FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
0904-6635
11-digit product format
009046635
Labeler code
0904
Product ID
0904-6635_9e06ea08-4c71-4904-84ce-257d949b3679
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA076143
Marketing category
ANDA
Marketing start
2006-01-17
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
0904-6635-61Bupropion Hydrochloride100 in 1 CARTONTABLET, FILM COATED1008
0904-6635-61Bupropion Hydrochloride1 in 1 BLISTER PACKTABLET, FILM COATED18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6635-61EA - Each0904-6635de31cab2-d55f-47a8-8e0c-650495ab1e4512018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6635BUPROPION HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]5Current NDC, Legacy NDC, 2 package rows20240716_b127d3fc-be5e-4c12-8026-205766bf8e7f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993687buPROPion HCl 100 MG Oral TabletPSNb127d3fc-be5e-4c12-8026-205766bf8e7f8
993691buPROPion HCl 75 MG Oral TabletPSNb127d3fc-be5e-4c12-8026-205766bf8e7f8
993687bupropion hydrochloride 100 MG Oral TabletSCDb127d3fc-be5e-4c12-8026-205766bf8e7f8
993691bupropion hydrochloride 75 MG Oral TabletSCDb127d3fc-be5e-4c12-8026-205766bf8e7f8
993691bupropion HCl 75 MG Oral TabletSYb127d3fc-be5e-4c12-8026-205766bf8e7f8
993691buPROPion HCl 75 MG Oral TabletPSNec4d2256-0340-4166-90ee-c264eef3ac826
993691bupropion hydrochloride 75 MG Oral TabletSCDec4d2256-0340-4166-90ee-c264eef3ac826
993691bupropion HCl 75 MG Oral TabletSYec4d2256-0340-4166-90ee-c264eef3ac826

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6635-6100904663561100 BLISTER PACK in 1 CARTON (0904-6635-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK100 blister pack2006-01-170000-00-00NoNoCurrent