Bupropion hydrochloride

Product NDC
33261-797
11-digit product format
332610797
Labeler code
33261
Product ID
33261-797_7b3d0f95-398a-40f5-8c02-77031cf6de12
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA078866
Marketing category
ANDA
Marketing start
2010-04-08
Marketing end
0000-00-00
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
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4eceb285-f3c7-4092-a21a-4c9f3169f20cProduct name520260220
548ba7fd-fd0c-4a21-b2b0-d01bf93143b8Product name320240209
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
b8ee525f-67fb-39fb-91da-7e47ac54581dProduct name520200611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
98e65af1-f5d0-75d5-c930-f8a4ce4c3284Product name920190211
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
e4d463bc-c674-43cb-be06-82786f310d01Product name120150326
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
0916dcfb-331f-89b1-8eac-6f7dc76d82daProduct name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508
d7fc3d53-5a6c-de82-2808-1780f175f17eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-797-30Bupropion hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE301
33261-797-60Bupropion hydrochloride60 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE601
33261-797-90Bupropion hydrochloride90 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-797BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 3 package rows20140102_10a64abf-9704-4abb-98fb-bca228cab93a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993503buPROPion HCl 100 MG 12HR Extended Release Oral TabletPSN10a64abf-9704-4abb-98fb-bca228cab93a1
99350312 HR bupropion hydrochloride 100 MG Extended Release Oral TabletSCD10a64abf-9704-4abb-98fb-bca228cab93a1
993503bupropion HCl 100 MG 12 HR Extended Release Oral TabletSY10a64abf-9704-4abb-98fb-bca228cab93a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-797-303326107973030 in 1 BOTTLE, PLASTICHistorical
33261-797-603326107976060 in 1 BOTTLE, PLASTICHistorical
33261-797-903326107979090 in 1 BOTTLE, PLASTICHistorical