FDA.reportPublic FDA data

BuPROPion Hydrochloride

Product NDC
21695-019
11-digit product format
216950019
Labeler code
21695
Product ID
21695-019_5649e22a-aec5-4bb8-83d7-35623185bd34
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BuPROPion Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Rebel Distributors Corp.
Application
ANDA079095
Marketing category
ANDA
Marketing start
2009-09-01
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
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
21695-019-602019-09-24C16284748780-1934fe258-4c26-48b1-e053-8cdaa90a720aBuPROPion Hydrochloride Extended-release Tablets USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-019-60BuPROPion Hydrochloride60 in 1 BOTTLETABLET, EXTENDED RELEASE601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-019-60EA - Each21695-0191b772737-89e5-497c-bd3a-b7549c818eef12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUPROPION HYDROCHLORIDEACTIVE INGREDIENTZG7E5POY8OBUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.]1
BUPROPIONACTIVE MOIETY01ZG3TPX31BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBBUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PBUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XBUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ABUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-019BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP.]1Legacy NDC, 1 package rows20100415_e3fb04de-2a55-456f-8ecc-ac44dc8e5b5a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993503buPROPion HCl 100 MG 12HR Extended Release Oral TabletPSNe3fb04de-2a55-456f-8ecc-ac44dc8e5b5a1
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSNe3fb04de-2a55-456f-8ecc-ac44dc8e5b5a1
993536buPROPion HCl 200 MG 12HR Extended Release Oral TabletPSNe3fb04de-2a55-456f-8ecc-ac44dc8e5b5a1
99350312 HR bupropion hydrochloride 100 MG Extended Release Oral TabletSCDe3fb04de-2a55-456f-8ecc-ac44dc8e5b5a1
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDe3fb04de-2a55-456f-8ecc-ac44dc8e5b5a1
99353612 HR bupropion hydrochloride 200 MG Extended Release Oral TabletSCDe3fb04de-2a55-456f-8ecc-ac44dc8e5b5a1
993503bupropion HCl 100 MG 12 HR Extended Release Oral TabletSYe3fb04de-2a55-456f-8ecc-ac44dc8e5b5a1
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSYe3fb04de-2a55-456f-8ecc-ac44dc8e5b5a1
993536bupropion hydrochloride 200 MG 12 HR Extended Release Oral TabletSYe3fb04de-2a55-456f-8ecc-ac44dc8e5b5a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-019-602169500196060 in 1 BOTTLEHistorical