffcd6-1a65-4c96-8c12-fbfbaaaa4c0612012-07-24
52959-806-60EA - Each52959-8062413645b-cc15-4c2f-986c-2054911592b812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUPROPION HYDROCHLORIDEACTIVE INGREDIENTZG7E5POY8OBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.]3
BUPROPIONACTIVE MOIETY01ZG3TPX31BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.]3
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.]3
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.]3
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.]3
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ABUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-806BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.]3Legacy NDC, 2 package rows20120120_9c6e2044-c040-403c-bcd6-99ca1e6bba73.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSN9c6e2044-c040-403c-bcd6-99ca1e6bba733
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD9c6e2044-c040-403c-bcd6-99ca1e6bba733
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSY9c6e2044-c040-403c-bcd6-99ca1e6bba733

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-806-305295908063030 in 1 BOTTLE, PLASTICHistorical
52959-806-605295908066060 in 1 BOTTLE, PLASTICHistorical