FDA.reportPublic FDA data

BUPROPION HYDROCHLORIDE

Product NDC
42571-242
11-digit product format
425710242
Labeler code
42571
Product ID
42571-242_42fa8097-2060-e261-e063-6294a90a6c29
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Micro Labs Limited
Application
ANDA207403
Marketing category
ANDA
Marketing start
2020-07-01
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
Rxcui993687, 993691

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
42571-242-01BUPROPION HYDROCHLORIDE100 in 1 BOTTLETABLET, FILM COATED10013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42571-242BUPROPION HYDROCHLORIDE TABLET, FILM COATED [MICRO LABS LIMITED]11Current NDC, Legacy NDC, 1 package rows20240528_03450d2d-97ce-4518-af15-ab85b0d65d76.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993687buPROPion HCl 100 MG Oral TabletPSN03450d2d-97ce-4518-af15-ab85b0d65d7613
993691buPROPion HCl 75 MG Oral TabletPSN03450d2d-97ce-4518-af15-ab85b0d65d7613
993687bupropion hydrochloride 100 MG Oral TabletSCD03450d2d-97ce-4518-af15-ab85b0d65d7613
993691bupropion hydrochloride 75 MG Oral TabletSCD03450d2d-97ce-4518-af15-ab85b0d65d7613
993691bupropion HCl 75 MG Oral TabletSY03450d2d-97ce-4518-af15-ab85b0d65d7613

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42571-242-0142571024201100 TABLET, FILM COATED in 1 BOTTLE (42571-242-01) 2020-07-010000-00-00NoNoCurrent