FDA.reportPublic FDA data

BUPROPION HYDROCHLORIDE SR

Product NDC
72189-349
11-digit product format
721890349
Labeler code
72189
Product ID
72189-349_2c4c85cc-c2b6-ac98-e063-6294a90a973c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUPROPION HYDROCHLORIDE SR
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
DirectRx
Application
ANDA205794
Marketing category
ANDA
Marketing start
2022-04-22
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
Rxcui993518

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
72189-349-30BUPROPION HYDROCHLORIDE SR30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE304
72189-349-60BUPROPION HYDROCHLORIDE SR60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-349-30EA - Each72189-349510f01d0-058b-4df4-8098-1428005ffe9e12022-09-12
72189-349-60EA - Each72189-34947a07f50-2ef0-409c-aa80-356500ba8ae412022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-349BUPROPION HYDROCHLORIDE SR TABLET, FILM COATED, EXTENDED RELEASE [DIRECTRX]4Current NDC, Legacy NDC, 2 package rows20250123_dd4041cd-00e4-d10f-e053-2a95a90a5945.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSNdd4041cd-00e4-d10f-e053-2a95a90a59454
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDdd4041cd-00e4-d10f-e053-2a95a90a59454
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSYdd4041cd-00e4-d10f-e053-2a95a90a59454

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72189-349-307218903493030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72189-349-30) 2022-08-090000-00-00NoNoCurrent
72189-349-607218903496060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72189-349-60) 2022-04-220000-00-00NoNoCurrent