FDA.reportPublic FDA data

BUPROPION HYDROCHLORIDE

Product NDC
59651-846
11-digit product format
596510846
Labeler code
59651
Product ID
59651-846_b9ab1deb-dba4-4403-9121-936278cc4cfe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUPROPION HYDROCHLORIDE
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA090325
Marketing category
ANDA
Marketing start
2025-06-03
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
Rxcui993503, 993518, 993536

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
59651-846-01BUPROPION HYDROCHLORIDE100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1002
59651-846-05BUPROPION HYDROCHLORIDE500 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE5002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-846-01EA - Each59651-8461a3ff462-dcf8-4a02-9acd-c4e922ee4f2912026-02-05
59651-846-05EA - Each59651-8465c220e9a-bb5f-47da-bd4f-c40064088d7f12026-02-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993503buPROPion HCl 100 MG 12HR Extended Release Oral TabletPSN8f86f677-2ebd-43c4-b2dd-2e07d4d541472
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSN8f86f677-2ebd-43c4-b2dd-2e07d4d541472
993536buPROPion HCl 200 MG 12HR Extended Release Oral TabletPSN8f86f677-2ebd-43c4-b2dd-2e07d4d541472
99350312 HR bupropion hydrochloride 100 MG Extended Release Oral TabletSCD8f86f677-2ebd-43c4-b2dd-2e07d4d541472
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD8f86f677-2ebd-43c4-b2dd-2e07d4d541472
99353612 HR bupropion hydrochloride 200 MG Extended Release Oral TabletSCD8f86f677-2ebd-43c4-b2dd-2e07d4d541472
993503bupropion HCl 100 MG 12 HR Extended Release Oral TabletSY8f86f677-2ebd-43c4-b2dd-2e07d4d541472
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSY8f86f677-2ebd-43c4-b2dd-2e07d4d541472
993536bupropion hydrochloride 200 MG 12 HR Extended Release Oral TabletSY8f86f677-2ebd-43c4-b2dd-2e07d4d541472

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
59651-846-0159651084601100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (59651-846-01) 2025-06-03NoNoHistorical
59651-846-0559651084605500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (59651-846-05) 2025-06-03NoNoHistorical