FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
21695-578
11-digit product format
216950578
Labeler code
21695
Product ID
21695-578_22009d23-999c-4fa6-bfe7-21395f577236
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion Hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA077715
Marketing category
ANDA
Marketing start
2007-06-13
Marketing end
0000-00-00
Substance
BUPROPION HYDROCHLORIDE
Active strength
300 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
21695-578-302019-09-24C16284748780-1934fe258-4c3b-48b1-e053-8cdaa90a720aPRESCRIBING INFORMATION BuPROPion Hydrochloride Extended-Release Tablets (XL) Revised: August 2010 Rx only 174662-3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-578-30Bupropion HydrochlorideXL30 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-578-30EA - Each21695-5780afef7b4-d1f6-4b94-98cf-052e9fdc294112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUPROPION HYDROCHLORIDEACTIVE INGREDIENTZG7E5POY8OBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
BUPROPIONACTIVE MOIETY01ZG3TPX31BUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
ETHYLCELLULOSEINACTIVE INGREDIENT7Z8S9VYZ4BBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
TALCINACTIVE INGREDIENT7SEV7J4R1UBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-578BUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20100921_22009d23-999c-4fa6-bfe7-21395f577236.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN22009d23-999c-4fa6-bfe7-21395f5772361
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSN22009d23-999c-4fa6-bfe7-21395f5772361
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD22009d23-999c-4fa6-bfe7-21395f5772361
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCD22009d23-999c-4fa6-bfe7-21395f5772361
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY22009d23-999c-4fa6-bfe7-21395f5772361
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSY22009d23-999c-4fa6-bfe7-21395f5772361

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-578-302169505783030 in 1 BOTTLE, PLASTICHistorical