Bupropion Hydrochloride

Product NDC
52959-655
11-digit product format
529590655
Labeler code
52959
Product ID
52959-655_1a55e010-4f16-4082-be02-77d7777f8c09
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA075491
Marketing category
ANDA
Marketing start
2010-02-01
Marketing end
0000-00-00
Substance
BUPROPION HYDROCHLORIDE
Active strength
100 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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52959-655-602019-10-29C16284748780-1960f7f55-d3ac-8e05-e053-dbdaa90a074ad06963c7-f6de-484e-a212-34d865939e8e

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-655-60Bupropion Hydrochloride60 in 1 BOTTLE, PLASTICTABLET, FILM COATED601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-655-60EA - Each52959-6556b5cb86a-f9a7-4837-91cb-83a10314546412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUPROPION HYDROCHLORIDEACTIVE INGREDIENTZG7E5POY8OBUPROPION HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
BUPROPIONACTIVE MOIETY01ZG3TPX31BUPROPION HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKBUPROPION HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUPROPION HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKBUPROPION HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKBUPROPION HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8BUPROPION HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBBUPROPION HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOBUPROPION HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEBUPROPION HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ABUPROPION HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUPROPION HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBUPROPION HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBUPROPION HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1
TRIACETININACTIVE INGREDIENTXHX3C3X673BUPROPION HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-655BUPROPION HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]1Legacy NDC, 1 package rows20110831_d06963c7-f6de-484e-a212-34d865939e8e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993687buPROPion HCl 100 MG Oral TabletPSNd06963c7-f6de-484e-a212-34d865939e8e1
993687bupropion hydrochloride 100 MG Oral TabletSCDd06963c7-f6de-484e-a212-34d865939e8e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-655-605295906556060 in 1 BOTTLE, PLASTICHistorical