FDA.reportPublic FDA data

BUPROPION HYDROCHLORIDE

Product NDC
72189-057
11-digit product format
721890057
Labeler code
72189
Product ID
72189-057_2c4ea3ff-7a39-c7f4-e063-6294a90a5746
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUPROPION HYDROCHLORIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
DIRECT RX
Application
ANDA202304
Marketing category
ANDA
Marketing start
2019-11-08
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, 993541, 993557

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-057-30BUPROPION HYDROCHLORIDE30 in 1 BOTTLETABLET, EXTENDED RELEASE3018
72189-057-60BUPROPION HYDROCHLORIDE60 in 1 BOTTLETABLET, EXTENDED RELEASE6018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-057-30EA - Each72189-057c795b9fb-4061-4656-86e4-dd521716ecce12019-12-10
72189-057-60EA - Each72189-057f415b032-85f6-42fc-b94c-d74bd18759ea12020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-057BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [DIRECT RX]18Current NDC, Legacy NDC, 2 package rows20250123_96d87edc-d12b-44b2-e053-2995a90a4e63.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993503buPROPion HCl 100 MG 12HR Extended Release Oral TabletPSN96d87edc-d12b-44b2-e053-2995a90a4e6318
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN96d87edc-d12b-44b2-e053-2995a90a4e6318
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSN96d87edc-d12b-44b2-e053-2995a90a4e6318
99350312 HR bupropion hydrochloride 100 MG Extended Release Oral TabletSCD96d87edc-d12b-44b2-e053-2995a90a4e6318
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD96d87edc-d12b-44b2-e053-2995a90a4e6318
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCD96d87edc-d12b-44b2-e053-2995a90a4e6318
993503bupropion HCl 100 MG 12 HR Extended Release Oral TabletSY96d87edc-d12b-44b2-e053-2995a90a4e6318
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY96d87edc-d12b-44b2-e053-2995a90a4e6318
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSY96d87edc-d12b-44b2-e053-2995a90a4e6318

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72189-057-307218900573030 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-057-30) 2019-11-080000-00-00NoNoCurrent
72189-057-607218900576060 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-057-60) 2019-11-080000-00-00NoNoCurrent