FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
68788-7988
11-digit product format
687887988
Labeler code
68788
Product ID
68788-7988_c315824b-c5d7-4e7a-942b-1c502c05bbbd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA076143
Marketing category
ANDA
Marketing start
2021-08-06
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
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 HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZG7E5POY8O
Rxcui993687

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
68788-7988-1Bupropion Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1007
68788-7988-3Bupropion Hydrochloride30 in 1 BOTTLETABLET, FILM COATED307
68788-7988-6Bupropion Hydrochloride60 in 1 BOTTLETABLET, FILM COATED607
68788-7988-9Bupropion Hydrochloride90 in 1 BOTTLETABLET, FILM COATED907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7988-3EA - Each68788-798812873e91-8c77-4883-81a3-3bdb442fb5e912021-09-07
68788-7988-6EA - Each68788-7988edde1acb-59eb-4c80-b34d-bea5a93761e112021-09-07
68788-7988-9EA - Each68788-79883620f21d-9625-4cc4-afa8-4b2ee671bd2912021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7988BUPROPION HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]5Current NDC, Legacy NDC, 4 package rows20250213_eabb54b7-164c-4de8-b91a-f2e65637b5fc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993687buPROPion HCl 100 MG Oral TabletPSNeabb54b7-164c-4de8-b91a-f2e65637b5fc7
993687bupropion hydrochloride 100 MG Oral TabletSCDeabb54b7-164c-4de8-b91a-f2e65637b5fc7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7988-168788798801100 TABLET, FILM COATED in 1 BOTTLE (68788-7988-1) 2024-03-11NoNoHistorical
68788-7988-36878879880330 TABLET, FILM COATED in 1 BOTTLE (68788-7988-3) 2021-08-060000-00-00NoNoCurrent
68788-7988-66878879880660 TABLET, FILM COATED in 1 BOTTLE (68788-7988-6) 2021-08-060000-00-00NoNoCurrent
68788-7988-96878879880990 TABLET, FILM COATED in 1 BOTTLE (68788-7988-9) 2021-08-060000-00-00NoNoCurrent