Bupropion Hydrochloride

Product NDC
71335-2312
11-digit product format
713352312
Labeler code
71335
Product ID
71335-2312_0de542bc-6bdc-426f-bfdd-e004fca8405c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA207479
Marketing category
ANDA
Marketing start
2017-04-12
Substance
BUPROPION HYDROCHLORIDE
Active strength
300 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
Brand name suffix
(XL)
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPROPION HYDROCHLORIDE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZG7E5POY8O
Rxcui993557

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
71335-2312-1Bupropion Hydrochloride(XL)30 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE30102
71335-2312-2Bupropion Hydrochloride(XL)60 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE60102
71335-2312-3Bupropion Hydrochloride(XL)90 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE90102
71335-2312-4Bupropion Hydrochloride(XL)120 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE120102
71335-2312-5Bupropion Hydrochloride(XL)8 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE8102
71335-2312-6Bupropion Hydrochloride(XL)180 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE180102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2312-1EA - Each71335-2312600e9e81-b1c3-498b-bf26-07e1a46334d812025-06-13
71335-2312-3EA - Each71335-231251455a65-4b1c-4e61-a953-27c3ab20fcf612025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2312BUPROPION HYDROCHLORIDE (XL) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]101Current NDC, 6 package rows20240726_8499470a-8d01-4348-b67b-8f49728031cb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSN8499470a-8d01-4348-b67b-8f49728031cb102
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCD8499470a-8d01-4348-b67b-8f49728031cb102
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSY8499470a-8d01-4348-b67b-8f49728031cb102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2312-17133523120130 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-2312-1) 2023-12-21NoNoHistorical
71335-2312-27133523120260 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-2312-2) 2023-12-21NoNoHistorical
71335-2312-37133523120390 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-2312-3) 2023-12-21NoNoHistorical
71335-2312-471335231204120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-2312-4) 2023-12-21NoNoHistorical
71335-2312-5713352312058 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-2312-5) 2023-12-21NoNoHistorical
71335-2312-671335231206180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-2312-6) 2023-12-21NoNoHistorical