FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
62332-127
11-digit product format
623320127
Labeler code
62332
Product ID
62332-127_ee494cd8-6374-4c6a-86f6-722c999e43e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA203013
Marketing category
ANDA
Marketing start
2024-01-10
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, 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
62332-127-31Bupropion Hydrochloride100 in 1 BOTTLETABLET, FILM COATED10011
62332-127-71Bupropion Hydrochloride500 in 1 BOTTLETABLET, FILM COATED50011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-127-31EA - Each62332-127d5021311-169d-45f4-9191-b552cc60255312024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-127BUPROPION HYDROCHLORIDE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS INC.]10Current NDC, 2 package rows20240905_b303a0ad-5971-44ab-937c-bcf3ff650358.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993687buPROPion HCl 100 MG Oral TabletPSNb303a0ad-5971-44ab-937c-bcf3ff65035811
993691buPROPion HCl 75 MG Oral TabletPSNb303a0ad-5971-44ab-937c-bcf3ff65035811
993687bupropion hydrochloride 100 MG Oral TabletSCDb303a0ad-5971-44ab-937c-bcf3ff65035811
993691bupropion hydrochloride 75 MG Oral TabletSCDb303a0ad-5971-44ab-937c-bcf3ff65035811
993691bupropion HCl 75 MG Oral TabletSYb303a0ad-5971-44ab-937c-bcf3ff65035811
993687buPROPion HCl 100 MG Oral TabletPSN990587bd-4c7d-4a36-8a38-3104648ab3a23
993687bupropion hydrochloride 100 MG Oral TabletSCD990587bd-4c7d-4a36-8a38-3104648ab3a23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
62332-127-3162332012731100 TABLET, FILM COATED in 1 BOTTLE (62332-127-31) 2024-01-10NoNoHistorical
62332-127-7162332012771500 TABLET, FILM COATED in 1 BOTTLE (62332-127-71) 2024-01-10NoNoHistorical