FDA.reportPublic FDA data

Bupropion HCL ER (XL)

Product NDC
72189-539
11-digit product format
721890539
Labeler code
72189
Product ID
72189-539_19b02d9d-9104-0442-e063-6394a90a3154
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion HCL ER (XL)
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Direct_RX
Application
ANDA210015
Marketing category
ANDA
Marketing start
2024-03-01
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 HCL ER (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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
b8ee525f-67fb-39fb-91da-7e47ac54581dProduct name520200611
2e254488-9fcb-41b3-a7c3-e2c9a3941b29Product name120200603
b4ff0805-126a-406d-9cae-fc34fd8e8889Product name120190711
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
98e65af1-f5d0-75d5-c930-f8a4ce4c3284Product name920190211
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
e4d463bc-c674-43cb-be06-82786f310d01Product name120150326
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
0916dcfb-331f-89b1-8eac-6f7dc76d82daProduct name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508
d7fc3d53-5a6c-de82-2808-1780f175f17eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-539-30Bupropion HCL ER (XL)30 in 1 BOTTLETABLET, EXTENDED RELEASE302
72189-539-90Bupropion HCL ER (XL)90 in 1 BOTTLETABLET, EXTENDED RELEASE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-539-30EA - Each72189-539de90d59a-6039-4585-9bd6-4ece8a43030b12024-04-05
72189-539-90EA - Each72189-5396593f11a-2c22-4740-b641-3738f16c49b212024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-539BUPROPION HCL ER (XL) TABLET, EXTENDED RELEASE [DIRECT_RX]2Current NDC, 2 package rows20240601_129ce80c-0333-873e-e063-6394a90a33e0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSN129ce80c-0333-873e-e063-6394a90a33e02
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCD129ce80c-0333-873e-e063-6394a90a33e02
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSY129ce80c-0333-873e-e063-6394a90a33e02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72189-539-307218905393030 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-539-30) 2024-03-01NoNoHistorical
72189-539-907218905399090 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-539-90) 2024-03-01NoNoHistorical