Bupropion hydrochloride

Product NDC
68258-7157
11-digit product format
682587157
Labeler code
68258
Product ID
68258-7157_1638838c-d5e5-46f3-b5f1-f8332b3beb42
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Dispensing Solutions, Inc.
Application
ANDA078866
Marketing category
ANDA
Marketing start
2010-04-08
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
b8ee525f-67fb-39fb-91da-7e47ac54581dProduct name520200611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
98e65af1-f5d0-75d5-c930-f8a4ce4c3284Product name920190211
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
e4d463bc-c674-43cb-be06-82786f310d01Product name120150326
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
0916dcfb-331f-89b1-8eac-6f7dc76d82daProduct name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508
d7fc3d53-5a6c-de82-2808-1780f175f17eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68258-7157-3Bupropion hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE302
68258-7157-6Bupropion hydrochloride60 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE602
68258-7157-9Bupropion hydrochloride90 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE902

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUPROPION HYDROCHLORIDEACTIVE INGREDIENTZG7E5POY8OBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]2
BUPROPIONACTIVE MOIETY01ZG3TPX31BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]2
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]2
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]2
SACCHARININACTIVE INGREDIENTFST467XS7DBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68258-7157BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]2Legacy NDC, 3 package rows20131031_4705fc95-3b94-41e6-a636-306c3c214a43.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993503buPROPion HCl 100 MG 12HR Extended Release Oral TabletPSN4705fc95-3b94-41e6-a636-306c3c214a432
99350312 HR bupropion hydrochloride 100 MG Extended Release Oral TabletSCD4705fc95-3b94-41e6-a636-306c3c214a432
993503bupropion HCl 100 MG 12 HR Extended Release Oral TabletSY4705fc95-3b94-41e6-a636-306c3c214a432

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68258-7157-36825871570330 in 1 BOTTLE, PLASTICHistorical
68258-7157-66825871570660 in 1 BOTTLE, PLASTICHistorical
68258-7157-96825871570990 in 1 BOTTLE, PLASTICHistorical