FDA.reportPublic FDA data

BUPROPION HYDROCHLORIDE (SR)

Product NDC
43598-863
11-digit product format
435980863
Labeler code
43598
Product ID
43598-863_4486fd29-bab2-59ee-e063-6294a90a4fd2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Dr. Reddy's Laboratories Inc
Application
ANDA206122
Marketing category
ANDA
Marketing start
2016-08-17
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
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPROPION HYDROCHLORIDE150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZG7E5POY8O
Rxcui1801289

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
2e254488-9fcb-41b3-a7c3-e2c9a3941b29Product name120200603
b4ff0805-126a-406d-9cae-fc34fd8e8889Product name120190711
98e65af1-f5d0-75d5-c930-f8a4ce4c3284Product name920190211
e4d463bc-c674-43cb-be06-82786f310d01Product name120150326
0916dcfb-331f-89b1-8eac-6f7dc76d82daProduct name120140508
d7fc3d53-5a6c-de82-2808-1780f175f17eProduct name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43598-863-10BUPROPION HYDROCHLORIDE (SR)1000 in 1 BOTTLETABLET, EXTENDED RELEASE10006
43598-863-30BUPROPION HYDROCHLORIDE (SR)30 in 1 BOTTLETABLET, EXTENDED RELEASE306
43598-863-60BUPROPION HYDROCHLORIDE (SR)60 in 1 BOTTLETABLET, EXTENDED RELEASE606

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-863-60EA - Each43598-8638888cb0f-ab2b-45df-b6fc-f272b8718f3112019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-863BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DR. REDDY'S LABORATORIES INC]5Current NDC, Legacy NDC, 3 package rows20241031_8069c521-c49a-4b6d-baa8-4b0be897d585.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1801289buPROPion HCl 150 MG Smoking Cessation 12HR Extended Release Oral TabletPSN994229b0-e190-49e3-83ce-6a2063f7335a12
1801289Smoking Cessation 12 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD994229b0-e190-49e3-83ce-6a2063f7335a12
1801289bupropion HCl 150 MG Smoking Cessation 12 HR Extended Release Oral TabletSY994229b0-e190-49e3-83ce-6a2063f7335a12
1801289buPROPion HCl 150 MG Smoking Cessation 12HR Extended Release Oral TabletPSN8069c521-c49a-4b6d-baa8-4b0be897d5856
1801289Smoking Cessation 12 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD8069c521-c49a-4b6d-baa8-4b0be897d5856
1801289bupropion HCl 150 MG Smoking Cessation 12 HR Extended Release Oral TabletSY8069c521-c49a-4b6d-baa8-4b0be897d5856

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43598-863-10435980863101000 TABLET, EXTENDED RELEASE in 1 BOTTLE (43598-863-10) 2016-08-170000-00-00NoNoCurrent
43598-863-304359808633030 TABLET, EXTENDED RELEASE in 1 BOTTLE (43598-863-30) 2016-08-170000-00-00NoNoCurrent
43598-863-604359808636060 TABLET, EXTENDED RELEASE in 1 BOTTLE (43598-863-60) 2016-08-170000-00-00NoNoCurrent