FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
80425-0539
11-digit product format
804250539
Labeler code
80425
Product ID
80425-0539_3d826804-6428-aae1-e063-6394a90a6593
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA207479
Marketing category
ANDA
Marketing start
2025-08-29
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
Brand name suffix
(XL)
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
80425-0539-1Bupropion Hydrochloride(XL)30 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE301
80425-0539-2Bupropion Hydrochloride(XL)60 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE601
80425-0539-3Bupropion Hydrochloride(XL)90 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0539-1EA - Each80425-05390e505be2-bc36-46c9-b52d-aab67f29020912025-10-14
80425-0539-2EA - Each80425-05398f4a85e9-ba0c-486a-b2c3-e269d2ce3bf912025-10-14
80425-0539-3EA - Each80425-053900dcc17a-6090-48e9-902f-e7ecbc997ed412025-10-14

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSN3d826804-6427-aae1-e063-6394a90a65931
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCD3d826804-6427-aae1-e063-6394a90a65931
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSY3d826804-6427-aae1-e063-6394a90a65931

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
80425-0539-18042505390130 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (80425-0539-1) 2025-08-29NoNoHistorical
80425-0539-28042505390260 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (80425-0539-2) 2025-08-29NoNoHistorical
80425-0539-38042505390390 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (80425-0539-3) 2025-08-29NoNoHistorical