FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
71335-0013
11-digit product format
713350013
Labeler code
71335
Product ID
71335-0013_c9822446-5f21-4d08-983a-226b3557f18d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
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
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 HYDROCHLORIDE75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZG7E5POY8O
Rxcui993691

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
71335-0013-1Bupropion Hydrochloride30 in 1 BOTTLETABLET, FILM COATED30106
71335-0013-2Bupropion Hydrochloride60 in 1 BOTTLETABLET, FILM COATED60106
71335-0013-3Bupropion Hydrochloride90 in 1 BOTTLETABLET, FILM COATED90106
71335-0013-4Bupropion Hydrochloride7 in 1 BOTTLETABLET, FILM COATED7106
71335-0013-5Bupropion Hydrochloride14 in 1 BOTTLETABLET, FILM COATED14106
71335-0013-6Bupropion Hydrochloride120 in 1 BOTTLETABLET, FILM COATED120106
71335-0013-7Bupropion Hydrochloride100 in 1 BOTTLETABLET, FILM COATED100106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0013-1EA - Each71335-00138299d03c-53e3-4ee5-b954-40c2b07650c712018-04-19
71335-0013-2EA - Each71335-0013ba0022aa-328a-4a3e-8c9e-fa89fd242c2912018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0013BUPROPION HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]105Current NDC, Legacy NDC, 7 package rows20240724_1d722dc2-7909-454e-b989-095677079044.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993691buPROPion HCl 75 MG Oral TabletPSN1d722dc2-7909-454e-b989-095677079044106
993691bupropion hydrochloride 75 MG Oral TabletSCD1d722dc2-7909-454e-b989-095677079044106
993691bupropion HCl 75 MG Oral TabletSY1d722dc2-7909-454e-b989-095677079044106

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0013-17133500130130 TABLET, FILM COATED in 1 BOTTLE (71335-0013-1) 2018-03-080000-00-00NoNoCurrent
71335-0013-27133500130260 TABLET, FILM COATED in 1 BOTTLE (71335-0013-2) 2018-02-210000-00-00NoNoCurrent
71335-0013-37133500130390 TABLET, FILM COATED in 1 BOTTLE (71335-0013-3) 2024-07-090000-00-00NoNoCurrent
71335-0013-4713350013047 TABLET, FILM COATED in 1 BOTTLE (71335-0013-4) 2024-07-090000-00-00NoNoCurrent
71335-0013-57133500130514 TABLET, FILM COATED in 1 BOTTLE (71335-0013-5) 2024-07-090000-00-00NoNoCurrent
71335-0013-671335001306120 TABLET, FILM COATED in 1 BOTTLE (71335-0013-6) 2024-07-090000-00-00NoNoCurrent
71335-0013-771335001307100 TABLET, FILM COATED in 1 BOTTLE (71335-0013-7) 2024-07-090000-00-00NoNoCurrent