FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
71335-0182
11-digit product format
713350182
Labeler code
71335
Product ID
71335-0182_a3743344-f956-4c63-985a-9aaaeeaad923
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
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

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
71335-0182-1Bupropion Hydrochloride60 in 1 BOTTLETABLET, FILM COATED6022
71335-0182-2Bupropion Hydrochloride30 in 1 BOTTLETABLET, FILM COATED3022
71335-0182-3Bupropion Hydrochloride100 in 1 BOTTLETABLET, FILM COATED10022
71335-0182-4Bupropion Hydrochloride90 in 1 BOTTLETABLET, FILM COATED9022
71335-0182-5Bupropion Hydrochloride120 in 1 BOTTLETABLET, FILM COATED12022
71335-0182-6Bupropion Hydrochloride15 in 1 BOTTLETABLET, FILM COATED1522
71335-0182-7Bupropion Hydrochloride21 in 1 BOTTLETABLET, FILM COATED2122

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0182-1EA - Each71335-01822c6ae369-1aee-4872-be23-c2c565353d1a12023-12-05
71335-0182-2EA - Each71335-018268a42366-14fb-419f-bc49-e79a4ceac65112018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0182BUPROPION HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]19Current NDC, Legacy NDC, 7 package rows20240901_2a13267f-c47f-4791-a8f9-4bbb5c804027.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993687buPROPion HCl 100 MG Oral TabletPSN2a13267f-c47f-4791-a8f9-4bbb5c80402722
993687bupropion hydrochloride 100 MG Oral TabletSCD2a13267f-c47f-4791-a8f9-4bbb5c80402722

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0182-17133501820160 TABLET, FILM COATED in 1 BOTTLE (71335-0182-1) 2018-07-240000-00-00NoNoCurrent
71335-0182-27133501820230 TABLET, FILM COATED in 1 BOTTLE (71335-0182-2) 2018-06-200000-00-00NoNoCurrent
71335-0182-371335018203100 TABLET, FILM COATED in 1 BOTTLE (71335-0182-3) 2024-07-090000-00-00NoNoCurrent
71335-0182-47133501820490 TABLET, FILM COATED in 1 BOTTLE (71335-0182-4) 2018-03-280000-00-00NoNoCurrent
71335-0182-571335018205120 TABLET, FILM COATED in 1 BOTTLE (71335-0182-5) 2024-07-090000-00-00NoNoCurrent
71335-0182-67133501820615 TABLET, FILM COATED in 1 BOTTLE (71335-0182-6) 2024-07-090000-00-00NoNoCurrent
71335-0182-77133501820721 TABLET, FILM COATED in 1 BOTTLE (71335-0182-7) 2021-04-280000-00-00NoNoCurrent