FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
50268-142
11-digit product format
502680142
Labeler code
50268
Product ID
50268-142_4b95b3fd-3945-41d9-e063-6294a90a34ed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AvPAK
Application
ANDA076143
Marketing category
ANDA
Marketing start
2017-08-02
Substance
BUPROPION HYDROCHLORIDE
Active strength
75 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Bupropion Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPROPION HYDROCHLORIDE75 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
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
50268-142-11Bupropion Hydrochloride1 in 1 BLISTER PACKTABLET, FILM COATED18
50268-142-15Bupropion Hydrochloride50 in 1 BOX, UNIT-DOSETABLET, FILM COATED508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-142-11EA - Each50268-1427c8b001a-1167-462c-a157-4f3a7399e96f12017-11-06
50268-142-15EA - Each50268-142c55c56f7-b4dc-4629-af87-01b73579ee3112017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-142BUPROPION HYDROCHLORIDE TABLET, FILM COATED [AVPAK]6Current NDC, Legacy NDC, 2 package rows20240110_bcb4ef83-f272-4090-8547-9aaf4ab63667.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993687buPROPion HCl 100 MG Oral TabletPSNbcb4ef83-f272-4090-8547-9aaf4ab636678
993691buPROPion HCl 75 MG Oral TabletPSNbcb4ef83-f272-4090-8547-9aaf4ab636678
993687bupropion hydrochloride 100 MG Oral TabletSCDbcb4ef83-f272-4090-8547-9aaf4ab636678
993691bupropion hydrochloride 75 MG Oral TabletSCDbcb4ef83-f272-4090-8547-9aaf4ab636678
993691bupropion HCl 75 MG Oral TabletSYbcb4ef83-f272-4090-8547-9aaf4ab636678

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-142-11502680142111 in 1 BLISTER PACKHistorical
50268-142-155026801421550 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-142-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-142-11) 50 blister pack2017-08-020000-00-00NoNoCurrent