FDA.reportPublic FDA data

BUPROPION HYDROCHLORIDE

Product NDC
59651-875
11-digit product format
596510875
Labeler code
59651
Product ID
59651-875_8ab2cb88-9bc6-4c0c-a97b-3098dbc11a7f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUPROPION HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA075491
Marketing category
ANDA
Marketing start
2024-04-25
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
BUPROPION HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPROPION HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZG7E5POY8O
Rxcui993687, 993691

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59651-875-01BUPROPION HYDROCHLORIDE100 in 1 BOTTLETABLET, FILM COATED1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-875-01EA - Each59651-8754da6c171-fce6-4161-8187-b16561cf654212024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-875BUPROPION HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]2Current NDC, 1 package rows20240612_6563b923-269f-40c3-b992-cbacdfca6e16.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993687buPROPion HCl 100 MG Oral TabletPSN6563b923-269f-40c3-b992-cbacdfca6e164
993691buPROPion HCl 75 MG Oral TabletPSN6563b923-269f-40c3-b992-cbacdfca6e164
993687bupropion hydrochloride 100 MG Oral TabletSCD6563b923-269f-40c3-b992-cbacdfca6e164
993691bupropion hydrochloride 75 MG Oral TabletSCD6563b923-269f-40c3-b992-cbacdfca6e164
993691bupropion HCl 75 MG Oral TabletSY6563b923-269f-40c3-b992-cbacdfca6e164
993687buPROPion HCl 100 MG Oral TabletPSNd86e26e0-6e10-4d59-8cc8-94b551774b863
993687bupropion hydrochloride 100 MG Oral TabletSCDd86e26e0-6e10-4d59-8cc8-94b551774b863
993687buPROPion HCl 100 MG Oral TabletPSN4fbe64aa-f8f4-45fa-88ae-e844997703ae1
993687buPROPion HCl 100 MG Oral TabletPSN9a3b97be-afa3-49e6-962f-662b6807e6071
993691buPROPion HCl 75 MG Oral TabletPSN4fbe64aa-f8f4-45fa-88ae-e844997703ae1
993687bupropion hydrochloride 100 MG Oral TabletSCD4fbe64aa-f8f4-45fa-88ae-e844997703ae1
993687bupropion hydrochloride 100 MG Oral TabletSCD9a3b97be-afa3-49e6-962f-662b6807e6071
993691bupropion hydrochloride 75 MG Oral TabletSCD4fbe64aa-f8f4-45fa-88ae-e844997703ae1
993691bupropion HCl 75 MG Oral TabletSY4fbe64aa-f8f4-45fa-88ae-e844997703ae1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
59651-875-0159651087501100 TABLET, FILM COATED in 1 BOTTLE (59651-875-01) 2024-04-25NoNoHistorical