FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
55648-101
11-digit product format
556480101
Labeler code
55648
Product ID
55648-101_572fcaa4-314e-42b2-aa6b-f5ec54da6199
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion Hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Wockhardt Limited
Application
ANDA201331
Marketing category
ANDA
Marketing start
2012-08-30
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
No
Listing certified through
2019-12-31
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
b8ee525f-67fb-39fb-91da-7e47ac54581dProduct name520200611
98e65af1-f5d0-75d5-c930-f8a4ce4c3284Product name920190211
e4d463bc-c674-43cb-be06-82786f310d01Product name120150326
0916dcfb-331f-89b1-8eac-6f7dc76d82daProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
d7fc3d53-5a6c-de82-2808-1780f175f17eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55648-101-012020-01-31C16284748780-19d75b9d1-1725-f424-e053-dadaa90a57cePRESCRIBING INFORMATION Bupropion Hydrochloride Extended-Release Tablets, USP (SR)
55648-101-022020-01-31C16284748780-19d75b9d1-1725-f424-e053-dadaa90a57cePRESCRIBING INFORMATION Bupropion Hydrochloride Extended-Release Tablets, USP (SR)
55648-101-032020-01-31C16284748780-19d75b9d1-1725-f424-e053-dadaa90a57cePRESCRIBING INFORMATION Bupropion Hydrochloride Extended-Release Tablets, USP (SR)
55648-101-052020-01-31C16284748780-19d75b9d1-1725-f424-e053-dadaa90a57cePRESCRIBING INFORMATION Bupropion Hydrochloride Extended-Release Tablets, USP (SR)
55648-101-072020-01-31C16284748780-19d75b9d1-1725-f424-e053-dadaa90a57cePRESCRIBING INFORMATION Bupropion Hydrochloride Extended-Release Tablets, USP (SR)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55648-101-01Bupropion Hydrochloride(SR)30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE302
55648-101-02Bupropion Hydrochloride(SR)60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE602
55648-101-03Bupropion Hydrochloride(SR)100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1002
55648-101-05Bupropion Hydrochloride(SR)10 in 1 CARTONTABLET, FILM COATED, EXTENDED RE102
55648-101-07Bupropion Hydrochloride(SR)500 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE5002
55648-101-08Bupropion Hydrochloride(SR)10 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE102

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUPROPION HYDROCHLORIDEACTIVE INGREDIENTZG7E5POY8OBUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]2
BUPROPIONACTIVE MOIETY01ZG3TPX31BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]2
AMMONIUM CHLORIDEINACTIVE INGREDIENT01Q9PC255DBUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDBUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKBUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOABUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]2
GLYCERYL DIBEHENATEINACTIVE INGREDIENTR8WTH25YS2BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]2
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PBUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]2
MANNITOLINACTIVE INGREDIENT3OWL53L36ABUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]2
TALCINACTIVE INGREDIENT7SEV7J4R1UBUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55648-101BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]2Legacy NDC, 6 package rows20121107_1a2a5385-ec04-448f-8bdb-d1cc3eb5f1c0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993503buPROPion HCl 100 MG 12HR Extended Release Oral TabletPSN1a2a5385-ec04-448f-8bdb-d1cc3eb5f1c02
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSN1a2a5385-ec04-448f-8bdb-d1cc3eb5f1c02
993536buPROPion HCl 200 MG 12HR Extended Release Oral TabletPSN1a2a5385-ec04-448f-8bdb-d1cc3eb5f1c02
99350312 HR bupropion hydrochloride 100 MG Extended Release Oral TabletSCD1a2a5385-ec04-448f-8bdb-d1cc3eb5f1c02
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD1a2a5385-ec04-448f-8bdb-d1cc3eb5f1c02
99353612 HR bupropion hydrochloride 200 MG Extended Release Oral TabletSCD1a2a5385-ec04-448f-8bdb-d1cc3eb5f1c02
993503bupropion HCl 100 MG 12 HR Extended Release Oral TabletSY1a2a5385-ec04-448f-8bdb-d1cc3eb5f1c02
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSY1a2a5385-ec04-448f-8bdb-d1cc3eb5f1c02
993536bupropion hydrochloride 200 MG 12 HR Extended Release Oral TabletSY1a2a5385-ec04-448f-8bdb-d1cc3eb5f1c02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
55648-101-015564801010130 in 1 BOTTLEHistorical
55648-101-025564801010260 in 1 BOTTLEHistorical
55648-101-0355648010103100 in 1 BOTTLEHistorical
55648-101-055564801010510 in 1 CARTONHistorical
55648-101-0755648010107500 in 1 BOTTLEHistorical
55648-101-085564801010810 in 1 BLISTER PACKHistorical