Bupropion Hydrochloride

Product NDC
71209-052
11-digit product format
712090052
Labeler code
71209
Product ID
71209-052_fff2e22d-64c2-425f-823f-a34664d4b1aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cadila Pharmaceuticals Limited
Application
ANDA208606
Marketing category
ANDA
Marketing start
2020-01-16
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
Rxcui993687, 993691

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
71209-052-05Bupropion Hydrochloride100 in 1 BOTTLETABLET, FILM COATED10013
71209-052-11Bupropion Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED100013
71209-052-17Bupropion Hydrochloride10 in 1 CARTONTABLET, FILM COATED1013
71209-052-17Bupropion Hydrochloride10 in 1 BLISTER PACKTABLET, FILM COATED1013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71209-052BUPROPION HYDROCHLORIDE TABLET, FILM COATED [CADILA PHARMACEUTICALS LIMITED]11Current NDC, Legacy NDC, 4 package rows20240306_33210109-2ddb-4b0f-a45e-988e493ca628.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993687buPROPion HCl 100 MG Oral TabletPSN33210109-2ddb-4b0f-a45e-988e493ca62813
993691buPROPion HCl 75 MG Oral TabletPSN33210109-2ddb-4b0f-a45e-988e493ca62813
993687bupropion hydrochloride 100 MG Oral TabletSCD33210109-2ddb-4b0f-a45e-988e493ca62813
993691bupropion hydrochloride 75 MG Oral TabletSCD33210109-2ddb-4b0f-a45e-988e493ca62813
993691bupropion HCl 75 MG Oral TabletSY33210109-2ddb-4b0f-a45e-988e493ca62813

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71209-052-0571209005205100 TABLET, FILM COATED in 1 BOTTLE (71209-052-05) 2023-01-120000-00-00NoNoCurrent
71209-052-11712090052111000 TABLET, FILM COATED in 1 BOTTLE (71209-052-11) 2023-01-120000-00-00NoNoCurrent
71209-052-177120900521710 BLISTER PACK in 1 CARTON (71209-052-17) / 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2023-01-120000-00-00NoNoCurrent