FDA.reportPublic FDA data

Bupropion hydrochloride

Product NDC
71335-2499
11-digit product format
713352499
Labeler code
71335
Product ID
71335-2499_28a2d1e3-d88b-4312-99a9-54592acd5a27
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA215568
Marketing category
ANDA
Marketing start
2022-12-15
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
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 HYDROCHLORIDE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZG7E5POY8O
Rxcui993557

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
71335-2499-1Bupropion hydrochloride30 in 1 BOTTLETABLET, EXTENDED RELEASE302
71335-2499-2Bupropion hydrochloride60 in 1 BOTTLETABLET, EXTENDED RELEASE602
71335-2499-3Bupropion hydrochloride90 in 1 BOTTLETABLET, EXTENDED RELEASE902
71335-2499-4Bupropion hydrochloride120 in 1 BOTTLETABLET, EXTENDED RELEASE1202
71335-2499-5Bupropion hydrochloride8 in 1 BOTTLETABLET, EXTENDED RELEASE82
71335-2499-6Bupropion hydrochloride180 in 1 BOTTLETABLET, EXTENDED RELEASE1802

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2499BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]2Current NDC, 6 package rows20250122_bf5e933c-8a84-4dd7-a05d-6c4a82b6c965.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSNbf5e933c-8a84-4dd7-a05d-6c4a82b6c9652
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCDbf5e933c-8a84-4dd7-a05d-6c4a82b6c9652
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSYbf5e933c-8a84-4dd7-a05d-6c4a82b6c9652

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2499-17133524990130 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2499-1) 2024-09-23NoNoCurrent
71335-2499-27133524990260 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2499-2) 2024-09-23NoNoCurrent
71335-2499-37133524990390 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2499-3) 2024-09-23NoNoCurrent
71335-2499-471335249904120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2499-4) 2024-09-23NoNoCurrent
71335-2499-5713352499058 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2499-5) 2024-09-23NoNoCurrent
71335-2499-671335249906180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2499-6) 2024-09-23NoNoCurrent