FDA.reportPublic FDA data

Bupropion hydrochloride

Product NDC
33358-364
11-digit product format
333580364
Labeler code
33358
Product ID
33358-364_1e1ecdbc-2371-4d40-abfd-eca669ac56a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
RxChange Co.
Application
ANDA078866
Marketing category
ANDA
Marketing start
2010-04-08
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
33358-364-602020-01-31C16284748780-19d75b9d0-bec6-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE. BUPROPION HYDROCHLORIDE extended-release tablets, USP (SR) for oral use Initial U.S. Approval: 1985

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33358-364-60Bupropion hydrochloride60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33358-364-60EA - Each33358-3643a07ccbe-ecf2-4f83-b577-73c903fd4f0c12015-01-05

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33358-364BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [RXCHANGE CO.]2Legacy NDC, 1 package rows20141202_f800ac11-136e-4f5c-a04f-b1c8d441433c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSNf800ac11-136e-4f5c-a04f-b1c8d441433c2
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDf800ac11-136e-4f5c-a04f-b1c8d441433c2
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSYf800ac11-136e-4f5c-a04f-b1c8d441433c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33358-364-603335803646060 in 1 BOTTLEHistorical