FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
43063-880
11-digit product format
430630880
Labeler code
43063
Product ID
43063-880_526dfa3a-0bfc-1590-e063-6394a90ac1cc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
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
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 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
43063-880-30Bupropion Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3023
43063-880-60Bupropion Hydrochloride60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-880-30EA - Each43063-8802a63b913-4ddf-4055-87df-9f7788adfd0a12018-09-05
43063-880-60EA - Each43063-8808d15b93e-41fb-42b2-9ca1-c03d9d1e8f5312018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-880BUPROPION HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]21Current NDC, Legacy NDC, 2 package rows20240719_b5c12c9a-62eb-481a-8099-7ad35242f7bf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993691buPROPion HCl 75 MG Oral TabletPSNb5c12c9a-62eb-481a-8099-7ad35242f7bf23
993691bupropion hydrochloride 75 MG Oral TabletSCDb5c12c9a-62eb-481a-8099-7ad35242f7bf23
993691bupropion HCl 75 MG Oral TabletSYb5c12c9a-62eb-481a-8099-7ad35242f7bf23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-880-304306308803030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-880-30) 2018-08-130000-00-00NoNoCurrent
43063-880-604306308806060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-880-60) 2018-10-300000-00-00NoNoCurrent